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Clinical evaluation of short 6-mm implants alone, short 8-mm implants combined with osteotome sinus floor elevation and standard 10-mm implants combined with osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial.

ABSTRACT: Nowadays, short dental implants are being increasingly applied in extremely resorbed posterior regions. The recent studies have indicated that short implants present a similar success rate to conventional implants. It is assumed that short implants can avoid additional surgical morbidity and are less technically demanding. However, high-quality evidence (? Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of short implants and longer implants combined with osteotome sinus floor elevation (OSFE) technique is limited.The proposed study is designed as a prospective single-center, three-arm parallel group, randomized controlled trial. We plan to enroll 150 patients in need of dental implant treatment in the posterior maxilla. The inclusion criteria include: age ? 18 years, partial edentulism in the posterior maxilla for at least 3 months from tooth loss, residual bone height ranging from 6 to 8 mm, sufficient bone width (? 6 mm) in the edentulous region. The patients will be divided into three groups according to a table of random numbers: group 1: short implants (6 mm) alone; group 2: short implants (8 mm) combined with osteotome sinus floor elevation (OSFE); group 3: standard implants (10 mm) combined with OSFE. The assignment will be concealed from the clinical operators until the beginning of implant surgery. The outcome examiners and patients will be kept blinded to the assignment. Implant survival rates, implant success rates, complications, resonance frequency analysis (RFA) measurements, marginal bone level, treatment time and patient-reported outcome (visual analogue scale for intraoperative discomfort and postoperative pain) will be recorded. Clinical re-evaluations will be performed at 12, 24, 36 and 60 months after crown placement.The results of the trial will support better decision-making for dental implant treatment in atrophic maxillary ridges. If favorable, the use of short implants may avoid adjunct procedures used for implant insertion, thus reducing operative time, complexity and postoperative discomfort.Clinicaltrials.gov identifier: NCT02350075 (registered on 17 February 2015).

SUBMITTER: Shi JY

PROVIDER: S-EPMC4518682 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Clinical evaluation of short 6-mm implants alone, short 8-mm implants combined with osteotome sinus floor elevation and standard 10-mm implants combined with osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial.

Shi Jun-Yu JY Gu Ying-Xin YX Qiao Shi-Chong SC Zhuang Long-Fei LF Zhang Xiao-Meng XM Lai Hong-Chang HC

Trials 20150730

<h4>Background</h4>Nowadays, short dental implants are being increasingly applied in extremely resorbed posterior regions. The recent studies have indicated that short implants present a similar success rate to conventional implants. It is assumed that short implants can avoid additional surgical morbidity and are less technically demanding. However, high-quality evidence (≥ Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of short implants and longer ...[more]

PMID: 26223254

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Project description:BACKGROUND:Implant placement in the posterior maxilla is often complicated by the insufficient bone volume. While transalveolar sinus floor elevation (TSFE) has been proven as a predictable surgical procedure to increase the bone height in the posterior maxilla, questions in regard to the necessity of the bone grafting during the sinus lift and the question of whether TSFE could be performed when the residual bone height is below 5 mm are still debated. Furthermore, high-quality evidence comparing the clinical outcome of transalveolar sinus floor elevation with osteotome and modified sinus floor elevation with crestal non-cutting drills is limited. METHODS/DESIGN:One hundred twenty adult patients who fit the inclusion criteria are being recruited from the Peking University Hospital of Stomatology First Clinical Division (Beijing, China). All patients are assigned to one of four groups according to a table of random numbers. Participants will receive (1) TSFE using osteotomes with bone grafting, (2) TSFE using osteotomes without bone grafting, (3) modified TSFE with bone grafting, or (4) modified TSFE without bone grafting. In a one-year follow-up period, implant survival rates, complications, implant stability, bone remodeling around the implant, and patient-reported outcome (visual analog scale for intraoperative discomfort and postoperative pain) will be observed and documented. The implant stability will be gauged by the resonance frequency analysis six times (at baseline and weeks 6, 8, 12, 16, and 26), and the bone remodeling will be observed and compared via radiographic examinations. DISCUSSION:The result of the trial will potentially contribute to better decision making in atrophic posterior maxilla when implant placement is needed. Therefore, if the outcome is deemed favorable, the use of the modified TSFE would achieve an outcome equivalent to that of the traditional TSFE while introducing less trauma and postoperative discomforts. Separately, whether the bone graft procedure is necessary for the TSFE will also be discussed. TRIAL REGISTRATION:The study has been registered in ClinicalTrials.gov under the identifier number NCT03445039 . Registered on 26 February 2018.

