Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder
Primary Purpose
Peri-implantitis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Air abrasion of the implant surface with a low abrasive powder
Sponsored by
About this trial
This is an interventional treatment trial for Peri-implantitis
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate peri-implantitis
- age ≥18 years
- capacity to contract
- no subgingival debridement within the last six months
- informed consent
Exclusion Criteria:
- pregnancy
- subgingival debridement within the last six months
- bleeding tendency
- usage of antibiotics within the last three months
- insufficient restorations (including caries etc.)
- Diabetes mellitus
- smoker
- implantats with platform switch
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low-abrasive powder
Arm Description
Outcomes
Primary Outcome Measures
Pocket probing depth
Secondary Outcome Measures
Assessment of pain levels
Assessment of the oral health related quality of life using the OHIP (14)
Full Information
NCT ID
NCT01256996
First Posted
December 2, 2010
Last Updated
December 8, 2010
Sponsor
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT01256996
Brief Title
Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder
Official Title
A Randomized Multicenter Study in the Therapy of Periimplantitis: Scaling Versus Low Abrasive Powder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
4. Oversight
5. Study Description
Brief Summary
In the last decade, the number of dental implantations continuously increases. However, at the same time, the prevalence of peri-implantitis increases, too. Although both surgical and non-surgical interventions are available for the therapy, there is no efficient and satisfying therapy option resulting in an adequate improvement of this disease.
An innovative, low abrasive powder has been introduced for the therapy of periodontitis. However, the powder might be suitable for the peri-implantitis therapy, also, and could improve the effectiveness of the therapy. The usage of this powder in peri-implantitis patients has not been assessed in a clinical trial although the effectiveness in natural teeth has been demonstrated.
The aim of this prospective, randomised, multi-centre trial is to assess the effectiveness of the aforementioned powder in peri-implantitis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implantitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-abrasive powder
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Air abrasion of the implant surface with a low abrasive powder
Intervention Description
Test treatment will be performed using the low abrasive powder in a standard air-polishing unit, which will be set up according to the manufacturer's instructions. The unit will be set to a medium water and powder setting, and the powder chamber will be filled to the indicated maximum powder level before treatment to ensure reproducible treatment conditions. The jet will be directed to the periodontal pocket for 5 s per surface (vestibular, lingual, mesio and distal) for subgingival plaque removal.
Primary Outcome Measure Information:
Title
Pocket probing depth
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
Assessment of pain levels
Time Frame
One week and six months
Title
Assessment of the oral health related quality of life using the OHIP (14)
Time Frame
One , three, six and twelve months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate peri-implantitis
age ≥18 years
capacity to contract
no subgingival debridement within the last six months
informed consent
Exclusion Criteria:
pregnancy
subgingival debridement within the last six months
bleeding tendency
usage of antibiotics within the last three months
insufficient restorations (including caries etc.)
Diabetes mellitus
smoker
implantats with platform switch
12. IPD Sharing Statement
Learn more about this trial
Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder
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