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

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dental implants installation
Osteotome Sinus floor elevation
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring short implants, sinus floor elevation, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jun-Yu Shi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Short implants group

Standard implants with OSFE group

Arm Description

Patients receive short dental implants installation (6mm) without additional augmentation procedures.

Patients receive standard dental implants installation (10mm) combined with osteotome sinus floor elevation.

Outcomes

Primary Outcome Measures

Implants survival rate
Survival rate is defined by percentage of dental implants that remained in situ with or without modifications.

Secondary Outcome Measures

Marginal bone loss
Alveolar bone loss around dental implants during the observation period
Complication rate
Both biological and mechanical complications will be recorded
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

Full Information

First Posted
January 19, 2015
Last Updated
May 14, 2019
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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1. Study Identification

Unique Protocol Identification Number
NCT02350075
Brief Title
Clinical Success of Short Dental Implants Alone and Standard Dental Implants Combined With Osteotome Sinus Floor Elevation in Posterior Maxillae
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (undefined)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
short implants, sinus floor elevation, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short implants group
Arm Type
Experimental
Arm Description
Patients receive short dental implants installation (6mm) without additional augmentation procedures.
Arm Title
Standard implants with OSFE group
Arm Type
Other
Arm Description
Patients receive standard dental implants installation (10mm) combined with osteotome sinus floor elevation.
Intervention Type
Procedure
Intervention Name(s)
Dental implants installation
Intervention Description
Dental implants installation is a procedure to insert dental implants into alveolar bone.
Intervention Type
Device
Intervention Name(s)
Osteotome Sinus floor elevation
Intervention Description
Osteotomes with different diameters are specially-designed device to vertically increase the bone volume in atrophic maxilla.
Primary Outcome Measure Information:
Title
Implants survival rate
Description
Survival rate is defined by percentage of dental implants that remained in situ with or without modifications.
Time Frame
1 year after implant placement
Secondary Outcome Measure Information:
Title
Marginal bone loss
Description
Alveolar bone loss around dental implants during the observation period
Time Frame
1 year after implant placement
Title
Complication rate
Description
Both biological and mechanical complications will be recorded
Time Frame
1 year after implant placement
Title
Patient-reported outcome (100-mm visual analogue scale (VAS)
Description
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
Time Frame
10 minutes after implant surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Jun-Yu Shi
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23621393
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.
Results Reference
background
PubMed Identifier
22469075
Citation
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.
Results Reference
background
PubMed Identifier
18724853
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.
Results Reference
background
PubMed Identifier
18724852
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.
Results Reference
background
PubMed Identifier
25418606
Citation
Thoma DS, Haas R, Tutak M, Garcia A, Schincaglia GP, Hammerle 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.
Results Reference
background
PubMed Identifier
27389435
Citation
Zhang XM, Shi JY, Gu YX, Qiao SC, Mo JJ, Lai HC. Clinical Investigation and Patient Satisfaction of Short Implants Versus Longer Implants with Osteotome Sinus Floor Elevation in Atrophic Posterior Maxillae: A Pilot Randomized Trial. Clin Implant Dent Relat Res. 2017 Feb;19(1):161-166. doi: 10.1111/cid.12435. Epub 2016 Jul 8.
Results Reference
derived
PubMed Identifier
26223254
Citation
Shi JY, Gu YX, Qiao SC, Zhuang LF, Zhang XM, Lai HC. 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. Trials. 2015 Jul 30;16:324. doi: 10.1186/s13063-015-0853-4.
Results Reference
derived

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

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