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Surface Decontamination in Treatment of Peri-Implantitis

Primary Purpose

Peri-implantitis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gauze
Titanium brush
Air powder abrasion
Comprehensive
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implantitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • PPD >6 mm
  • Positive BOP
  • Peri-implant marginal bone loss (MBL) >3 mm
  • Age: 18 to 75 years

Exclusion Criteria

  • Implant mobility
  • Smoking
  • Current cancer
  • Steroids use (last 2 years)
  • Bisphosphonates use (last 4 years)
  • Uncontrolled diabetes (HBA1c >7)
  • Other systemic conditions that affect wound healing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Group C

    Group D

    Arm Description

    Implant surface will be wiped with sterile gauze soaked alternatively in sterile saline and CHX (5 times)

    Titanium brush: Titanium brush (TiBrush, Straumann, Switzerland) mounted on an oscillating hand piece will be used for 1 minute.

    Air powder abrasion: One minute of air powder abrasion using Glycine prophy powder (Prophy Jet, Dentsply, USA) with overlapping passes form apical to coronal direction for 1 minute.

    A comprehensive treatment including the use of titanium brush and air powder abrasion (as described above) and 30 seconds etching with 9.6% HF acid gel (Premier, USA) applied with a micro-applicator tip (Unipack Medical, USA), followed by copious irrigation with sterile saline.

    Outcomes

    Primary Outcome Measures

    Bleeding on Probing (BOP)
    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
    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)
    Distance from the gingival margin to the depth of the pocket

    Secondary Outcome Measures

    Marginal bone loss
    Measurement from the implant platform to first bone-to-implant contact
    Inflammatory biomarkers
    Inflammatory biomarkers in the peri-implant crevicular fluid (PICF)
    Microbial profile
    Microbial profile in the peri-implant crevicular fluid (PICF)

    Full Information

    First Posted
    April 3, 2017
    Last Updated
    June 19, 2019
    Sponsor
    University of Southern California
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03114956
    Brief Title
    Surface Decontamination in Treatment of Peri-Implantitis
    Official Title
    Effects of Implant Surface Decontamination on Control of Peri-Implant Inflammation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not able to secure funding
    Study Start Date
    June 19, 2019 (Actual)
    Primary Completion Date
    June 19, 2019 (Actual)
    Study Completion Date
    June 19, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Southern California

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    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
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    The investigator who is analyzing the data will be blinded to the assigned groups to prevent bias.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Implant surface will be wiped with sterile gauze soaked alternatively in sterile saline and CHX (5 times)
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Titanium brush: Titanium brush (TiBrush, Straumann, Switzerland) mounted on an oscillating hand piece will be used for 1 minute.
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    Air powder abrasion: One minute of air powder abrasion using Glycine prophy powder (Prophy Jet, Dentsply, USA) with overlapping passes form apical to coronal direction for 1 minute.
    Arm Title
    Group D
    Arm Type
    Experimental
    Arm Description
    A comprehensive treatment including the use of titanium brush and air powder abrasion (as described above) and 30 seconds etching with 9.6% HF acid gel (Premier, USA) applied with a micro-applicator tip (Unipack Medical, USA), followed by copious irrigation with sterile saline.
    Intervention Type
    Procedure
    Intervention Name(s)
    Gauze
    Intervention Description
    Implant surface will be wiped with sterile gauze soaked alternatively in sterile saline and CHX (5 times)
    Intervention Type
    Procedure
    Intervention Name(s)
    Titanium brush
    Intervention Description
    Titanium brush: Titanium brush (TiBrush, Straumann, Switzerland) mounted on an oscillating hand piece will be used for 1 minute.
    Intervention Type
    Procedure
    Intervention Name(s)
    Air powder abrasion
    Intervention Description
    Air powder abrasion: One minute of air powder abrasion using Glycine prophy powder (Prophy Jet, Dentsply, USA) with overlapping passes form apical to coronal direction for 1 minute.
    Intervention Type
    Procedure
    Intervention Name(s)
    Comprehensive
    Intervention Description
    A comprehensive treatment including the use of titanium brush and air powder abrasion (as described above) and 30 seconds etching with 9.6% HF acid gel (Premier, USA) applied with a micro-applicator tip (Unipack Medical, USA), followed by copious irrigation with sterile saline.
    Primary Outcome Measure Information:
    Title
    Bleeding on Probing (BOP)
    Description
    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)
    Time Frame
    3 months
    Title
    Suppuration upon probing
    Description
    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)
    Time Frame
    3 months
    Title
    Probing Pocket Depth (PPD)
    Description
    Distance from the gingival margin to the depth of the pocket
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Marginal bone loss
    Description
    Measurement from the implant platform to first bone-to-implant contact
    Time Frame
    3 month
    Title
    Inflammatory biomarkers
    Description
    Inflammatory biomarkers in the peri-implant crevicular fluid (PICF)
    Time Frame
    3 months
    Title
    Microbial profile
    Description
    Microbial profile in the peri-implant crevicular fluid (PICF)
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 Smoking Current cancer Steroids use (last 2 years) Bisphosphonates use (last 4 years) Uncontrolled diabetes (HBA1c >7) Other systemic conditions that affect wound healing

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    At the end of the study, the clinical data and radiographs will be shared with other investigators included in this study for analysis.

    Learn more about this trial

    Surface Decontamination in Treatment of Peri-Implantitis

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