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Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Study in the Therapy of Periimplantitis: Scaling Versus Low Abrasive Powder
Study Start Date : January 2011
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : January 2012
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Pocket probing depth [ Time Frame: Twelve months ]

Secondary Outcome Measures :
  1. Assessment of pain levels [ Time Frame: One week and six months ]
  2. Assessment of the oral health related quality of life using the OHIP (14) [ Time Frame: One , three, six and twelve months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
More Information

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
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: October 2010

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