Effects of implant placement timing and type of soft-tissue grafting on histological and histomorphometric outcomes in a preclinical canine model.

AIM: To determine the effects of implant timing and type of soft-tissue grafting on histological and histomorphometric outcomes in a preclinical model. MATERIALS AND METHODS: Four implant placement protocols were randomly applied at the mesial root sites of the third and fourth mandibular premolars in 10 mongrel dogs: immediate placement (group IP), early placement (group EP), delayed placement with/without alveolar ridge preservation (groups ARP and DP, respectively). A connective-tissue graft (CTG) or porcine-derived volume-stable collagen matrix (VCMX) was applied to enhance the ridge profile (simultaneously with implant placement in group IP and staged for others), resulting in five sites for each combination. All dogs were sacrificed 3 months after soft-tissue grafting. Histological and histomorphometric analyses were performed, and the data were analysed descriptively. RESULTS: CTG and VCMX were difficult to differentiate from the augmented area. The median total tissue thickness on the buccal aspect of the implant was largest in group IP/CTG (between 2.78 and 3.87 mm). The soft-tissue thickness was generally favourable with CTG at all implant placement timings. Within the DP groups, CTG yielded statistically significantly larger total and soft-tissue thickness than VCMX (p < .05). Among the groups with VCMX, group EP/VCMX showed the largest soft-tissue thickness at apical levels to the implant shoulder. CONCLUSIONS: CTG generally led to greater tissue thickness than VCMX.

Flapless early implant placement into the uncalcified provisional matrix-Does it lead to osseointegration of the implant? A preclinical study.

AIM: To test whether early implant placement into the extraction socket containing an uncalcified provisional matrix leads to successful osseointegration and stable marginal bone levels. MATERIALS AND METHODS: In six mongrel dogs, the mandibular molars were extracted. Three weeks later, early implant placement was performed according to three experimental protocols: (i) flapless implant placement with preservation of the provisional matrix; (ii) flap elevation, socket debridement and implant placement; and (iii) flap elevation, socket debridement, implant placement and guided bone regeneration (GBR). One untreated extraction socket served as a control group. Data analyses were based on histologic slides 3 months after implant placement. RESULTS: There were no differences in bone-to-implant contact between the three experimental groups (66.97%, 58.89% and 60.89%, respectively) (inter-group comparison p = .42). Marginal bone levels, first bone-to-implant contact as well as the thickness of the connective tissue did not reveal any significant differences between the groups (p = .85, .60 and .65, respectively). CONCLUSIONS: Flapless early implant placement into posterior extraction sockets was as effective as an open flap approach in conjunction with GBR. Mineralization of the socket seems to occur irrespective of the presence of dental implants or biomaterials.

Impact of keratinized mucosa on implant-health related parameters: A 10-year prospective re-analysis study.

AIM: To investigate whether the lack of keratinized mucosa (KM) affects peri-implant health after 10 years of loading. MATERIALS AND METHODS: Data from 74 patients with 148 implants from two randomized controlled studies comparing different implant systems were included and analyzed. Clinical parameters including bleeding on probing (BOP), probing depth (PD), plaque index, marginal bone loss (MBL), and KM width (KMW) at buccal sites were collected at baseline (time of the final prosthesis insertion), 5-year and 10 years postloading. Multivariable logistic and linear regression models by means of a generalized estimated equation (GEE) were used to evaluate the influence of buccal KM on peri-implant clinical parameters; BOP, MBL, PD, and adjusted for implant type (one-piece or two-piece) and compliance. RESULTS: A total of 35 (24.8%) implants were healthy, 67 (47.5%) had mucositis and 39 (27.6%) were affected by peri-implantitis. In absence of buccal KM (KM = 0 mm), 75% of the implants exhibited mucositis, while in the presence of KM (KMW >0 mm) 41.2% exhibited mucositis. Regarding peri-implantitis, the corresponding percentages were 20% (KM = 0 mm) and 26.7% (KM >0 mm). Unadjusted logistic regression showed that the presence of buccal KM tended to reduce the odds of showing BOP at buccal sites (OR: 0.28 [95% CI, 0.07 to 1.09], p = 0.06). The adjusted logistic regression model revealed that having buccal KM (OR: 0.21 [95% CI, 0.05 to 0.85], p = 0.02) and using two-piece implants (OR: 0.34 [95% CI, 0.15 to 0.75], p = 0.008) significantly reduced the odds of showing BOP. Adjusted linear regression by means of GEE showed that KM and two-piece implants were associated with reduced MBL and MBL changes (p < 0.05). CONCLUSION: The lack of buccal KM appears to be linked with peri-implant parameters such as BOP and MBL, but the association is weak. The design of one-piece implants may account for their increased odds of exhibiting BOP.

