Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

Peri-implantitis Clinical Trial

Official title:

A Randomized Multicenter Study in the Therapy of Periimplantitis: Scaling Versus Low Abrasive Powder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01256996
• Other study ID #: MV-329/2009
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: December 2, 2010
• Last updated: December 8, 2010
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2010
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peri-implantitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket probing depth		Twelve months	No
Secondary	Assessment of pain levels		One week and six months	Yes
Secondary	Assessment of the oral health related quality of life using the OHIP (14)		One , three, six and twelve months	No