A comparison of Er,Cr:YSGG laser to minimally invasive surgical technique in the treatment of intrabony defects: Twelve-month results of a multicenter, randomized, controlled study.

BACKGROUND: The purpose of this publication is to report on the 12-month clinical and radiographic results comparing the surgical use of the Er,Cr:YSGG laser (ERL) and minimally invasive surgical technique (MIST) for the treatment of intrabony defects in subjects with generalized periodontitis stage III, grade B. METHODS: Fifty-three adult subjects (29 females and 24 males; 19-73 years) with 79 intrabony defects were randomized following scaling and root planing (SRP) to receive ERL monotherapy (n = 27) or MIST (n = 26). Fifty subjects completed the study. Recession (REC), probing depth (PD), clinical attachment level (CAL), treatment time, and standardized radiographs were assessed and compared for each treatment group. Clinical measurements were recorded at baseline, 4-6 weeks following SRP, and 6 and 12 months following surgical therapy. Radiographic results were compared to baseline at 6 and 12 months following surgical therapy. RESULTS: The following primary and secondary outcome variables were non-inferior with the following margins: CAL with a non-inferiority margin of 0.7 mm (p = 0.05), PD with a non-inferiority margin of 0.7 mm (p = 0.05), and REC with a non-inferiority margin of 0.4 mm (p = 0.05). Standardized radiographs suggest similar bone fill of 1.14 ± 1.73 mm for MIST and 1.12 ± 1.52 mm for ERL. CONCLUSIONS: This is the first multicenter, randomized, masked, and controlled study demonstrating the ERL is not inferior to MIST at 12 months in terms of clinical outcomes and similar to MIST in terms of radiographic bone fill for the surgical treatment of intrabony defects.

Harvest graft substitute for soft tissue volume augmentation around existing implants: A randomized, controlled and blinded multicenter trial.

BACKGROUND: Using a single-blind, randomized, controlled, multicenter, practice-based clinical trial, a volume-stable collagen matrix (VCMX) was compared with connective tissue graft (CTG) for soft tissue augmentation around existing dental implants. METHODS: Sixty patients (31 VCMX and 31 CTG) were included. The primary outcome was a soft tissue thickness change 3 mm below the gingival margin (GM). Secondary outcomes included clinical measures, such as keratinized tissue widths (KTw), probing pocket depths, and pink esthetic scores, and patient-reported outcomes (PRO). RESULTS: There were no significant differences between test and control patient demographics or clinical measures throughout the 1-year study. VCMX "grafts" were by design larger than CTG, and surgery time was less (27% less, p = 0.0005). Three millimeters below the GM (primary endpoint), tissue thickness increase was noninferior for VCMX compared with CTG (0.93 ± 0.80 mm vs. 1.10 ± 0.51 mm, respectively), inferior (by 0.25 mm) at 1 mm, and noninferior at 5 mm. Postoperative pain was significantly less for VCMX patients (p < 0.0001), but all other PRO measures, including esthetics and satisfaction, improved similarly for both therapies. CONCLUSIONS: Given the inclusion criteria for this study, namely soft tissue augmentation around existing implants with some evidence of KTw and minimal recession, VCMX provided soft tissue thickness and volume increases similar (noninferior) to CTG. Clinical measures and PRO were similar between therapies-site sensitivity and esthetics improved similarly for both therapies-but surgery time and pain following surgery were significantly less for VCMX.

Diagnostic reproducibility of the 2018 Classification of Gingival Recession Defects and Gingival Phenotype: A multicenter inter- and intra-examiner agreement study.