Augmentation of keratinized tissue using autogenous soft-tissue grafts and collagen-based soft-tissue substitutes at teeth and dental implants: Histological findings in a pilot pre-clinical study.

AIM: To histomorphometrically assess three treatment modalities for gaining keratinized tissue (KT) at teeth and at dental implants. MATERIALS AND METHODS: In five dogs, the distal roots of the mandibular second, third and fourth premolars were extracted. Dental implants were placed at the distal root areas 2 months later. After another 2 months, KT augmentation was performed at both distal (implants) and at mesial root (teeth) areas in the presence (wKT groups) or absence (w/oKT groups) of a KT band at the mucosal/gingival level. Three treatment modalities were applied randomly: apically positioned flap only (APF), free gingival grafts (FGGs) and xenogeneic collagen matrices (XCMs). A combination of the above produced six groups. Two months later, tissue sections were harvested and analysed histomorphometrically. RESULTS: The median KT height and length were greatest at implants with FGG in both wKT (3.7 and 5.1 mm, respectively) and w/oKT groups (3.7 and 4.6 mm), and at teeth with FGG in wKT groups (3.7 and 6.1 mm) and with APF in the w/oKT groups (3.9 and 4.4 mm). The XCM and APF produced more favourable results at teeth than at implants. CONCLUSIONS: FGG was advantageous in gaining KT, especially at implants.

Randomized controlled multi-centre study comparing shorter dental implants (6 mm) to longer dental implants (11-15 mm) in combination with sinus floor elevation procedures: 10-year data.

AIM: To compare implant survival and complication rates between shorter and standard-length implants with sinus augmentation and restored with single crowns, at 10 years of loading. MATERIALS AND METHODS: One-hundred and one patients (137 implants) with a ridge height of 5-7 mm in the posterior maxilla were randomly assigned to two treatment modalities: shorter implants (6 mm) (group short [GS]) or standard-length implants (11-15 mm) with sinus grafting (group graft [GG]). Following the insertion of final restorations, patients were regularly recalled for up to 10 years. Assessed outcomes encompassed implant survival, marginal bone levels (MBLs), biological and technical parameters and patient-reported outcome measures (OHIP-49 = Oral Health Impact Profile). Non-parametric statistical analysis was used to analyse the data. RESULTS: For the 5- to 10-year follow-up period, 77 patients with 105 implants (GS: 36 patients/48 implants; GG: 41/57) were available for re-examination (drop-out rate 21%). Implant survival rates at the patient level were 96.0% (GS; 2 failures) and 100% (GG) (inter-group p = .24). Median MBLs amounted to 0.00 mm (min 0.00; max 3.25; GS) and 0.00 mm (min 0.00; max 4.55; GG) (inter-group p = .73). Technical complications predominantly occurred within the first 5 years (inter-group p > .05). Peri-implantitis rates were 4.2% (GS) and 13.3% (GG) (intergroup p = .37). Median OHIP-49 scores were 7.00 (0.00; 39.00; GS) and 9.00 (0.00; 196; GG) (inter-group p = .61) at 10 years. CONCLUSIONS: Based on similar 10-year implant survival rates, reduced patient morbidity and lower costs, the use of shorter dental implants might well serve as an alternative treatment concept to longer implants placed in conjunction with sinus grafting for patients with a limited ridge height in the posterior maxilla. Study register: https://clinicaltrials.gov/ct2/show/NCT01030523.

Clinical and histological wound healing patterns of collagen-based substitutes: An experimental randomized controlled trial in standardized palatal defects in humans.

AIM: To evaluate the progression of wound healing of standardized palatal defects in groups using three different collagen-based wound dressings and a control group, in terms of wound closure, pain perception and descriptive histology. MATERIALS AND METHODS: Twenty participants were enrolled in this experimental study, in whom four palatal defects were created. The defects (6 mm diameter, 3 mm depth) were randomly assigned to one of four treatment modalities: C (control), MG (Mucograft®), MD (mucoderm®) and FG (Fibro-Gide®). Photographs were taken, and pain assessment was performed before and after treatment and at 5, 7, 9, 12, 14 and 16 days after surgery. All participants wore a palatal splint for a duration of 16 days. RESULTS: All groups achieved complete wound closure at 14 days. The percentage of the remaining open wound on day 7 amounted to 49.3% (C; interquartile range [IQR]: 22.6), 70.1% (FG; IQR: 20.7), 56.8% (MD; IQR: 26.3) and 62.2% (MG; IQR: 34.4). Statistically significant differences were found between FG and C (p =.01) and between MD and FG (p =.04). None of the participants rated pain higher than 4 out of 10 during the entire study period. CONCLUSIONS: Collagen-based wound dressings provide coverage of open defects, albeit without acceleration of wound closure or reduction of pain. FG (which is not intended for open oral wounds) showed slower wound closure compared to C and MD.

