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.

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.

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.

Is transmucosal healing of an implant as effective as submerged healing when simultaneous guided bone regeneration is performed? A preclinical study.

AIM: To investigate whether transmucosal healing is as effective as submerged healing in terms of buccal bone regeneration when guided bone regeneration (GBR) is performed simultaneously with implant placement. MATERIALS AND METHODS: In six dogs, buccal dehiscence defects were created in the edentulous mandibular ridge, sized 5 × 5 × 3 mm (length × height × depth). In each defect, a bone-level implant was placed, and four experimental groups were randomly assigned as follows: (i) transmucosal healing with GBR (T-GBR), (ii) transmucosal healing without GBR (T-control), (iii) submerged healing with GBR (S-GBR) and (iv) submerged healing without GBR (S-control). Data analyses were based on histological slides 5 months after implant placement. RESULTS: The T-GBR group showed significant differences compared to the control groups regarding defect height resolution, buccal bone thickness and mineralized tissue area (p < .05), but showed no significant differences when compared with the S-GBR group (p > .05). CONCLUSIONS: The mode of healing (transmucosal vs. submerged) does not influence bone regeneration at implant sites. The clinician may therefore choose the approach based on further clinical and patient-specific parameters.

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.

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.

The use of digital technologies in peri-implant soft tissue augmentation - A narrative review on planning, measurements, monitoring and aesthetics.

OBJECTIVE: To identify the different uses and modalities of digital technologies to diagnose, plan and monitor peri-implant soft tissue conditions and aesthetics. METHODS: A comprehensive narrative review of pertinent literature was conducted, critically appraising key digital technologies that may assist peri-implant soft tissue augmentation and assessment. An electronic search on four databases including studies published prior to 1st July 2023 was performed and supplemented by a manual search. RESULTS: Predominantly, tools such as cone beam computed tomography (CBCT), intraoral scanning (iOS), intraoral ultrasonography and digital spectrophotometry were commonly to assess and monitor peri-implant soft tissues. The main clinical and research applications included: (i) initial assessment of mucosal thickness, supra-crestal tissue height and keratinized mucosa width, (ii) evaluation of peri-implant soft tissue health and inflammation, (iii) monitoring profilometric changes and midfacial mucosal margin stability over time and (iv) aesthetic evaluation through colour assessment. While evidence for some digital tools may be limited, the integration of digital technologies into peri-implant soft tissue management holds great promise. These technologies offer improved precision, comfort and speed in assessment, benefiting both patients and clinicians. CONCLUSION: As digital technologies progress, their full potential in peri-implant soft tissue augmentation and their value will become more evident with ongoing research. Embracing these innovations and their potential benefits is recommended to ensure that during progress in implant dentistry, patient care is not hindered.

Enhancing guided bone regeneration with cross-linked collagen-conjugated xenogeneic bone blocks and membrane fixation: A preclinical in vivo study.

OBJECTIVE: To determine whether combining cross-linked (CL) collagen-integrated xenogeneic bone blocks stabilized with the fixation of resorbable collagen membranes (CM) can enhance guided bone regeneration (GBR) in the overaugmented calvarial defect model. MATERIALS AND METHODS: Four circular defects with a diameter of 8 mm were prepared in the calvarium of 13 rabbits. Defects were randomly assigned to receive one of the following treatments: (i) non-cross-linked (NCL) porcine-derived collagen-embedded bone block covered by a CM without fixation (NCL + unfix group); (ii) NCL bone block covered by CM with fixation using bone-tack (NCL + fix group); (iii) cross-linked (CL) porcine-derived collagen-embedded bone block covered by CM without fixation (CL + unfix group); and (iv) CL bone block covered by CM with fixation using bone-tack fixation (CL + fix group). The efficacy of GBR was assessed through histological and molecular analyses after 2 and 8 weeks. RESULTS: At 2 weeks, there were no significant differences in histologically measured areas of newly formed bone among the groups. At 8 weeks, however, the CL + fix group exhibited a larger area of new bone (5.08 ± 1.09 mm2, mean ± standard deviation) compared to the NCL + unfix (1.62 ± 0.42 mm2; p < .0083), NCL + fix (3.97 ± 1.39 mm2) and CL + unfix (2.55 ± 1.04 mm2) groups. Additionally, the expression levels of tumour necrosis factor-alpha, fibroblast growth factor-2, vascular endothelial growth factor, osteocalcin and calcitonin receptor were significantly higher in the CL + fix group compared to the other three groups (p < .0083). CONCLUSION: Cross-linked bone blocks stabilized with collagen membrane fixation can significantly enhance GBR.