BACKGROUND: The aim of this study was to investigate the inter- and intra-examiner agreement among international experts on the diagnosis of gingival recession defects using the 2018 Classification of Gingival Recession Defects and Gingival Phenotype as proposed in the 2017 World Workshop. METHODS: Standardized intraoral photographs from 28 gingival recession defects were evaluated twice by 16 expert periodontists. Recession type (RT), recession depth (RD), keratinized tissue width (KTW), gingival thickness (GT), detectability of the cemento-enamel junction (CEJ), and presence of root steps (RS) were recorded and used for the analysis. Intra- and inter-examiner agreements were calculated for individual variables and for the overall classification. Intraclass correlation coefficient with 95% CI was used for RD and KTW; Kappa with 95% CI was used for GT, CEJ, and RS; quadratic weighted Kappa with 95% CI was used for RT. RESULTS: Overall intra- and inter-examiner agreements were highest for KTW (0.95 and 0.90), lowest for GT (0.75 and 0.41), with the other variables in between (RD: 0.93 and 0.68, RS: 0.87 and 0.65, RT: 0.79 and 0.64, CEJ: 0.75 and 0.57). Overall intra- and inter-examiner agreements for the matrix were 62% and 28%, respectively. Significant effects existed between one variable's measurement and other variables' agreements. CONCLUSIONS: The 2018 Classification of Gingival Recession Defects and Gingival Phenotype is clinically reproducible within the examiners, and when the variables forming the matrix are analyzed individually. The between-examiner agreement for the complete matrix showed lower reproducibility. The agreement was highest for KTW and RD, and least for GT.

The treatment of multiple gingival recession defects with connective tissue grafting and enamel matrix derivative in a private practice setting: Two case reports.

BACKGROUND: Dentofacial esthetics has become a mainstay treatment in periodontics. For a periodontal private practice to succeed in a referral-based environment, predictability and stability in treatment results are crucial. The scientific literature provides a guide to successfully treating multiple recession defects with non-carious cervical lesions and lingual recession. These case reports show how the use of biologic mediators, proper case selection, and proper surgical technique may provide a better treatment outcome for our patients. METHODS: Two patients with multiple gingival recession defects were treated with autogenous tissue grafting in conjunction with the application of enamel matrix derivative (EMD) to attempt root coverage. Based on the Cairo classification, the recession defects were classified as type I in the maxillary buccal and lingual recession in the mandibular anterior. There were areas of no attached gingiva, loss of enamel, and the presence of non-carious cervical lesions. RESULTS: At 3-month post-treatment in case #1 and 6-month post-treatment in case #2, satisfactory esthetic results for the patients and clinician were achieved. These short-term follow-ups were favorable for root coverage and soft tissue healing, especially at the 1-week visit. There was noticeably less edema and erythema. Additionally, dental hypersensitivity was no longer reported for both patients. CONCLUSION: By using biologic mediators, such as an EMD combined with connective tissue grafting, both multiple recession defects with non-carious cervical lesions, and lingual recession cases, can be treated successfully in a private practice setting. Using an EMD provides no additional risks to patients, may result in faster healing, and would afford stability of long-term success by influencing true periodontal regeneration.

Efficacy of a harvest graft substitute for recession coverage and soft tissue volume augmentation: A randomized controlled trial.

BACKGROUND: The autogenous connective tissue graft (CTG) with coronally advanced flap (CTG+CAF) is the "gold standard" for recession defect coverage; however, researchers continue to pursue lower morbidity, more convenient and unlimited supply harvest graft substitutes, including those that could provide soft tissue volume augmentation. METHODS: A randomized, controlled, double-masked comparison of a volume-stable collagen matrix (VCMX) versus CTG was conducted at four clinical investigation sites. Single, contralateral, within patient matched-pair, RT1 recession defects were treated with VCMX+CAF (test) and CTG+CAF (control). The primary efficacy end point was percent root coverage at 6 months. Secondary efficacy end points included clinical measures such as soft tissue volume, attachment level, and keratinized tissue width. Patient-reported outcomes included measures such as discomfort, esthetics, and overall satisfaction; 6-month end point results were followed for 1 year. RESULTS: Thirty patients received control and test therapies, and all patients were available for follow-up measures. Average percent root coverage for CTG+CAF was 90.5% ± 14.87% versus 70.7% ± 28.26% for VCMX+CAF, P <0.0001. Both therapies produced significant soft tissue volume increases (84.8 ± 47.43 mm3 control versus 48.90 ± 35.58 mm3 test, P = 0.0006). The test, harvest graft substitute produced less postoperative pain and was preferred by patients at the 6-month end point. All other end point measures were not significantly different. CONCLUSIONS: VCMX+CAF root coverage was inferior to CTG+CAF but produced less morbidity and was preferred by patients. Case/patient selection and surgical technique appear key to achieving successful results with the harvest graft alternative.

A Prospective, Randomized, Controlled, Multicenter Evaluation of Extraction Socket Management Comparing a Wound Dressing and a Soft Tissue Substitute.