Clinical Outcomes of Tooth- and Implant-Supported Restorations Performed in a University-based Undergraduate Program after 13-15 Years.

AIMS: To assess the clinical concept of patient treatment with fixed tooth- and implant-supported restorations in a university-based undergraduate program after 13 - 15 years. METHODS: Thirty patients (mean age 56 years) who had received multiple tooth- and implant-supported restorations were recalled after 13-15 years. The clinical assessment comprised of biological and technical parameters as well as patient satisfaction. Data were analyzed descriptively and the 13-15-year survival rates for tooth- and implant-supported single crowns and fixed dental prostheses were calculated. RESULTS: The survival rate of tooth-supported restorations amounted to 88.3% (single crowns) and 69.6% (fixed dental prostheses); in implants it reached 100% for all types of reconstructions. Overall, 92.4% of all reconstructions were free of technical complications. The most common technical complication was chipping of the veneering ceramic (tooth-supported restorations: 5.5%; implant-supported restorations: 13-15.9%) regardless of the material used. At teeth, increased probing depth ≥5mm was the most frequent biological complication (22.8%), followed by endodontic complications of root-canal treated teeth (14%) and loss of vitality at abutment teeth (8.2%). Peri-implantitis was diagnosed in 10.2% of implants. CONCLUSION: Results of this study indicate that the clinical concept implemented in the undergraduate program and performed by undergraduate students works well. The clinical outcomes are similar to those reported in the literature. In general, the majority of biological complications occurrs in reconstructed teeth, whereas implant-supported restorations are more prone to technical complications.

Ridge preservation using a self-retaining block type bone substitute for extraction sockets with buccal dehiscence defects - A preclinical study.

OBJECTIVE: To evaluate the effect of a self-retaining block-type bone substitute (srBB) on the dimensional stability of the horizontal ridge width at the coronal level in a buccal dehiscence model. MATERIALS AND METHODS: Four box-shaped bone defects with a buccal dehiscence were surgically prepared in the partially edentulous mandible (n = 6). Experimental biomaterials were randomly assigned to each site: (1) Control group: no treatment, (2) particle-type bone substitute (PBS) group, (3) collagenated soft block bone substitute (csBB) group, and (4) self-retaining synthetic block bone (srBB) group. In all grafted groups, a collagen membrane covered the biomaterials. At 16 weeks, clinical, histological, and radiographic analyses were performed. RESULTS: Three of the six blocks in the srBB group became exposed and fell out during the first week after surgery. Therefore, the remaining three specimens were renamed RsrBB group. The RsrBB group showed an increase horizontal ridge compared to the pristine bone width at 2-4 mm below the CEJ, while the other groups showed resorption (augmented width at 2 mm below: 4.2, 42.4, 36.2, and 110.1% in the control, PBS, csBB, and RsrBB groups, respectively). The mineralized bone area was largest in the RsrBB group (4.74, 3.44, 5.67, and 7.77 mm2 in the control, PBS, csBB, and RsrBB groups, respectively.). CONCLUSIONS: The srBB group demonstrated the highest volume stability at the coronal level. These findings would potentially suggest that self-retaining block bone substitute might be a good candidate for alveolar ridge preservation.

Survival and complication rates of two dental implant systems supporting fixed restorations: 10-year data of a randomized controlled clinical study.

