Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

NCT01256996 | Unknown Phase 2

• 1 other identifier: MV-329/2009
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peri-implantitis

Outcome Measures

Primary Outcomes (1)

• Pocket probing depth

  Twelve months

Secondary Outcomes (2)

• Assessment of pain levels

  One week and six months

• Assessment of the oral health related quality of life using the OHIP (14)

  One , three, six and twelve months

Study Arms (1)

Low-abrasive powder

EXPERIMENTAL

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

Interventions

Air abrasion of the implant surface with a low abrasive powder PROCEDURE

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.

Low-abrasive powder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate peri-implantitis
• age ≥18 years
• capacity to contract
• no subgingival debridement within the last six months
• informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 9, 2010
• Study Start: January 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 9, 2010

Record last verified: 2010-10