Postextraction bone grafting and implant placement help preserve alveolar bone volume. Collagen wound dressings and soft tissue graft substitutes may help protect extraction socket bone grafts and provide better gingival contours. This randomized, controlled, multicenter, and double-blinded study was conducted to compare a control (wound dressing) and a test (soft tissue graft) substitute in nearly intact extraction sockets. Both test and control sockets were grafted with a xenogeneic bone graft. Graft containment, extraction socket soft tissue gap closure, gingival contour, and gingival thickness were examined over 16 weeks, at which time implants were placed. Healing was uneventful for both groups, and there was no significant difference (P < .05) between the times required to close the extraction socket soft tissue gap (~80% of sites closed by 8 weeks). Bone grafts were covered and contained longer in the test group (~4 weeks vs ~2 weeks), with less contour disruption out to 4 weeks; however, at implant placement, soft tissue contours in both groups were comparable, and soft tissue thicknesses were not significantly different.

American Academy of Periodontology best evidence consensus statement on the use of biologics in clinical practice.

A biologic is a therapeutic agent with biological activity that is administered to achieve an enhanced regenerative or reparative effect. The use of biologics has progressively become a core component of contemporary periodontal practice. However, some questions remain about their safety, indications, and effectiveness in specific clinical scenarios. Given their availability for routine clinical use and the existing amount of related evidence, the goal of this American Academy of Periodontology (AAP) best evidence consensus (BEC) was to provide a state-of-the-art, evidence-based perspective on the therapeutic application of autologous blood-derived products (ABPs), enamel matrix derivative (EMD), recombinant human platelet-derived growth factor BB (rhPDGF-BB), and recombinant human bone morphogenetic protein 2 (rhBMP-2). A panel of experts with extensive knowledge on the science and clinical application of biologics was convened. Three systematic reviews covering the areas of periodontal plastic surgery, treatment of infrabony defects, and alveolar ridge preservation/reconstruction and implant site development were conducted a priori and provided the foundation for the deliberations. The expert panel debated the merits of published data and exchanged experiential information to formulate evidence-based consensus statements and recommendations for clinical practice and future research. Based on an analysis of the current evidence and expert opinion, the panel concluded that the appropriate use of biologics in periodontal practice is generally safe and provides added benefits to conventional treatment approaches. However, therapeutic benefits and risks range based on the specific biologics used as well as patient-related local and systemic factors. Given the limited evidence available for some indications (e.g., gingival augmentation therapy, alveolar ridge preservation/reconstruction, and implant site development), future clinical studies that can expand the knowledge base on the clinical use of biologics in periodontal practice are warranted.

Randomized, controlled, clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation: A 6- to 8-year follow-up.

BACKGROUND: The purpose of this follow up study was to determine if a xenogeneic collagen matrix (CMX) is as effective as free gingival graft (FGG) in preventing further recession 6+ years following vestibuloplasty. METHODS: This study was a single-blind (examiner), randomized, controlled, split-mouth study of 30 subjects with insufficient zones of KT (< 2 mm), associated with at least two, paired teeth. The study utilized a within subject treatment comparison to examine non-inferiority according to primary and secondary endpoints 6+ years after therapy. The original study primary efficacy endpoint was keratinized tissue width (KTw); however, in this report, prevention of recession (Rec) was also examined, along with traditional, secondary clinical measures, histopathology of mucosal biopsies and exploratory, patient reported outcomes (PROs) for pain and satisfaction. RESULTS: A total of 23 of the 30 original, study patients were available for 6 to 8-year postoperative assessment, and these patients were representative of the original patient population. For preventing further Rec, CMX was not inferior to FGG (ΔRec = -0.07 ± 1.26 mm for CMX and -0.17 ± 0.78 mm for FGG, P = 0.710). There were no adverse results observed, and histological assessment indicated normal, keratinized gingiva for both therapies. Tissue texture and color match to surrounding, native tissues were significantly better for CMX, and patients preferred CMX over FGG therapy. CONCLUSIONS: CMX appears to be a suitable substitute for FGG 6+ years after therapy.

Comparison of Er,Cr:YSGG laser to minimally invasive surgical technique in the treatment of intrabony defects: Six-month results of a multicenter, randomized, controlled study.