OBJECTIVES: To compare clinical, radiographic, biological and technical long-term outcomes of two types of dental implants over a period of 10 years. MATERIALS AND METHODS: Ninety-eight implants were placed in 64 patients, randomly allocated to one of two manufacturers (AST and STM). All implants were loaded with fixed restorations. Outcome measures were assessed at implant insertion (Ti), at baseline examination (TL), at 1, 3, 5, 8 and 10 (T10) years. Data analysis included survival, bone level changes, complications and clinical measures. RESULTS: Re-examination was performed in 43 patients (23 AST and 20 STM) at 10 years. The implant level analysis was based on 37 (AST) and 32 (STM) implants. Survival rates of 100% were obtained for both groups. The median changes of the marginal bone levels between baseline and T10 (the primary endpoint) amounted to a loss of 0.07 mm for group AST and a gain of 0.37 mm for group STM (intergroup p = 0.008). Technical complications occurred in 27.0% of the implants in group AST and in 15.6% in group STM. The prevalence of peri-implant mucositis was 29.7% (AST) and 50.1% (STM). The prevalence of peri-implantitis amounted to 0% (AST) and 6.3% (STM). CONCLUSIONS: Irrespective of the implant system used, the survival rates after 10 years were high. Minimal bone level changes were observed, statistically significant but clinically negligible in favor of STM. Technical complications were more frequently encountered in group AST, while group STM had a higher prevalence of peri-implant mucositis.

Stromal cells associated with soft tissue augmentation by a volume stable collagen matrix (VCMX) are predominated by anti-inflammatory/reparative macrophages.

Aim: To define immunophenotypes of stromal inflammatory and endothelial cells and fibroblasts 3-months post-augmentation of the peri-implant soft tissue using a porcine cross-linked collagen matrix (VCMX). Methods: Peri-implant soft tissue samples were obtained from 12 patients at the lining mucosa (LM) - masticatory mucosa (MM) junction, before and at 3-months post-augmentation. Immunohistochemical stains for identification of inflammatory cells [T (CD3) and B (CD20) lymphocytes, plasma cells (CD138)], macrophages (CD68-pro-inflammatory, CD163-anti-inflammatory/reparative), endothelial cells (CD31, CD34) and fibroblasts (CD90, TE-7), were performed. Differences in the mean positively-stained cells pre- and post-augmentation was analyzed by Wilcoxon Signed-Rank Test. Results: CD31+ endothelial cells showed increased mean numbers in MM2 compared to MM1 (p=0.025) and in LM2 compared to LM1 (p=0.047). CD163+ anti-inflammatory macrophages showed mean numbers in MM2 higher than MM1 (p=0.021) and in LM2 than LM1 (p=0.012). All other cell phenotypes showed insignificant changes between pre- and post-augmentation. Conclusion: This molecular study provided novel insight on the frequency of phenotypes of stromal cells in the wound healing process 3-months post-augmentation with VCMX, with anti-inflammatory CD163+ macrophages being predominant. This should be further investigated in order to find novel therapeutic approaches to modulate and promote the VCMX-related healing process.

Efficacy of a collagen matrix for soft tissue augmentation after implant placement compared to connective tissue grafts: A multicenter, noninferiority, randomized controlled trial.

OBJECTIVES: To test whether soft tissue volume augmentation using a collagen matrix (VCMX) leads to noninferior results in terms of gain of mucosal thickness at single implant sites, compared to connective tissue grafts (SCTG). METHODS: The study was designed as a multi-center randomized controlled clinical trial. Subjects in need of soft tissue volume augmentation at single tooth implant sites were consecutively recruited at nine centers. The deficient mucosal thickness at the implant sites (one per patient) was augmented by applying either a VCMX or a SCTG. Patients were examined at 120 days (abutment connection = primary endpoint), 180 days (final restoration), and 360 days (1-year after insertion of the final restoration). Outcome measures included: transmucosal probing of the mucosal thickness (crestal = primary outcome), profilometric measurements of the tissue volume, and patient-reported outcome measures (PROMs). RESULTS: Out of the 88 patients, 79 attended the one-year follow-up. The median increase of the crestal mucosal thickness between pre-augmentation and 120 days was 0.3 ± 2.1 mm in the VCMX group and 0.8 ± 1.6 mm in the SCTG group (p = .455). Non-inferiority of the VCMX compared to the SCTG was not observed. The respective numbers at the buccal aspect amounted to 0.9 ± 2.0 mm (VCMX) and 1.1 ± 1.4 mm (SCTG; p = .431). PROMs including pain perception favored the VCMX group. CONCLUSION: It remains inconclusive whether soft tissue augmentation using a VCMX is noninferior to SCTG in terms of crestal mucosal thickening at single implant sites. However, the use of collagen matrices favors PROMs especially pain perception, while achieving similar buccal volume gains along with comparable clinical and aesthetic parameters to SCTG.

Early implant placement in sites with ridge preservation or spontaneous healing: histologic, profilometric, and CBCT analyses of an exploratory RCT.

