Bone preservation or augmentation simultaneous with or prior to dental implant placement: A systematic review of outcomes and outcome measures used in clinical trials in the last 10 years.

AIM: To evaluate outcome measures and methods of assessment in clinical studies on bone augmentation/preservation procedures for the placement of dental implants. MATERIALS AND METHODS: A systematic search was performed on three databases from January 2011 to April 2021 to identify clinical studies reporting on any type of bone augmentation/preservation procedure. The outcomes that have been used to assess efficacy or performance in each study were registered and assigned to different domains (group of outcomes). The review followed the Preferred Reporting Items for Systematic Review and Meta-Analyses statement. RESULTS: Seven-hundred and eighty-three publications were included. Only 81.8% of the papers had a clear definition of their primary outcome. The rate of complications (59.3%), implant survival (58.2%), 3D radiographic bone gain/change (30%), marginal bone level (MBL; 29%), and histological outcomes (25.5%) were the most frequently reported outcome domains. The most commonly used primary outcome was 3D radiographic bone gain/change (25.8%), followed by implant survival (13.0%). Patient-reported outcome measures (PROMs) were reported in 15.7% of studies. Differences in the reported outcomes were observed among different types of bone preservation/augmentation interventions (i.e., alveolar ridge preservation, immediate implants, horizontal and/or vertical ridge augmentation, and sinus floor augmentation). CONCLUSION: Within the past decade, great heterogeneity was observed among the outcomes considered in studies evaluating bone preservation/augmentation procedures. Three-dimensional radiographic bone gain/change was the most routinely reported main outcome variable, while PROMs were rarely reported.

Bone preservation or augmentation simultaneous with or prior to dental implant placement: A systematic review of outcomes and outcome measures used in clinical trials in the last 10 years.

AIM: To evaluate outcome measures and methods of assessment in clinical studies on bone augmentation/preservation procedures for the placement of dental implants. MATERIALS AND METHODS: A systematic search was performed on three databases from January 2011 to April 2021 to identify clinical studies reporting on any type of bone augmentation/preservation procedure. The outcomes that have been used to assess efficacy or performance in each study were registered and assigned to different domains (group of outcomes). The review followed the Preferred Reporting Items for Systematic Review and Meta-Analyses statement. RESULTS: Seven-hundred and eighty-three publications were included. Only 81.8% of the papers had a clear definition of their primary outcome. The rate of complications (59.3%), implant survival (58.2%), 3D radiographic bone gain/change (30%), marginal bone level (MBL; 29%), and histological outcomes (25.5%) were the most frequently reported outcome domains. The most commonly used primary outcome was 3D radiographic bone gain/change (25.8%), followed by implant survival (13.0%). Patient-reported outcome measures (PROMs) were reported in 15.7% of studies. Differences in the reported outcomes were observed among different types of bone preservation/augmentation interventions (i.e., alveolar ridge preservation, immediate implants, horizontal and/or vertical ridge augmentation, and sinus floor augmentation). CONCLUSION: Within the past decade, great heterogeneity was observed among the outcomes considered in studies evaluating bone preservation/augmentation procedures. Three-dimensional radiographic bone gain/change was the most routinely reported main outcome variable, while PROMs were rarely reported.

Evidence and risk indicators of non-random sampling in clinical trials in implant dentistry: A systematic appraisal.

AIM: Analysis of distribution of p-values of continuous differences between test and controls after randomization provides evidence of unintentional error, non-random sampling, or data fabrication in randomized controlled trials (RCTs). We assessed evidence of highly unusual distributions of baseline characteristics of subjects enrolled in clinical trials in implant dentistry. MATERIALS AND METHODS: RCTs published between 2005 and 2020 were systematically searched in Pubmed, Embase, and Cochrane databases. Baseline patient data were extracted from full text articles by two independent assessors. The hypothesis of non-random sampling was tested by comparing the expected and the observed distribution of the p-values of differences between test and controls after randomization. RESULTS: One-thousand five-hundred and thirty-eight unique RCTs were identified, of which 409 (26.6%) did not report baseline characteristics of the population, and 671 (43.6%) reported data in forms other than mean and standard deviation and could not be used to assess their random sampling. Four-hundred and fifty-eight trials with 1449 baseline variables in the form of mean and standard deviation were assessed. The study observed an over-representation of very small p-values [<.001, 1.38%, 95% confidence interval (CI) 0.85-2.12 compared to the expected 0.10%, 95% CI 0.00-0.26]. No evidence of over-representation of larger p-values was observed. Unusual distributions were present in 2.38% of RCTs and more frequent in non-registered trials, in studies supported by non-industry funding, and in multi-centre RCTs. CONCLUSIONS: The inability to assess random sampling due to insufficient reporting in 26.6% of trials requires attention. In trials reporting suitable baseline data, unusual distributions were uncommon, and no evidence of data fabrication was detected, but there was evidence of non-random sampling. Continued efforts are necessary to ensure high integrity and trust in the evidence base of the field.

Does machine-vision-assisted dynamic navigation improve the accuracy of digitally planned prosthetically guided immediate implant placement? A randomized controlled trial.