BACKGROUND: The purpose of this publication is to report on the six-month clinical results and patient-reported outcomes (PROs) comparing the surgical use of the erbium, chromium-doped: yttrium, scandium, gallium, and garnet (Er,Cr:YSGG) laser (ERL) and minimally invasive surgical technique (MIST) for the treatment of intrabony defects in subjects with generalized periodontitis stage III, grade B. METHODS: Fifty-three adults (29 females and 24 males; aged 19 to 73 years) with 79 intrabony defects were randomized following scaling and root planing (SRP) to receive ERL monotherapy (n = 27) or MIST (n = 26). Recession, probing depth (PD), clinical attachment level (CAL), treatment time, and PROs were assessed and compared for each treatment group. Clinical measurements were recorded at baseline, 4 to 6 weeks following SRP, and 6 months following surgical therapy. RESULTS: The following primary and secondary outcome variables were non-inferior with the following margins: CAL with a non-inferiority margin of 0.6 mm (p = 0.05), PD with a non-inferiority margin of 0.5 mm (p = 0.05). Recession with a non-inferiority margin of 0.4 mm (p = 0.05). Faster procedure times were found for ERL (16.39 ± 6.21 minutes) versus MIST (20.17 ± 5.62 minutes), p = 0.0002. In the first 2 to 3 days of post-therapeutic diary outcomes, subjects reported less bruising, facial swelling, and use of ice pack for the ERL group. CONCLUSIONS: This is the first multicenter, randomized, masked, and controlled study demonstrating the ERL is not inferior to MIST in terms of clinical outcomes but is superior in PROs for the surgical treatment of intrabony defects.

A Novel Parallel-Walled Dental Implant with a Self-Tapping Apex, Conical Connection, and Platform Shifting: Short-Term Results from a Retrospective Multicenter Clinical Study.

This multicenter retrospective study assessed clinical and radiographic outcomes of 686 parallel-walled conical-connection implants consecutively placed in 281 partially and fully edentulous patients. Implants were placed in healed and postextraction sites and subjected to immediate, early, or delayed loading. With a mean follow-up of 10 ± 6.7 months, the implant survival rate was 97.7%, while mean marginal bone loss was 0.7 ± 1.5 mm between implant placement and 1 year (n = 290 implants) and 0.1 ± 0.6 mm between 1 and 2 years (n = 72 implants). Advanced patient age and longer implants were associated with fewer implant failures, while different crestal positions at implant placement were not associated with differences in implant survival or changes in marginal bone level over time.

In Vitro Surface Testing Methods for Dental Implants-Interpretation and Clinical Relevance: A Review.

More than 2,000 dental implant options are estimated to be available for any given clinical situation. Because many implants have claims that are substantiated mainly on the basis of in vitro studies, it is prudent for clinicians to understand the interpretation of such studies and possible clinical relevance. In vitro tests can be segregated as surface analysis tests and mechanical assessment tests. With a wide variation of methodologies used and results achieved by different implant manufacturers, practitioners may find it difficult to judge the clinical significance of in vitro tests. This article provides an overview, including limitations, of the in vitro implant analysis tests implant companies routinely perform, ranging from older methods involving mechanical testing and surface microscopy to more recent tests such as atomic force microscopy (AFM) studies and gene expression tests, to assist clinicians when choosing an implant system. Having identified the limitations of in vitro testing methods, the current evidence indicates that scanning electron microscopy may be useful in providing insight on the role of implant surface topography. AFM, single cell tests, 3D imaging, and gene expression tests could be useful for assessment of cellular and physio-biochemical properties. 3D finite element analysis may help in the evaluation of mechanical properties of dental implants. Clinicians are encouraged to correlate the findings of in vitro tests with robust animal histologic studies and well-designed, high-quality clinical research to ascertain optimum clinical results.

Implant Placement Under Dynamic Navigation Using Trace Registration: Case Presentations.

Trace registration is a new, alternative registration method for dynamic navigation implant surgery that eliminates the need for an artificial fiducial marker and stent to be present in the CBCT scan, substituting it with other high-contrast landmarks such as teeth, implants, or abutments. Clinical advantages include a streamlined, simplified workflow with fewer opportunities for error; elimination of presurgical steps associated with stent fabrication and imaging; and reduction in radiation risk. Sufficient high-contrast intraoral structures are a prerequisite for using this technique. This case series presents the trace registration protocol and workflow and reports on cases that demonstrate the application of this technology, including postoperative placement accuracy evaluation.