PURPOSE: The aim of this study was to compare changes in soft and hard tissue and the histologic composition following early implant placement in sites with alveolar ridge preservation or spontaneous healing (SH), as well as implant performance up to 1 year after crown insertion. METHODS: Thirty-five patients with either intact buccal bone plates or dehiscence of up to 50% following single-tooth extraction of incisors, canines, or premolars were included in the study. They were randomly assigned to undergo one of three procedures: deproteinized bovine bone mineral with 10% collagen (DBBM-C) covered by a collagen matrix (DBBM-C/CM), DBBM-C alone, or SH. At 8 weeks, implant placement was carried out, and cone-beam computed tomography scans and impressions were obtained for profilometric analysis. Patients were followed up after the final crown insertion and again at 1 year post-procedure. RESULTS: Within the first 8 weeks following tooth extraction, the median height of the buccal soft tissue contour changed by -2.11 mm for the DBBM-C/CM group, -1.62 mm for the DBBM-C group, and -1.93 mm for the SH group. The corresponding height of the buccal mineralized tissue changed by -0.27 mm for the DBBM-C/CM group, -2.73 mm for the DBBM-C group, and -1.48mm for the SH group. The median contour changes between crown insertion and 1 year were -0.19 mm in the DBBM-C/CM group, -0.09 mm in the DBBM-C group, and -0.29 mm in the SH group. CONCLUSIONS: Major vertical and horizontal ridge contour changes occurred, irrespective of the treatment modality, up to 8 weeks following tooth extraction. The DBBM-C/CM preserved more mineralized tissue throughout this period, despite a substantial reduction in the overall contour. All 3 protocols led to stable tissues for up to 1 year.

The 3D emergence profile on implant-supported restorations: A method for evaluating restorative angles.

STATEMENT OF PROBLEM: Emerging evidence indicates that the emergence profile and subsequent restorative angle play a crucial role in clinical outcomes and can potentially affect the development and progression of peri-implant diseases. However, the traditional evaluation of the emergence profile and angle has been limited to mesial and distal sites using periapical x-rays, without considering the buccal sites. PURPOSE: To describe a novel 3D method to estimate the emergence profile and restorative angles around single implant-supported crowns including buccal sites. MATERIALS AND METHODS: A total of 30 implant-supported crowns (11 molars, 8 premolars, 8 central incisors and 1 canine) were extra-orally scanned using an intraoral scanner and the STL files produced were imported into a 3D software. The crown/abutment interface of each crown was delineated, and apico-coronal lines were automatically drawn following the shape of the crown. Three reference points were defined on the apico-coronal lines at the transition edge of the biological (BC) and the esthetic zone (EC) and the resulting angles were then calculated. The reliability of the measurements (2D and 3D) were assessed using the intraclass correlation coefficient (ICC). RESULTS: In anterior restorations, the mean angle of the esthetic zone amounted to 162 ± 14° at mesial sites, to 140 ± 10° at buccal sites and to 163 ± 11° at distal sites. The corresponding angles at the biological zones, amounted to 155 ± 13° at mesial sites, 139 ± 15° at buccal sites and 157 ± 5° at distal sites. In posterior restorations, the mean angle of the esthetic zone amounted to 162 ± 12° at mesial sites, to 157 ± 13 at buccal sites and to 162 ± 11 at distal sites. The corresponding angles at the biological zone, amounted to 158 ± 8 at mesial sites, 150 ± 15° at buccal sites and 156 ± 10 at distal sites. The ICC for all measurements ranged between 0.77 and 0.99 indicating a good intra-examiner reliability. CONCLUSION: Within the limitations of the present study, the 3D analysis seems to be a reliable and applicable method for the quantitative evaluation of the emergence profile in daily practice. Future randomized clinical trials are needed to assess whether a 3D analysis with the ensuing the emergence profile serves as a predictor for clinical outcomes. CLINICAL SIGNIFICANCE: The development and implementation of a 3D workflow will provide technicians and dentists with the ability to assess the restorative angle of implant-supported restorations during the provisional phase and the final restoration. This approach may help achieve an aesthetically pleasing restoration while minimizing potential clinical complications.

Soft tissue contour changes at implant sites with or without soft tissue grafting in the esthetic zone: A retrospective case-control study with a 12-year follow-up.

