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

May 14, 2019 updated by: Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Jun-Yu Shi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implants survival rate
Time Frame: 1 year after implant placement
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
Time Frame: 1 year after implant placement
Alveolar bone loss around dental implants during the observation period
1 year after implant placement
Complication rate
Time Frame: 1 year after implant placement
Both biological and mechanical complications will be recorded
1 year after implant placement
Patient-reported outcome (100-mm visual analogue scale (VAS)
Time Frame: 10 minutes after implant surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 24, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012CB933600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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