Histologic Evaluation of rhBMP-2 in an Extraction Site Model in the Esthetic Zone: A Series of 16 Cases Preparing for Implant Placement.

Growth factors have been used in numerous oral applications to aid in bone formation after tooth extraction. Bone morphogenetic proteins (BMPs) are members of the transforming growth factor-b superfamily and are involved in the differentiation of pluripotent mesenchymal cells, leading to new bone formation through osteoblastic induction. This study examined histologic wound healing following extraction and ridge preservation using recombinant human BMP-2 (rhBMP-2) and a collagen sponge. Formation of new vital bone was seen, suggesting that this material is a viable option for ridge preservation in preparation for implant placement.

Growth factor-mediated treatment of recession defects: a randomized controlled trial and histologic and microcomputed tomography examination.

BACKGROUND: The primary aims of this two-part prospective study were: 1) to compare the safety and efficacy of beta-tricalcium phosphate (beta-TCP) + 0.3 mg/ml recombinant human platelet-derived growth factor-BB (rhPDGF-BB) with a bioabsorbable collagen wound-healing dressing and a coronally advanced flap (CAF) to a subepithelial connective tissue graft (CTG) in combination with a CAF in subjects with gingival recession defects using a randomized, controlled, split-mouth design; and 2) to compare, through histologic and microcomputed tomography (micro-CT) examination, the periodontal regenerative potential of these two therapies in surgically created gingival recession defects in restoring missing cementum, periodontal ligament (PDL), and supporting alveolar bone. METHODS: In the randomized controlled trial (RCT), 30 patients with Miller Class II buccal gingival recession, > or = 3 mm deep and > or = 3 mm wide in contralateral quadrants of the same jaw were treated and followed for 6 months. Using a split-mouth design with similar bilateral recession defects, test sites were treated with 0.3 mg/ml rhPDGF-BB + beta-TCP + bioabsorbable collagen wound-healing dressing; contralateral control sites were treated with a CTG, each in combination with a CAF. In the histologic/micro-CT study segment, recession defects were created in six teeth, each requiring extraction for orthodontic therapy. These defects were created with a recession depth > or = 3 mm, the osseous crest 2 to 3 mm apical to the gingival margin, and with 2 to 3 mm of keratinized tissue. The defects were treated with a CTG (control) or rhPDGF-BB + beta-TCP + wound-healing dressing (test), plus CAF. Nine months after surgical correction, en bloc resections were obtained and examined histologically and with micro-CT. RESULTS: In the RCT, test and control treatments demonstrated clinically significant improvements from baseline through month 6. Statistically significant results favoring the CTG were found in recession depth reduction (-2.9 + 0.5 mm, test; -3.3 + 0.6 mm, control; P = 0.009), root coverage (90.8%, test; 98.6%, control; P = 0.013), and -3.9 +/- 0.7 mm, control, -3.3 +/- 1.3 mm, test, recession width reduction (P = 0.035), whereas mid-buccal probing depth (PD) and PD reduction (PDR) reduction favored the test group (1.4 +/- 0.4 mm, test; 1.8 +/- 0.1 mm, control; P < 0.001 PD and -0.0 mm test; +0.4 mm control PDR). For all other parameters, the two treatments were statistically equivalent, including increases in keratinized tissue, esthetic results, and subject satisfaction. In the histologic/micro-CT portion, all four sites treated with rhPDGF-BB + beta-TCP showed evidence of regeneration of cementum, PDL with inserting connective tissue fibers, and supporting alveolar bone, whereas neither CTG-treated site exhibited any signs of periodontal regeneration. CONCLUSIONS: CTG and rhPDGF-BB + beta-TCP + wound-healing dressing are effective treatment modalities for clinically correcting gingival recession defects. In addition, the current study demonstrated that regeneration of the periodontium in gingival recession defects was possible through a growth factor-mediated approach.

A pilot study to evaluate a tissue-engineered bilayered cell therapy as an alternative to tissue from the palate.

