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Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

Primary Purpose

Peri-implantitis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Air abrasion of the implant surface with a low abrasive powder
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implantitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Low-abrasive powder

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pocket probing depth

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 2, 2010
    Last Updated
    December 8, 2010
    Sponsor
    Heidelberg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01256996
    Brief Title
    Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder
    Official Title
    A Randomized Multicenter Study in the Therapy of Periimplantitis: Scaling Versus Low Abrasive Powder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    April 2011 (Anticipated)
    Study Completion Date
    January 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Heidelberg University

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peri-implantitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low-abrasive powder
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Air abrasion of the implant surface with a low abrasive powder
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pocket probing depth
    Time Frame
    Twelve months
    Secondary Outcome Measure Information:
    Title
    Assessment of pain levels
    Time Frame
    One week and six months
    Title
    Assessment of the oral health related quality of life using the OHIP (14)
    Time Frame
    One , three, six and twelve months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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    Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

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