Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

December 8, 2010 updated by: Heidelberg University

A Randomized Multicenter Study in the Therapy of Periimplantitis: Scaling Versus Low Abrasive Powder

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-abrasive powder
Procedure: Air abrasion of the implant surface with a low abrasive powder
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pocket probing depth
Time Frame: Twelve months
Twelve months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of pain levels
Time Frame: One week and six months
One week and six months
Assessment of the oral health related quality of life using the OHIP (14)
Time Frame: One , three, six and twelve months
One , three, six and twelve months

Collaborators and Investigators

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

Sponsor

Heidelberg University

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

January 1, 2011

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Estimate)

December 9, 2010

Last Update Submitted That Met QC Criteria

December 8, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV-329/2009

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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