BACKGROUND: This study evaluated the safety and effectiveness of a tissue-engineered skin product composed of viable neonatal keratinocytes and fibroblasts and compared it to a free gingival graft (FGG) in a procedure to enhance keratinized tissue (KT) and wound healing around teeth that do not require root coverage. METHODS: Twenty-five subjects were enrolled who had at least two non-adjacent teeth in contralateral quadrants exhibiting an insufficient zone of attached gingiva requiring soft tissue grafting where root coverage was not desired. One tooth was randomized to receive an FGG, and the other was randomized to receive bilayered cell therapy (BCT). The amount of KT was measured at baseline and 3 and 6 months, and the texture and color of the grafted tissue were compared to the surrounding tissue at months 1, 3, and 6. A questionnaire was used to determine subject preference at 6 months. Biopsies and persistence studies were performed on a subset of the subjects. RESULTS: The FGG generated statistically significantly (P <0.001) more KT than the test device (BCT) (4.5 +/- 0.80 mm versus 2.4 +/- 1.02 mm); no significant difference in recession or clinical attachment level was detected between treatment groups (P = 0.212 and P = 0.448, respectively); and no significant differences were detected at any time point for bleeding on probing (BOP), resistance to muscle pull, or inflammation. The BCT group had significantly better color and texture match with surrounding tissue (P <0.001), and subject preference was significantly greater for the BCT group (P = 0.041). No device-related adverse events or safety issues occurred during the course of the study. CONCLUSIONS: The tissue-engineered graft BCT was safe and capable of generating de novo KT without the morbidity and potential clinical difficulties associated with donor-site surgery. The amount of KT generated with FGG was greater than generated with BCT; however, 24 of 25 test sites demonstrated an increase in KT at 6 months, with more than three-quarters of the sites yielding > or =2 mm bands of KT.

Pink Esthetic Score Outcomes Around Three Implant-Abutment Configurations: 3-Year Results.

PURPOSE: To evaluate the influence that three different implant-abutment interface designs had on peri-implant mucosal outcomes as assessed by the pink esthetic score (PES) 3 years after delayed implant placement and immediate provisionalization. MATERIALS AND METHODS: Adult subjects (n = 141) requiring replacement of a bounded single tooth in the anterior maxilla as well as first premolar sites were randomized to receive one of three unique implant-abutment interface designs (conical interface [CI]; flat-to-flat interface [FI]; or platform-switch interface [PS]). Treatment included immediate provisionalization with prefabricated titanium abutments, followed by custom computer-aided design/computer-aided manufacturing (CAD/CAM) zirconia abutments and cement-retained, all-ceramic crowns delivered after 12 weeks. Bilateral (anterior sites) or unilateral (premolar sites) digital clinical photographs were made at 1, 3, 6, 12, 24, and 36 months post-implant placement. Five calibrated faculty evaluators who previously scored the 1-year PES image dataset scored the 24- and 36-month photographs using a digital, cloud-based tablet interface. RESULTS: Six hundred ten clinical photographs were evaluated, resulting in a total of 3,050 sum PES values and 21,350 individual PES values. Faculty evaluator intrarater and interrater reliability were found to be "substantial," with intraclass correlation coefficient (ICC) values of 0.76 and 0.77, respectively. All three implant-abutment interface groups demonstrated acceptable esthetics at 3 years (mean sum PES = 10.1 ± 1.9, 4.0 to 13.2), with no single group demonstrating significantly greater mean sum PES values than another at the 3-year follow-up or at any recall interval in between. CONCLUSION: No significant differences were observed in mean sum PES scores for subjects randomized to one of three different implant-abutment interface geometries. Within the limitations of this study thus far, the first 6 months following definitive prosthesis delivery appear to still be the most significant with regard to improvement in PES outcomes for all three treatment groups.

A randomized, double-blind, placebo-controlled study to determine the safety and efficacy of cultured and expanded autologous fibroblast injections for the treatment of interdental papillary insufficiency associated with the papilla priming procedure.