Does an untreated peri-implant dehiscence defect affect the progression of peri-implantitis?: A preclinical in vivo experimental study.

OBJECTIVE: To investigate the early impact of plaque accumulation in a buccal dehiscence defect on peri-implant marginal bone resorption. MATERIALS AND METHODS: In six male Mongrel dogs, four dental implants were placed in the posterior maxilla on both sides (two implants per side). Based on the group allocation, each implant was randomly assigned to one of the following four groups to decide whether buccal dehiscence defect was prepared and whether silk ligation was applied at 8 weeks post-implant placement for peri-implantitis induction: UC (no defect without ligation); UD (defect without ligation); LC (no defect with ligation); and LD (defect with ligation) groups. Eight weeks after disease induction, the outcomes from radiographic and histologic analyses were statistically analyzed (p < .05). RESULTS: Based on radiographs, the exposed area of implant threads was smallest in group UC (p < .0083). Based on histology, both the distances from the implant platform to the first bone-to-implant contact point and to the bone crest were significantly longer in the LD group (p < .0083). In the UD group, some spontaneous bone fill occurred from the base of the defect at 8 weeks after implant placement. The apical extension of inflammatory cell infiltrate was significantly more prominent in the LD and LC groups compared to the UC group (p < .0083). CONCLUSION: Plaque accumulated on the exposed implant surface had a negative impact on maintaining the peri-implant marginal bone level, especially when there was a dehiscence defect around the implant.

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.

Immediate loading on two adjacent single dental implants with definitive nonsplinted restorations: A proof of concept in the posterior zone.

OBJECTIVES: To evaluate clinical, clinician- and patient-reported outcomes (PROs) of two adjacent single posterior implants immediately loaded with definitive single crowns up to 1 year. Ten patients in need of two adjacent posterior single implants were included. All implants were placed applying a fully digital workflow. Definitive screw-retained single zirconia crowns were delivered within 72 h after implant placement. Clinical parameters, patient- and clinician-reported outcomes were assessed up to 1 year of follow-up. CLINICAL CONSIDERATIONS: Clinical outcomes remained stable, with no implant failures or technical and biological complications throughout the observation period. Patient satisfaction was very high at baseline (crown delivery) and remained consistently high at 6 and 12 months of follow-up. Crown insertion 3 days after implant placement was rated as an easy procedure by clinicians. CONCLUSIONS: Two adjacent single implants with immediate definitive restorations (<72 h) in the posterior region appear to be a viable and easy treatment option to shorten the overall treatment time and potentially enhancing patient satisfaction. However, randomized controlled trials are needed to confirm the advantages of this treatment protocol over a delayed loading approach. CLINICAL SIGNIFICANCE: In selected cases, immediate implant loading with definitive restorations in the posterior region appears a valuable and straightforward option to shorten the overall treatment time.

Immediate loading of definitive restorations in partially edentulous patients requiring an implant-supported prosthesis: A scoping review.

