Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01256996
First received: December 2, 2010
Last updated: December 8, 2010
Last verified: October 2010

December 2, 2010
December 8, 2010
January 2011
April 2011   (final data collection date for primary outcome measure)
Pocket probing depth [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01256996 on ClinicalTrials.gov Archive Site
  • Assessment of pain levels [ Time Frame: One week and six months ] [ Designated as safety issue: Yes ]
  • Assessment of the oral health related quality of life using the OHIP (14) [ Time Frame: One , three, six and twelve months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Peri-implantitis
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01256996
MV-329/2009
Not Provided
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