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

Jaw, Edentulous, Partially Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350075
• Other study ID #: 2012CB933600
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: March 1, 2017

Study information

• Verified date: May 2019
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

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.

Locations

Country	Name	City	State
China	Jun-Yu Shi	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

References & Publications (5)

Lai HC, Si MS, Zhuang LF, Shen H, Liu YL, Wismeijer D. Long-term outcomes of short dental implants supporting single crowns in posterior region: a clinical retrospective study of 5-10 years. Clin Oral Implants Res. 2013 Feb;24(2):230-7. doi: 10.1111/j.1600-0501.2012.02452.x. Epub 2012 Apr 2. — View Citation

Mangano FG, Shibli JA, Sammons RL, Iaculli F, Piattelli A, Mangano C. Short (8-mm) locking-taper implants supporting single crowns in posterior region: a prospective clinical study with 1-to 10-years of follow-up. Clin Oral Implants Res. 2014 Aug;25(8):933-40. doi: 10.1111/clr.12181. Epub 2013 Apr 28. — View Citation

Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x. Review. — View Citation

Tan WC, Lang NP, Zwahlen M, Pjetursson BE. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. Part II: transalveolar technique. J Clin Periodontol. 2008 Sep;35(8 Suppl):241-54. doi: 10.1111/j.1600-051X.2008.01273.x. Review. — View Citation

Thoma DS, Haas R, Tutak M, Garcia A, Schincaglia GP, Hämmerle CH. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 1: demographics and patient-reported outcomes at 1 year of loading. J Clin Periodontol. 2015 Jan;42(1):72-80. doi: 10.1111/jcpe.12323. Epub 2014 Dec 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Marginal bone loss	Alveolar bone loss around dental implants during the observation period	1 year after implant placement
Secondary	Complication rate	Both biological and mechanical complications will be recorded	1 year after implant placement
Secondary	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