OBJECTIVES: To evaluate the volumetric changes and peri-implant health at implant sites with and without previous soft tissue grafting over a 12-year observation period. MATERIALS AND METHODS: Eighteen patients received dental implants and simultaneously guided bone regeneration in the esthetic zone (15-25) for dental rehabilitation. Three months following implant placement, 8 patients (test) received an additional subepithelial connective tissue graft, whereas 10 patients (control) did not receive any additional treatment. One week after prothesis delivery and at the 5 and 12 years follow-up examination, impressions were taken. Obtained casts were processed for profilometric and linear analyses. The mean distance (MD) in the mid-buccal area between the two surfaces was considered the primary outcome. Peri-implant health was assessed based on clinical and radiographic data. RESULTS: Nine female and 7 male patients were re-assessed after a median follow-up time of 144.5 months (Min: 114.8; Max: 213.0). The median reduction of MD amounted to -0.81 mm (Min: -1.39; Max: 0.52) in the test group and -0.56 mm (Min: -0.93; Max: 0.11) in the control group, (intergroup comparison p = .607, CI 95%: -0.760/0.530). None of the implants was diagnosed with peri-implantitis. Six tests and two control implants were diagnosed with peri-implant mucositis (p = .103). CONCLUSIONS: Despite the limited number of included patients, similar results in terms of volumetric, linear changes, and peri-implant conditions could be detected at implant sites with or without soft tissue grafting over a period of 12 years.

The peri-implant mucosa color: A systematic appraisal of methods for its assessment and clinical significance.

BACKGROUND: Peri-implant mucosa color (PMC) seems to be one of the main parameters affecting the esthetic outcome of implant therapy. However, more emphasis should be given to its assessment and reporting. PURPOSE: To describe the available evidence on methods to assess and report the color of the peri-implant mucosa (PMC) and the respective clinical relevance. MATERIAL AND METHODS: A comprehensive electronic and manual search was performed to identify clinical studies reporting on PMC. RESULTS: A total of 121 studies were included. PMC was evaluated at the time of the follow-up visit (chairside) in 45.5% studies. PMC assessment was performed qualitatively, by comparing PMC with adjacent and/or contralateral gingiva (78.6%) or quantitatively, using spectrophotometry (20.7%) or a software on clinical photographs (0.8%). The most performed method to assess PMC was through esthetic indices (76.9%), either at the time of the follow-up visit (chairside) or at later time point using photographs. Quantitative reporting of PMC included averages of points from esthetic indices or color differences to natural gingiva expressed with the CIELAB color system. PMC assessment allowed describing color discrepancies compared to natural gingiva, evaluating color changes over time, and comparing the outcomes of different treatment modalities. PMC assessment through spectrophotometry was additionally utilized to assess the role of mucosal thickness (MT) on PMC. CONCLUSIONS: Various methods for PMC assessment and reporting were described, including visual assessment, mainly through esthetic indices, and spectrophotometry. PMC evaluation has allowed to demonstrate the factors affecting the color of the peri-implant soft tissue, such as the type of abutment/restoration, MT, and soft tissue augmentation.

Tissue integration and biodegradation of soft tissue substitutes with and without compression: an experimental study in the rat.

OBJECTIVES: To analyze the influence of compression on tissue integration and degradation of soft tissue substitutes. MATERIAL AND METHODS: Six subcutaneous pouches in twenty-eight rats were prepared and boxes made of Al2O3 were implanted and used as carriers for soft tissue substitutes: a collagen matrix (MG), two volume-stable collagen matrices (FG/MGA), and a polycaprolactone scaffold(E). The volume-stable materials (FG/MGA/E) were further implanted with a twofold (2) and a fourfold (4) compression, created by the stacking of additional layers of the substitute materials. The samples were retrieved at 1, 2, and 12 weeks (10 groups, 3 time points, n = 5 per time point and group, overall, 150 samples). The area fraction of infiltrated fibroblasts and inflammatory cells was evaluated histologically. Due to within-subject comparisons, mixed models were conducted for the primary outcome. The level of significance was set at 5%. RESULTS: The area fraction of fibroblasts increased in all groups over time. At 12 weeks, the densely compressed materials FG4 (1.1%), MGA4 (1.7%), and MGA2 (2.5%) obtained lower values as compared to the other groups, ranging between 4.7 (E2) and 6.5% (MG). Statistically significant differences (p ≤ 0.05) were observed between groups FG4 vs MG/FG2/E/E4 as well as between MGA4 vs MG/FG2/E/E4 and E vs MGA2. CONCLUSIONS: Higher levels of compression led to delayed tissue integration. The effect of different compression levels was more distinct when compared to the differences between the materials. CLINICAL RELEVANCE: All biomaterials demonstrated tissue integration and a minimal concomitant inflammatory reaction. Clinically, it might be more favorable to obtain a sufficient flap release or to reduce the material size to improve the tissue integration processes.

