Clinical Success of Short Dental Implants Alone and Standard Dental Implants Combined With Osteotome Sinus Floor Elevation in Posterior Maxillae

Study Overview
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Brief Summary
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The aim of this study is to determine the clinical success of short implants (6mm) alone and standard implants (10mm) combined with sinus floor elevation in atrophic maxilla.

Detailed Description
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Implant treatment in posterior maxilla is commonly faced with great challenges due to the limited residual bone height and poor bone quality. Efforts have been made to allow successful implant treatment in atrophic posterior maxillae.Osteotome sinus floor elevation (OSFE) has been proven to be a predictable surgical procedure to vertically increase the bone volume in atrophic maxilla.On the other hand, short implants (intra-bony length of 8mm or less) are being increasingly used in extremely resorbed maxilla to avoid additional surgical trauma and expense.However, still limited randomized controlled trials have compared the clinical success of short implants and standard implants combined with OSFE. This study is designed as a prospective randomized controlled clinical study. We plan to enroll 180 patients in need of dental implant treatment in posterior maxilla. All patients will sign the informed consent form before treatment. The study is approval by the Ethics Committee of Shanghai Ninth People Hospital, China. The clinical component of the study will be initiated in May 2015 at the Department of Oral and Maxillofacial Implantology, Shanghai Ninth People Hospital, Shanghai Jiao-Tong University, China. A block randomization sequence will be used to assign eligible patients to three groups: Group 1: short implants (6mm) alone; Group 2: standard implants (10mm) 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. The required sample size is calculated based on the primary outcome parameter, implant survival rate. A recent study (Rossi et al. 2016) compared survival rate of short implants and standard implants (Survival rate: 86.7% VS 96.7%). If α=0.05, and 1-β =0.8, a sample size of n=116 per group is required. Assuming a drop-out rate of 10%, 125 patients per group will be required. The total required sample size will thus be n=250.

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Procedure: Dental implants installation
* Device: Osteotome Sinus floor elevation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The following inclusion criteria are applied: age≧18 years, partial edentulism in posterior maxilla for at least three months from tooth loss, residual bone height range from 6-8mm, sufficient bone width in edentulous region. Exclusion Criteria: The patients will be excluded on the basis of: heavy smoker (>10 cigarettes per days), uncontrolled diabetes mellitus or other systemic diseases, uncontrolled periodontal infection, insufficient bone quality to achieve implant stability and previous implant installation or bone grafting at surgical site.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short implants group<br>Patients receive short dental implants installation (6mm) without additional augmentation procedures. | Procedure: Dental implants installation<br>* Dental implants installation is a procedure to insert dental implants into alveolar bone.<br>|
| Other: Standard implants with OSFE group<br>Patients receive standard dental implants installation (10mm) combined with osteotome sinus floor elevation. | Procedure: Dental implants installation<br>* Dental implants installation is a procedure to insert dental implants into alveolar bone.<br>Device: Osteotome Sinus floor elevation<br>* Osteotomes with different diameters are specially-designed device to vertically increase the bone volume in atrophic maxilla.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implants survival rate | Survival rate is defined by percentage of dental implants that remained in situ with or without modifications. | 1 year after implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss | Alveolar bone loss around dental implants during the observation period | 1 year after implant placement | 
| Complication rate | Both biological and mechanical complications will be recorded | 1 year after implant placement | 
| Patient-reported outcome (100-mm visual analogue scale (VAS) | Patients will be asked to give their answer regarding surgical comfort using a 100-mm visual analogue scale (VAS) with word very dissatisfied to very satisfied on the left and right end respectively | 10 minutes after implant surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short implants, sinus floor elevation, randomized controlled trial