Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

University of Heidelberg

ClinicalTrials.gov Identifier:

NCT01256996

First received: December 2, 2010

Last updated: December 8, 2010

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 2, 2010
Last Updated Date	December 8, 2010
Start Date ^ICMJE	January 2011
Estimated Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 8, 2010)	Pocket probing depth [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01256996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 8, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder
Official Title ^ICMJE	A Randomized Multicenter Study in the Therapy of Periimplantitis: Scaling Versus Low Abrasive Powder
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Peri-implantitis
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Low-abrasive powder Intervention: Procedure: Air abrasion of the implant surface with a low abrasive powder
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	January 2012
Estimated Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01256996
Other Study ID Numbers ^ICMJE	MV-329/2009
Has Data Monitoring Committee	Not Provided
Responsible Party	Clovis Mariano Faggion Jr. and Marc Schmitter, University of Heidelberg
Study Sponsor ^ICMJE	University of Heidelberg
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Heidelberg
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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