STATEMENT OF PROBLEM: Interest is growing in immediately loading definitive implant-supported prostheses. However, it appears that implant protocols are evolving faster than their scientific validation. PURPOSE: The purpose of this scoping review was to identify the current trends, feasibility, and clinical outcomes of a specific clinical loading scenario (type A), where a single definitive implant-retained restoration is delivered within 3 days. The focus question was "In partially edentulous patients requiring an implant-retained prosthesis (population), is immediate loading with a definitive restoration (concept) a viable treatment option (context)?" MATERIAL AND METHODS: An electronic search was conducted in the PubMed, CENTRAL, Scopus, Embase, and Web of Science databases. Two authors independently reviewed the studies, screened titles and abstracts, and performed full-text analysis. Cross-reference checks within the bibliography of included studies, relevant reviews, and guideline were conducted. Bibliometric information and study details were extracted. RESULTS: The search identified 2568 titles after removing duplicates. Four studies involving 91 participant and 100 implant-retained restorations were included in this scoping review. The selected articles were a randomized controlled trial (RCT), a prospective clinical study, and the remaining 2 were case series. The follow-up periods investigated ranged from 6 to 26 months. All studies evaluated marginal bone loss as a primary outcome, and only 1 implant failure was reported. Patient-reported outcome measures were favorable, and no major biological or technical complications were reported in any study. CONCLUSIONS: Immediate loading with a definitive restoration within 3 days appears to be a suitable approach in specific clinical situations.

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.

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.

Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report.

AIM: Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM). MATERIALS AND METHODS: This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. RESULTS: The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups). CONCLUSIONS: The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.

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.

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.

13-year follow-up of a randomized controlled study on zirconia and titanium abutments.

OBJECTIVES: To assess survival rates and compare technical, biological, and esthetic outcomes of customized zirconia and titanium abutments at 13 years post loading. MATERIALS AND METHODS: Initially, 22 patients with 40 implants in posterior regions were included. The sites were randomly assigned to 20 customized zirconia abutments with cemented all ceramic crowns (ACC) and 20 customized titanium abutments with cemented metal ceramic crowns (MCC). At a mean follow-up of 13.4 years, patients were examined and implants/restorations assessed for survival and technical complications, as well as biological and esthetic outcomes (pocket probing depth [PPD], bleeding on probing [BOP], plaque control record [PCR], bone level [BL], papilla index [PAP], mucosal thickness, and recession (distance of the margo mucosae [MM]/margo gingivae MG)). Descriptive analyses were performed for all outcome measures. RESULTS: Fifteen patients with 21 abutments (13 zirconia, 8 titanium) were examined at 13 years. The drop-out rate was 25% (patient level). The technical survival rate of the abutments was 100%. The survival rate on the restorative level (crowns) was 100%. The assessed biological outcomes (PPD, PCR, BOP, BL) and esthetic outcomes (MG, PAP) were similar. CONCLUSIONS: Zirconia and titanium abutments supporting single implant-borne restorations rendered a high survival rate and minimal differences in terms of technical, biological, and esthetic outcomes at 13 years of follow-up.

Group 5 ITI Consensus Report: Implant placement and loading protocols.

OBJECTIVES: Working Group 5 was convened to discuss and find consensus on the topics of implant placement and loading protocols associated with single missing teeth in the anterior maxilla (aesthetic zone). Consensus statements, clinical recommendations, patient perspectives and future research suggestions were developed and presented to the plenary for discussion and approval. MATERIALS AND METHODS: Two systematic reviews were developed and submitted prior to the conference. The group considered in detail the systematic reviews and developed statements, clinical recommendations, patient perspectives and future research suggestions based on the findings of the reviews and experience of group members. Definitive versions were developed after presentation to and discussion by the plenary. RESULTS: Five consensus statements were developed and approved from each systematic review. Twelve clinical recommendations were developed by the group based on both reviews and experience. Three patient perspectives were developed, and five suggestions made for future research. CONCLUSIONS: Based on the findings of the systematic reviews and experience of group members, the Type 1A protocol (immediate placement and immediate loading), when utilized in the anterior maxilla under favorable conditions, is considered predictable and is associated with high survival rates. The procedure is considered clinically viable and is associated with aesthetic outcomes, although surgical, technical, and biological complications can occur.

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.