OBJECTIVES: This randomized controlled clinical trial was designed to compare the accuracy of machine-vision (MV)-based dynamic navigation (DN)-assisted immediate implant placement with the conventional freehand technique. MATERIAL AND METHODS: A total of 24 subjects requiring immediate implant placement in maxillary anterior teeth were randomly assigned to either the control (freehand by an experienced surgeon, n = 12) or the test group (MV-DN, n = 12). Implant platform, implant apex, angular, and depth deviations with respect to prosthetically guided digital planning and differences in implant insertion torque (ITV) and implant stability quotient (ISQ) were compared between the groups. RESULTS: MV-DN resulted in more accurate immediate implant position: significantly smaller global platform deviation (1.01 ± 0.41 mm vs. 1.51 ± 0.67 mm, p = .038), platform depth deviation (0.44 ± 0.46 mm vs. 0.95 ± 0.68 mm, p = .045), global apex deviation (0.88 ± 0.43 mm vs. 1.94 ± 0.86 mm, p = .001), and lateral apex deviation (0.68 ± 0.30 mm vs. 1.61 ± 0.88 mm, p = .004) were found in MV-DN compared to controls. No significant intergroup differences were observed for ITV and ISQ. CONCLUSIONS: MV-DN achieved more precise immediate implant position and comparable primary stability. Further trials are necessary to assess the benefits in terms of esthetics and tissue health/stability.

Accuracy and primary stability of tapered or straight implants placed into fresh extraction socket using dynamic navigation: a randomized controlled clinical trial.

OBJECTIVES: To compare the accuracy and primary stability of tapered and straight implants undergoing immediate implant placement with dynamic navigation. MATERIALS AND METHODS: Patients with compromised anterior teeth in maxilla were recruited and allocated randomly into (1) tapered implant group (TI group) and (2) straight implant group (SI group). Implants were inserted into fresh sockets with dynamic navigation. Three-dimensional platform deviation, apex deviation, angular deviation, insertion torque value (ITV) and implant stability quotient (ISQ) were recorded. RESULTS: Twenty patients with 20 implants were included. The overall platform, apex, and angular deviation were 0.87 ± 0.35 mm, 0.81 ± 0.34 mm, and 2.40 ± 1.31°, respectively. The accuracy was 0.86 ± 0.26 mm, 0.76 ± 0.33 mm, and 2.49 ± 1.54° for TI, and 0.89 ± 0.44 mm, 0.88 ± 0.36 mm, and 2.31 ± 1.01° for SI, with no significant difference (p = 0.85, 0.45, 0.76). Sagittal root position classification (SRP) class I may obtain greater error in numerical values in straight implants (0.97 ± 0.47 mm vs. 0.6 ± 0.16 mm, 0.92 ± 0.36 mm vs. 0.73 ± 0.36 mm, 2.48 ± 1.19° vs. 1.71 ± 0.14°). The overall ISQ was 60.74. ISQ was 60.48 for TI and 60.96 for SI, with no significant difference. Acceptable ITV (> 15 Ncm) was achieved in most of the included patients (SI 7/10, TI 9/10). CONCLUSIONS: High accuracy and primary stability of immediate implant placement could be achieved both in tapered and straight implants with dynamic navigation systems. CLINICAL RELEVANCE: Tapered and straight implants did not reach a consensus on which was better in immediate implant regarding to accuracy and primary stability. Our study demonstrated implant macrodesign did not affect accuracy and primary stability in immediate implant using dynamic navigation.

Accuracy of dynamic navigation in implant surgery: A systematic review and meta-analysis.

OBJECTIVE: To assess the accuracy of dynamic computer-assisted implant surgery. MATERIALS AND METHODS: An electronic search up to March 2020 was conducted using PubMed, Embase, and the Cochrane Central Register of Controlled Trial to identify studies using dynamic navigation in implant surgery, and additional manual search was performed as well. Clinical trials and model studies were selected. The primary outcome was accuracy. A single-arm meta-analysis of continuous data was conducted. Meta-regression was utilized for comparison on study design, guidance method, jaw, and systems. RESULTS: Ten studies, four randomized controlled trials (RCT) and six prospective studies, met the inclusion criteria. A total of 1,298 drillings and implants were evaluated. The meta-analysis of the accuracy (five clinical trials and five model studies) revealed average global platform deviation, global apex deviation, and angular deviation were 1.02 mm, 95% CI (0.83, 1.21), 1.33 mm, 95% CI (0.98, 1.67), and 3.59°, 95% CI (2.09, 5.09). Meta-regression shown no difference between model studies and clinical trials (p = .295, 0.336, 0.185), drilling holes and implant (p = .36, 0.279, 0.695), maxilla and mandible (p = .875, 0.632, 0.281), and five different systems (p = .762, 0.342, 0.336). CONCLUSION: Accuracy of dynamic computer-aided implant surgery reaches a clinically acceptable range and has potential in clinical usage, but more patient-centered outcomes and socio-economic benefits should be reported.

Bovine-Derived Xenografts Immobilized With Cryopreserved Stem Cells From Human Adipose and Dental Pulp Tissues Promote Bone Regeneration: A Radiographic and Histological Study.

Adipose tissue-derived stem cells (ADSCs) and dental pulp stem cells (DPSCs) have become promising sources for bone tissue engineering. Our study aimed at evaluating bone regeneration potential of cryopreserved ADSCs and DPSCs combined with bovine-derived xenografts with 10% porcine collagen. In vitro studies revealed that although DPSCs had higher proliferative abilities, ADSCs exhibited greater mineral depositions and higher osteogenic-related gene expression, indicating better osteogenic differentiation potential of ADSCs. After applying cryopreserved ADSCs and DPSCs in a critical-sized calvarial defect model, both cryopreserved mesenchymal stem cells significantly improved bone volume density and new bone area at 2, 4, and 8 weeks. Furthermore, the combined treatment with ADSCs and xenografts was more efficient in enhancing bone repair processes compared to combined treatment with DPCSs at all-time points. We also evaluated the sequential early bone healing process both histologically and radiographically, confirming a high agreement between these two methods. Based on these results, we propose grafting of the tissue-engineered construct seeded with cryopreserved ADSCs as a useful strategy in accelerating bone healing processes.