BACKGROUND: The aim of this study was to assess the efficacy and safety of using autologous fibroblast injections following a minimally invasive papilla priming procedure to augment open interproximal spaces. METHODS: Twenty-one patients with open interproximal spaces were enrolled in this study, with 20 patients retained to study completion. Two primary sites were selected and randomized to receive autologous fibroblast injections or placebo injections beginning 1 week following the papilla priming procedure; two additional injections were performed 7 to 14 days following the initial injections. Up to seven additional sites could be treated per patient, and the analyses were conducted for the primary and secondary sites. The primary efficacy parameter was the percentage change in papillary height of the primary treatment areas from baseline to the 4-month visit, as measured by a periodontal probe from the base of the contact area to the tip of the interproximal papilla. Digital image analysis and diagnostic models were used to confirm clinical measurements. A visual analog scale (VAS) was used by the examiner and subject to assess the defect change from baseline to 2, 3, and 4 months. Tissue texture also was assessed by the examiner. RESULTS: The primary efficacy analysis failed to show a significant treatment effect at 4 months, but the treatment areas showed a statistically significant mean percentage increase from baseline in papillary height (P = 0.0067; signed-rank test) at 2 months. The difference between test and placebo sites in papillary height at 2 months approached statistical significance (P = 0.0730), suggesting that the test treatment was superior to the placebo treatment. The examiner and subject VASs were statistically significantly different from baseline for both treatment groups, and the VAS was superior for the test sites over the placebo. Based on safety data, the test treatment was deemed safe. CONCLUSIONS: This early-phase study using cell transplantation of autologous cultured and expanded fibroblasts following a papilla priming procedure suggests that the treatment is safe and may be efficacious for treating papillary insufficiency, especially in the early phases (2 months) of healing. The analysis of the investigator and subject VAS assessments indicates that the test treatment was superior to the placebo treatment. The finite measurement required to detect a change creates a problem that needs to be addressed in future studies.

Retrospective Study to Determine Patient Satisfaction of Immediately Placed and Provisionalized Implants in the Esthetic Zone From a US Private-Practice Research Network.

BACKGROUND: Immediately placed/immediately restored dental implants in the esthetic zone are judged by not only their functional success but also the appearance and acceptance of the restorative outcome. The purpose of this study was to retrospectively evaluate in a private-practice setting the satisfaction of both patients and doctors regarding immediately placed/immediately restored implants in the esthetic zone. METHODS: The author group consists of nine board-certified periodontists. Each private practice contributed to the patient population of this study through a primarily referral-based source. In a 6-month period, practices evaluated patients who were candidates for dental implant replacement with teeth Nos. 5 through 12 scheduled for extraction. All patients received informed consent and were asked if their data could be used with a visual analog scale (VAS) they graded. Pretreatment and 6-month post-final restoration loading was compared for statistically significant changes in reference to crestal bone changes, papilla index score (PIS), facial gingival margin stability (FGMS), and investigator/patient esthetic evaluations using a VAS. RESULTS: Thirty-five patients were included in the study with a total of 35 implants placed and 32 restored with a final restoration. Implants were followed for an average of 15.4 months prior to reporting. A total of three failures were encountered. The PIS resulted in an average score of 2.7. VAS resulted in an average score of 9.3 by the surgeons and 9.5 by the patients. The FGMS accounted for 76% of the implants with no change, 15% demonstrating recession, and 9% demonstrating coronal migration. CONCLUSIONS: Immediately placed and immediately temporized implants in the esthetic zone demonstrated a successful outcome that was highly acceptable to patients in private-practice settings from a diverse group of private periodontal practices.

American Academy of Periodontology Best Evidence Consensus Statement on Selected Oral Applications for Cone-Beam Computed Tomography.

BACKGROUND: The American Academy of Periodontology (AAP) recently embarked on a Best Evidence Consensus (BEC) model of scientific inquiry to address questions of clinical importance in periodontology for which there is insufficient evidence to arrive at a definitive conclusion. This review addresses oral indications for use of cone-beam computed tomography (CBCT). METHODS: To develop the BEC, the AAP convened a panel of experts with knowledge of CBCT and substantial experience in applying CBCT to a broad range of clinical scenarios that involve critical structures in the oral cavity. The panel examined a clinical scenario or treatment decision that would likely benefit from additional evidence and interpretation of evidence, performed a systematic review on the individual, debated the merits of published data and experiential information, developed a consensus report, and provided a clinical bottom line based on the best evidence available. RESULTS: This BEC addressed the potential value and limitations of CBCT relative to specific applications in the management of patients requiring or being considered for the following clinical therapies: 1) placement of dental implants; 2) interdisciplinary dentofacial therapy involving orthodontic tooth movement in the management of malocclusion with associated risk on the supporting periodontal tissues (namely, dentoalveolar bone); and 3) management of periodontitis. CONCLUSION: For each specific question addressed, there is a critical mass of evidence, but insufficient evidence to support broad conclusions or definitive clinical practice guidelines.