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.

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.

Efficacy and safety of P11-4 for the treatment of periodontal defects in dogs.

OBJECTIVES: This study's aim was to investigate the safety and performance of a self-assembling peptide matrix (SAPM) P11-4 for the treatment of periodontal disease in a controlled pre-clinical study. MATERIALS AND METHODS: Acute buccal bony dehiscence defects (LxW: 5 × 3 mm) were surgically created on the distal root of four teeth on one mandible side of 7 beagle dogs followed by another identical surgery 8 weeks later on the contralateral side. SAPM P11-4 (with and without root conditioning with 24% EDTA (T1, T2)), Emdogain® (C) and a sham intervention (S) were randomly applied on the four defects at each time point. Four weeks after the second surgery and treatment, the animals were sacrificed, the mandibles measured by micro-computed tomography (µ-CT) and sections of the tissue were stained and evaluated histologically. RESULTS: Clinically and histologically, no safety concerns or pathological issues due to the treatments were observed in any of the study groups at any time point. All groups showed overall similar results after 4 and 12 weeks of healing regarding new cementum, functionality of newly formed periodontal ligament and recovery of height and volume of the new alveolar bone and mineral density. CONCLUSION: A controlled clinical study in humans should be performed in a next step as no adverse effects or safety issues, which might affect clinical usage of the product, were observed. CLINICAL RELEVANCE: The synthetic SAPM P11-4 may offer an alternative to the animal-derived product Emdogain® in the future.

Bone augmentation at peri-implant dehiscence defects comparing a synthetic polyethylene glycol hydrogel matrix vs. standard guided bone regeneration techniques.

OBJECTIVES: The aim of the study was to test whether or not the use of a polyethylene glycol (PEG) hydrogel with or without the addition of an arginylglycylaspartic acid (RGD) sequence applied as a matrix in combination with hydroxyapatite/tricalciumphosphate (HA/TCP) results in similar peri-implant bone regeneration as traditional guided bone regeneration procedures. MATERIAL AND METHODS: In 12 beagle dogs, implant placement and peri-implant bone regeneration were performed 2 months after tooth extraction in the maxilla. Two standardized box-shaped defects were bilaterally created, and dental implants were placed in the center of the defects with a dehiscence of 4 mm. Four treatment modalities were randomly applied: i)HA/TCP mixed with a synthetic PEG hydrogel, ii)HA/TCP mixed with a synthetic PEG hydrogel supplemented with an RGD sequence, iii)HA/TCP covered with a native collagen membrane (CM), iv)and no bone augmentation (empty). After a healing period of 8 or 16 weeks, micro-CT and histological analyses were performed. RESULTS: Histomorphometric analysis revealed a greater relative augmented area for groups with bone augmentation (43.3%-53.9% at 8 weeks, 31.2%-42.8% at 16 weeks) compared to empty controls (22.9% at 8 weeks, 1.1% at 16 weeks). The median amount of newly formed bone was greatest in group CM at both time-points. Regarding the first bone-to-implant contact, CM was statistically significantly superior to all other groups at 8 weeks. CONCLUSIONS: Bone can partially be regenerated at peri-implant buccal dehiscence defects using traditional guided bone regeneration techniques. The use of a PEG hydrogel applied as a matrix mixed with a synthetic bone substitute material might lack a sufficient stability over time for this kind of defect.

Long-term clinical, technical, and esthetic outcomes of all-ceramic vs. titanium abutments on implant supporting single-tooth reconstructions after at least 5 years.

AIM: The aim of this prospective cohort study was to evaluate clinical, radiographic, technical, esthetic, and patient-centered outcomes of implants using two different restoration materials after 5-9 years. MATERIALS AND METHODS: The study included 28 patients (test group: 13 patients with all-ceramic crowns on aluminum oxide-based abutments; control group: 15 patients with metal abutments on porcelain-fused-to-metal crowns). Evaluation of patient satisfaction, clinical (periodontal probing depth, bleeding on probing, plaque index, mucosal recession, and width of keratinized mucosa), esthetical (papilla index, clinical crown length), technical (loss of retention, marginal adaptation, chipping of ceramic, anatomical shape, occlusal wear, color match), and radiological parameters were assessed. The statistical analyses included comparison of all-ceramic vs. metal abutments and between the groups using Mann-Whitney U-tests. For esthetic parameters, changes over time were assessed using Friedman test and post hoc Wilcoxon test of all complete cases. RESULTS: The survival rate of the restoration was 100% in both groups. Patient's satisfaction revealed 9.7 on the visual analog scale. A low satisfaction correlated with low ratings in color or anatomical shape. The mucosal recession in the test group was less than that in the control group. An increase in distal papilla height in the year 0 to 1, and a decrease from year 1 to 8, was detected. Sites, which received a soft tissue graft, revealed stable papillae over the observation period. Clinical crown length showed higher values in the control group. CONCLUSIONS: Within the limitations of the study, it can be concluded that all-ceramic restorations reveal a high survival rate of 100% and show no difference to metal after a mean observation period of 7.2 years.

