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Clinical Trials/NCT03114956
NCT03114956
Withdrawn
Not Applicable

Effects of Implant Surface Decontamination on Control of Peri-Implant Inflammation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-implantitis
Sponsor
University of Southern California
Primary Endpoint
Bleeding on Probing (BOP)
Status
Withdrawn
Last Updated
6 years ago

Overview

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 one of the four surgical debridement intervention groups: (A) gauzes soaked in sterile saline and chlorhexidine; (B) Titanium brush; (C) Air power abrasion; (D) comprehensive surface decontamination, including titanium brush, air powder abrasion and surface etching with 9.6% hydrofluoric acid gel. At 3-months post-operative, the initial clinical assessment will be repeated. The clinical examination will be used to analyze the efficacy of each treatment in controlling peri-implant mucosal inflammation. The ultimate objective of this research is not only to identify an effective method for control of peri-implant inflammation, but also to lay the foundation to detect biomarkers of peri-implantitis that can potentially be helpful in future studies as risk factors of this disease.

Registry
clinicaltrials.gov
Start Date
June 19, 2019
End Date
June 19, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Neema Bakhshalian

Assistant Professor

University of Southern California

Eligibility Criteria

Inclusion Criteria

  • PPD \>6 mm
  • Positive BOP
  • Peri-implant marginal bone loss (MBL) \>3 mm
  • Age: 18 to 75 years
  • Exclusion Criteria
  • Implant mobility
  • Current cancer
  • Steroids use (last 2 years)
  • Bisphosphonates use (last 4 years)
  • Uncontrolled diabetes (HBA1c \>7)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Marginal bone loss(3 month)
  • Inflammatory biomarkers(3 months)
  • Microbial profile(3 months)

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