Minimal invasiveness in soft tissue augmentation at dental implants: A systematic review and meta-analysis of patient-reported outcome measures.

The aim of this study was to compare patient-reported outcome measures (PROMs) of soft tissue substitutes versus autogenous grafts for soft tissue augmentation procedures at implant sites. Comprehensive and systematic literature searches were performed until December 2021. A focused question was formulated based on the Population, Intervention, Comparison and Outcome criteria (PICO): In patients with dental implants undergoing soft tissue augmentation (P), do soft tissue substitutes (I) compared to autogenous soft tissue graft (SCTG [subepithelial connective tissue graft]) (C) limit the post-operative morbidity and other patient reported-outcomes measures (O). Randomized controlled clinical trials, prospective-, retrospective- and case-series studies were included. Meta-analyses were performed whenever possible and the results were expressed as weighted mean differences (WMD). A total of 29 clinical studies were included. For mucosal thickness gain, soft tissue substitutes significantly reduced the pain perception compared to SCTG (n = 4; WMD = 14.91 Visual Analog Scale [VAS] units; 95% confidence interval [CI] 6.42-23.40; P < .0006) based on a 0-100 VAS scale. Based on a 0-10 VAS scale, a borderline significance of pain reduction was found when soft tissue substitutes were applied (n = 4; WMD = 1.62 VAS units; 95% CI 0.01-3.23; P = .05). For keratinized tissue gain, soft tissue substitutes significantly reduced the pain perception after keratinized tissue augmentation compared to SCTG based on a 0-100 VAS scale (n = 2; WMD = 21.43 VAS units; 95% CI 12.58-30.28; P < .0001). Based on the 0-10 VAS scale, soft tissue substitutes significantly reduced the pain as compared to SCTG (n = 4; WMD = 1.65 VAS units; 95% CI 0.66-2.64; P = .001). Regarding pain medication, soft tissue substitutes required less painkillers (n = 6; WMD = 1.56 tablets; 95% CI 1.22-1.91; P < .00001) after soft tissue augmentation. The surgery time was significantly reduced when soft tissue substitutes were used (n = 5; WMD = 10.9 minutes; 95% CI 4.60-17.19; P < .00001). There were no significant differences in satisfaction, aesthetics, and quality of life (OHIP-14) between soft tissue substitutes and autogenous grafts following soft tissue augmentation at implants sites. Soft tissue substitutes, compared to autogenous grafts, significantly improve PROMs following soft tissue augmentation at implant sites. Soft tissue substitutes can reduce pain perception, amounts of painkillers and surgery time while achieving similar levels of patient´s satisfaction as autogenous grafts without impairing the clinical outcomes. The current evidence indicates that they constitute a valid and reliable alternative to minimize the invasiveness in soft tissue augmentation procedures at implant sites.

Soft tissue augmentation with a volume-stable collagen matrix or an autogenous connective tissue graft at implant sites: Five-year results of a randomized controlled trial post implant loading.

BACKGROUND: Interventions to augment the mucosal thickness around dental implants are indicated to optimize esthetics and maintain peri-implant health. However, there is a lack of clinical data on the long-term performance of soft tissue substitutes, such as volume-stable collagen matrix (VCMX), compared to autogenous grafts, such as subepithelial connective tissue grafts (SCTGs). This randomized controlled trial aimed to assess 5-year data on clinical and radiographic outcomes at implant sites previously augmented with VCMX or SCTG. METHODS: Twenty patients were randomly assigned for soft tissue augmentation with VCMX or SCTG at single implant sites. Following abutment connection, final restorations were inserted (baseline; BL) and patients were reexamined up to 5 years (FU-5). Measurements included clinical data, marginal bone levels, mucosal thickness, and ridge contour changes. Nonparametric tests and estimates were applied for the statistical analysis. RESULTS: The median buccal mucosal thickness increased by 0.3 mm (Q1: -0.8; Q3: 1.0) in the VCMX group (P = 0.656) and 0.3 mm (Q1: 0.0; Q3: 1.0) in the SCTG group (P = 0.188) between BL and FU-5 (intergroup P = 0.752), while the ridge contour decreased by a median of -0.3 mm (-0.9; -0.1) (P = 0.078) for VCMX and -0.3 mm (-0.4; -0.2) (P = 0.039) for SCTG (intergroup P = 0.817). Peri-implant health was maintained in both groups with stable clinical and radiographic outcomes and without significant differences between the treatments. CONCLUSION: Despite the limited power and considerable dropout rate in the present study, soft tissue augmentation at implant sites with either VCMX or SCTG resulted in similar stable peri-implant tissues, favorable esthetics, and clinically negligible contour changes at 5 years post loading.