Project description:ObjectivesTo compare the use of short implants (?6?mm) in atrophic posterior maxilla versus longer implants (?10?mm) with sinus floor elevation.DesignA systematic review and meta-analysis based on randomised controlled trials (RCTs).Data sourcesElectronic searches were conducted in PubMed, Embase and the Cochrane CENTRAL. Retrospective and prospective hand searches were also performed.Eligibility criteriaRCTs comparing short implants (?6?mm) and longer implants (?10?mm) with sinus floor elevation were included. Outcome measures included implant survival (primary outcome), marginal bone loss (MBL), complications and patient satisfaction.Data extraction and synthesisRisks of bias in and across studies were evaluated. Meta-analysis, subgroup analysis and sensitivity analysis were undertaken. Quality of evidence was assessed according to Grading of Recommendations Assessment, Development and Evaluation.ResultsA total of seven RCTs involving 310 participants were included. No significant difference in survival rate was found for 1-3?years follow-up (RR 1.01, 95%?CI 0.97 to 1.04, p=0.74, I²=0%, moderate-quality evidence) or for 3?years or longer follow-up (RR 1.00, 95%?CI 0.97 to 1.04, p=0.79, I²=0%, moderate-quality evidence). However, short implants (?6?mm) showed significantly less MBL in 1-3?years follow-up (MD=-0.13?mm, 95%?CI -0.21 to 0.05; p=0.001, I²=87%, low-quality evidence) and in 3?years or longer follow-up (MD=-0.25?mm, 95%?CI -0.40 to 0.10; p=0.001, I²=0%, moderate-quality evidence). In addition, short implant (?6?mm) resulted in fewer postsurgery reaction (RR 0.11, 95%?CI 0.14 to 0.31, p<0.001, I²=40%, moderate-quality evidence) and sinus perforation or infection (RR 0.11, 95%?CI 0.02 to 0.63, p=0.01, I²=0%, moderate-quality evidence).ConclusionsFor atrophic posterior maxilla, short implants (?6?mm) are a promising alternative to sinus floor elevation, with comparable survival rate, less MBL and postsurgery reactions. Additional high-quality studies are needed to evaluate the long-term effectiveness of short implants (?6?mm).Trial registeration numberThe protocol has been registered at PROSPERO (CRD42018103531).

Project description:BackgroundCurrently, insufficient bone volume always occurs in the posterior maxilla which makes implantation difficult. Short implants combined with transcrestal sinus floor elevation (TSFE) may be an option to address insufficient bone volume.PurposeThe clinical performance of short implants combined with TSFE was compared with that of conventional implants combined with TSFE according to the survival rate.MethodIn this systematic review and meta-analysis, we followed the Meta-Analysis of Observational Studies in Epidemiology (MOOSE) guidelines. Articles were identified through PubMed, Embase, the Cochrane Library, and manual searching. Eligibility criteria included clinical human studies. The quality assessment was performed according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. The odds ratio (OR) with its confidence interval (CI) was considered the essential outcome for estimating the effect of short implants combined with TSFE.ResultsThe registration number is INPLASY202050092. Eleven studies met the inclusion criteria, including 1 cohort study and 10 cross-sectional studies. With respect to the 1-year survival rate, no significant effect was observed between short implants (length ≤ 8 mm) and conventional implants combined with TSFE (I2=0%, OR=1.04, 95% CI: 0.55-1.96). Similarly, no difference was seen between the two groups regarding the survival rate during the healing period (I2=10%, OR=0.74, 95% CI: 0.28-1.97) and 3-year loading (OR=1.76, 95% CI: 0.65-4.74).ConclusionThere was no evidence that the survival rate of short implants combined with TSFE was lower or higher than that of conventional implants combined with TSFE when the residual bone height was poor and the implant protrusion length of short implants was less than or similar to conventional implants. Nevertheless, the results should be interpreted cautiously due to the lack of random controlled trials in our meta-analysis.