Evaluation of parathyroid hormone bound to a synthetic matrix for guided bone regeneration around dental implants: a histomorphometric study in dogs.

BACKGROUND: A polyethylene glycol (PEG)-based hydrogel matrix covalently bound to a 35-amino acid peptide of parathyroid hormone cystein-PTH 1-34 (cys-PTH 1-34) was shown to enhance bone regeneration around implants. The aim of this study is to test if the addition of an integrin-receptor-binding arginine-glycine-aspartic acid (RGD)-containing peptide at early healing time points improves the performance of the PEG matrix supplemented with cys-PTH 1-34 (PTH) when applied in acute defects around implants at early healing time points (2 and 4 weeks). METHODS: Six dogs received 48 implants. Each side of the mandible was randomly assigned for implantation at day 0 or 2 weeks. A circumferential critical-size defect was created at each site before implantation. Sites were randomly assigned to one of four groups: 1) PEG alone (PEG group), 2) PEG plus RGD (PEG/RGD group), 3) PEG plus PTH (PEG/PTH group), and 4) PEG plus RGD plus PTH (PEG/RGD/PTH group). Dogs were sacrificed 2 weeks after the second surgery, and specimens were obtained for histologic analysis. For the statistical analysis, mixed linear regression with repeated measurements was used, and a Dunnett-Hsu adjustment was made for multiple comparisons. RESULTS: At 2 weeks, the percentages of new bone formation within the defect were 12.43% for the PEG group, 15.95% for the PEG/RGD group, 15.32% for the PEG/PTH group, and 16.60% for the PEG/RGD/PTH group. At 4 weeks, the percentages of new bone formation within the defect were 30.01% for the PEG group, 27.90% for the PEG/RGD group, 29.89% for the PEG/PTH group, and 27.58% for the PEG/RGD/PTH group. A marginally significant difference (PEG/RGD/PTH group versus PEG group; P = 0.055) was found at 2 weeks but not at 4 weeks. The highest percentage of bone-to-implant contact (BIC) in the defect site at 2 weeks was observed for the PEG/RGD group (8.57%). The BIC after 4 weeks of healing ranged from 11.54% (PEG/RGD/PTH group) to 16.61% (PEG group). No statistically significant differences were observed in BIC. CONCLUSIONS: The effect of binding PTH covalently to a synthetic, RGD-modified PEG hydrogel marginally significantly improved bone formation at 2 weeks of healing compared to the use of PEG alone. Bone regeneration within the defects increased in all groups at week 4 of healing without statistically significant differences.

The effect of all-ceramic and porcelain-fused-to-metal restorations on marginal peri-implant soft tissue color: a randomized controlled clinical trial.

The aim of this study was to test the color-change effect of all-ceramic restorations compared with porcelain-fused-to-metal (PFM) restorations on marginal peri-implant soft tissue. Thirty patients were randomly divided into 2 groups of 15 subjects each. The all-ceramic group received all-ceramic crowns on aluminum oxide-based abutments, while the PFM group received crowns on titanium or gold abutments. A reflectance spectrophotometer was used to measure the color difference (deltaE(Implant)) between the midfacial peri-implant mucosa before and after restoration insertion. The color difference (deltaE(Tooth-implant)) between the midfacial peri-implant mucosa and the gingival margin of the corresponding neighboring tooth was tested. The mucosal thickness was measured midfacially around the implant (MT(Implant)) and neighboring tooth (MT(Tooth)). deltaE(Implant) values were similar for the all-ceramic (7.4 +/- 2.7) and PFM groups (7.6 +/- 2.8). The all-ceramic group induced significantly less visible mucosal color change (3.4 +/- 1.4) compared to the PFM group (5.2 +/- 2.3). The MT(Implant) value of the all-ceramic group was 3.4 +/- 0.8 mm, while that of the PFM group was 2.9 +/- 0.9 mm, which was not significantly different. Significant differences were found when comparing MT(Implant) (3.1 +/- 0.9) and MT(Tooth) (1.2 +/- 0.3) values for test and control groups. All-ceramic restorations revealed a better color match to the neighboring teeth than PFM restorations.