Outcome measures and methods of assessment of soft tissue augmentation interventions in the context of dental implant therapy: A systematic review of clinical studies published in the last 10 years.

AIM: To identify and report outcome measures and methods of assessment on soft tissue augmentation interventions in the context of dental implant therapy reported in clinical studies published in the last 10 years. MATERIALS AND METHODS: The protocol of this Preferred Reporting Items of Systematic Reviews and Meta-Analyses (PRISMA) 2020-compliant systematic review was registered in PROSPERO (CRD42021252214). A literature search was conducted to identify articles that met the pre-established eligibility criteria. Data of interest, with an emphasis on outcome measures, were extracted. For each outcome, specific methods and timing of assessment were described in detail. Following a critical qualitative analysis of the data, outcome measures were categorized. Primary outcomes were identified, and the frequency of reporting in the selected articles was calculated. Additionally, risk-of-bias assessments were performed for individual articles and primary outcomes. RESULTS: Ninety-two articles, of which 39 reported randomized controlled trials (RCTs), 20 non-RCTs, and 33 case series studies, were selected. Outcome measures were categorized into either investigator-evaluated outcome measures (i.e., clinical, digital imaging, aesthetic, histological, biomarker, and safety) or patient-reported outcome measures (PROMs). Clinical outcomes were the most frequently reported type of outcome. Considering all categories, the most frequently reported primary outcomes were facial mucosa thickness assessed with clinical methods (22.83%), facial keratinized mucosa width assessed with clinical methods (19.57%), facial mucosal margin position/recession assessed with clinical methods (18.48%), facial mucosa thickness assessed with digital imaging methods (11.96%), facial soft tissue volume assessed with digital imaging methods (9.78%), and supracrestal tissue height assessed with clinical methods (9.78%). No distinguishable patterns of association between specific types or quality (level of bias) of clinical studies and the choice of primary outcomes were observed. CONCLUSIONS: Clinical research on peri-implant soft tissue augmentation has progressively increased in the last 10 years. Although clinical outcome measures were the most frequently reported outcomes in the selected literature, trends in the field are indicative of a shift from traditional clinical assessment methods to the use of digital technologies. PROMs were generally under-reported but should be considered an integral methodological component in future clinical studies.

Outcome measures and methods of assessment of soft-tissue augmentation interventions in the context of dental implant therapy: A systematic review of clinical studies published in the last 10 years.

AIM: The aim of the study was to identify and report outcome measures and methods of assessment on soft-tissue augmentation interventions in the context of dental implant therapy reported in clinical studies published in the last 10 years. MATERIAL AND METHODS: The protocol of this PRISMA 2020-compliant systematic review was registered in PROSPERO (CRD42021252214). A literature search was conducted to identify articles that met the pre-established eligibility criteria. Data of interest, with an emphasis on outcome measures, were extracted. For each outcome, specific methods and timing of assessment were described in detail. Following a critical qualitative analysis of the data, outcome measures were categorized. Primary outcomes were identified and the frequency of reporting in the selected articles was calculated. Additionally, risk of bias assessments were performed for individual articles and primary outcomes. RESULTS: Ninety-two articles, of which 39 reported randomized controlled trials (RCTs), 20 reported non-RCTs, and 33 reported case series studies, were selected. Outcome measures were categorized into either investigator-evaluated outcome measures (i.e., clinical, digital imaging, esthetic, histologic, biomarker, and safety) or patient-reported outcome measures (PROMs). Clinical outcomes were the most frequently reported type of outcome. Considering all categories, the most frequently reported primary outcomes were facial mucosa thickness assessed with clinical methods (22.83%), facial keratinized mucosa width assessed with clinical methods (19.57%), facial mucosal margin position/recession assessed with clinical methods (18.48%), facial mucosa thickness assessed with digital imaging methods (11.96%), facial soft-tissue volume assessed with digital imaging methods (9.78%), and supracrestal tissue height assessed with clinical methods (9.78%). No distinguishable patterns of association between specific types or quality (level of bias) of clinical studies and the choice of primary outcomes were observed. CONCLUSION: Clinical research on peri-implant soft-tissue augmentation has progressively increased in the last 10 years. Although clinical outcome measures were the most frequently reported outcomes in the selected literature, trends in the field are indicative of a shift from traditional clinical assessment methods to the use of digital technologies. PROMs were generally underreported but should be considered an integral methodological component in future clinical studies.