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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02350075
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Procedure: Dental implants installation Device: Osteotome Sinus floor elevation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 1, 2015
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Marginal bone loss [ Time Frame: 1 year after implant placement ]
    Alveolar bone loss around dental implants during the observation period

  2. Complication rate [ Time Frame: 1 year after implant placement ]
    Both biological and mechanical complications will be recorded

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350075


Locations
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China, Shanghai
Jun-Yu Shi
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Junyu Shi, Medical Doctor, Department of oral and maxillofacial implants, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02350075    
Other Study ID Numbers: 2012CB933600
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Keywords provided by Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
short implants
sinus floor elevation
randomized controlled trial
Additional relevant MeSH terms:
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Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases