Clinical Trial: Surface Decontamination in Treatment of Peri-Implantitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effects of Implant Surface Decontamination on Control of Peri-Implant Inflammation

Brief Summary:

Peri-implantitis represents a major biological complication of implant dentistry with reported prevalence of up to 47% of implants. The disease is characterized by inflammatory response to the biofilm inhabiting the implant surface. To treat this inflammatory disease, surgical and non-surgical therapies have been proposed, all of which entail biofilm removal through implant surface decontamination. Systematic review of various surface decontamination protocols has failed to demonstrate superiority of any of the protocols. One possible explanation is that most studies have examined decontamination of implant surfaces following experimentally-induced peri-implantitis, where implant surfaces lack the tenacious mineralized biofilm often found in clinical peri-implantitis and are therefore easily decontaminated.

The investigators have hypothesized that control of inflammation and repair of pathologically damaged peri-implant tissues requires a comprehensive mechanical plus chemical surface decontamination therapy. The aims of this study are to 1) determine the most effective surface decontamination protocol that can lead to control of peri-implant inflammation and 2) delineate the microbial and immunological mediators that are associated with the changes in peri-implant inflammation. The investigators propose to compare conventional implant surface contamination techniques to a comprehensive mechanical plus chemical protocol. This randomized controlled clinical trial seeks to enroll 68 participants with at least one implant diagnosed with moderate to severe peri-implantitis. Pre-op parameters to be assessed include: probing pocket depth, bleeding on probing, suppuration, plaque index, marginal inflammation, recession, clinical attachment level, inflammatory biomarkers and microbial sampling, and digital intra-oral peri-apical radiograph. Subjects will be randomly assigned to o

Detailed Summary:
Sponsor: University of Southern California

Current Primary Outcome:

  • Bleeding on Probing (BOP) [ Time Frame: 3 months ]
    A periodontal probe will be used at 6 locations around each implant (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual). Presence of gingival bleeding upon probing will be recorded. This will be a binary outcome (Yes or No)
  • Suppuration upon probing [ Time Frame: 3 months ]
    A periodontal probe will be used at 6 locations around each implant (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual). Presence of suppuration upon probing will be recorded. This will be a binary outcome (Yes or No)
  • Probing Pocket Depth (PPD) [ Time Frame: 3 months ]
    Distance from the gingival margin to the depth of the pocket


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Marginal bone loss [ Time Frame: 3 month ]
    Measurement from the implant platform to first bone-to-implant contact
  • Inflammatory biomarkers [ Time Frame: 3 months ]
    Inflammatory biomarkers in the peri-implant crevicular fluid (PICF)
  • Microbial profile [ Time Frame: 3 months ]
    Microbial profile in the peri-implant crevicular fluid (PICF)


Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: April 3, 2017
Date Started: September 1, 2017
Date Completion: September 1, 2020
Last Updated: April 18, 2017
Last Verified: April 2017