Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

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. Identifier: NCT01256996
Recruitment Status : Unknown
Verified October 2010 by Heidelberg University.
Recruitment status was:  Enrolling by invitation
First Posted : December 9, 2010
Last Update Posted : December 9, 2010
Information provided by:
Heidelberg University

December 2, 2010
December 9, 2010
December 9, 2010
January 2011
April 2011   (Final data collection date for primary outcome measure)
Pocket probing depth [ Time Frame: Twelve months ]
Same as current
No Changes Posted
  • Assessment of pain levels [ Time Frame: 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 ]
Same as current
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Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder
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.

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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Experimental: Low-abrasive powder
Intervention: Procedure: Air abrasion of the implant surface with a low abrasive powder
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2012
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Clovis Mariano Faggion Jr. and Marc Schmitter, University of Heidelberg
Heidelberg University
Not Provided
Not Provided
Heidelberg University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP