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Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

Sponsor
Heidelberg University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01256996
Collaborator
(none)
40
Enrollment
1
Arm
12
Duration (Months)

Study Details

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
  • Procedure: Air abrasion of the implant surface with a low abrasive powder
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2011
Anticipated Primary Completion Date :
Apr 1, 2011
Anticipated Study Completion Date :
Jan 1, 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 [Twelve months]

Secondary Outcome Measures

  1. Assessment of pain levels [One week and six months]

  2. Assessment of the oral health related quality of life using the OHIP (14) [One , three, six and twelve months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Heidelberg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01256996
Other Study ID Numbers:
  • MV-329/2009
First Posted:
Dec 9, 2010
Last Update Posted:
Dec 9, 2010
Last Verified:
Oct 1, 2010
Additional relevant MeSH terms:
Peri-Implantitis

Study Results

No Results Posted as of Dec 9, 2010