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
  Purpose

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.


Condition Intervention Phase
Peri-implantitis
Procedure: Air abrasion of the implant surface with a low abrasive powder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Study in the Therapy of Periimplantitis: Scaling Versus Low Abrasive Powder

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Pocket probing depth [ Time Frame: Twelve months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Clovis Mariano Faggion Jr. and Marc Schmitter, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01256996     History of Changes
Other Study ID Numbers: MV-329/2009
Study First Received: December 2, 2010
Last Updated: December 8, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Peri-Implantitis
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases

ClinicalTrials.gov processed this record on July 20, 2014