Project description:In edentulous patients, bone resorption cannot allow the installation of standard implants and it is demanded to use short implants in the residual alveolar bone or longer implants in grafted bone. To compare the survival and bone level changes of standard plus short 4-mm implants used as distal support of a maxillary full-arch fixed dental prostheses (FDPs) with standard (10-mm) implants placed in association with a bilateral sinus floor augmentation procedure. Full-arch FDPs supported by six implants were randomly placed in both groups. In the control group, all implants were 10 mm long and 4.1 mm in diameter. The distal implant in both sides of the maxilla was installed after 4 months from bilaterally sinus floor elevation. In the test group (short group), the distal implant in both sides of the maxilla was 4 mm long and 4.1 mm in diameter. No sinus floor elevations were performed in the test group. Clinical assessments and X-rays were taken at prosthesis delivering and after 6, 12, 18, and 24 months. Patient-reported outcome measures (PROMs) were also evaluated before surgery and after 6, 12, and 24 months. The changes over time of the bone level for the short implants were -0.01 ± 0.11 mm, -0.04 ± 0.13 mm, -0.17 ± 0.29 mm, and -0.28 ± 0.37 mm after 6, 12, 18, and 24 months from prosthesis delivering, respectively. For the standard implants, bone changes were -0.21 ± 0.33 mm (p = 0.103), -0.30 ± 0.32 mm (p = 0.023), -0.40 ± 0.37 mm (p = 0.144), and -0.54 ± 0.49 mm (p = 0.128), respectively. A statistically relevant difference was found only at 12 months after loading between the two groups. Similar results on implant survival rate and marginal bone loss were observed for the short and standard implants, placed in association with a bilateral sinus floor augmentation procedure, used as distal support of a maxillary full-arch FDP. A statistically relevant difference was found only at 12 months after loading between the two groups (p = 0.023).

Project description:BackgroundOsteotome sinus floor elevation (OSFE) is used to increase the bone volume at the site of the maxillary sinus through the transalveolar approach. However, there is uncertainty regarding the necessity of the use of grafting material in order to maintain the space for new bone formation.ObjectiveThis study aimed to evaluate new bone formation 6 months after osteotome sinus floor elevation without grafting and to evaluate the correlations between residual bone height (RBH), implant protrusion length (IPL), and endo-sinus bone gain (ESBG).Material and methodsThirty-one implants (27 patients) from area 14-17 and 24-27 were included in the study. All implants had a history of OSFE without grafting, with cone beam computed tomography (CBCT) taken prior to the surgery. The clinical examination and radiographic examination using CBCT were performed again 6 months after implantation. The RBH, new bone level, ESBG, and IPL were measured. Paired sample t test and Pearson correlation were used to analyze the data.ResultsThe average RBH before surgery was 7.14 ± 1.07 mm and 6 months after surgery was 8.95 ± 1.17 mm. There was a significant increase in new bone formation in the 6 months following surgery (p < 0.05). The average ESBG and IPL were 1.8 ± 0.79 mm and 2.02 ± 0.73 mm, respectively. There was a significant positive correlation between the IPL and ESBG (p < 0.05) while there was a negative correlation between RBH and ESBG. This study also demonstrates a decrease in the percentage of bone formation in relation to IPL as the IPL increases. The survival rate of the implant was 100%.ConclusionSignificant new bone formation can be detected around the implant site 6 months after implantation using OSFE technique without grafting. There is a negative correlation between the RBH and ESBG. While IPL is correlated to ESBG and appears to be the influencing factors of bone formation changes in the maxillary sinus. The preliminary radiographic results suggest that OSFE technique without grafting in combination with optimal IPL can provide sufficient bone height for implant support with a 100% implant survival rate.

Dataset Information

Clinical evaluation of short 6-mm implants alone, short 8-mm implants combined with osteotome sinus floor elevation and standard 10-mm implants combined with osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial.

Publications

Clinical evaluation of short 6-mm implants alone, short 8-mm implants combined with osteotome sinus floor elevation and standard 10-mm implants combined with osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial.

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