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Impact of a Triclosan-containing Toothpaste During the Progression of Experimental Peri-implant Mucositis

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ClinicalTrials.gov Identifier: NCT03145610
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Fernanda Vieira Ribeiro, Paulista University

Brief Summary:
The aim of this study was to evaluate the influence of a triclosan-containing toothpaste in the profile of osteo-immunoinflammatory mediators in the peri-implant crevicular fluid (PICF) and in the clinical parameters during the progression of experimental peri-implant mucositis.

Condition or disease Intervention/treatment Phase
Biological Markers; Dental Implants; Cytokines; Triclosan; Toothpastes; Peri-Implantitis; Microbiology Other: Placebo toothpaste Other: triclosan/copolymer/fluoride toothpaste Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This investigation was designed as double-blind, randomized, crossover study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of a Triclosan-containing Toothpaste During the Progression of Experimental Peri-implant Mucositis: Clinical Parameters and Local Pattern of Osteo-immunoinflammatory Mediators in Peri-implant Fluid
Actual Study Start Date : June 1, 2013
Actual Primary Completion Date : May 30, 2014
Actual Study Completion Date : January 14, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo toothpaste
Fluoride toothpaste will be used by filling the individual silicone stent allowing it to come into contact with the implant area for 2 min.
Other: Placebo toothpaste
During an experimental 3-week period of undisturbed mechanical plaque accumulation in the implants, implants randomly assigned to Placebo group will be submitted to a chemical plaque control (three times per day) using a Triclosan toothpaste.

Experimental: triclosan/copolymer/fluoride toothpaste
triclosan/copolymer/fluoride toothpaste will be used by filling the individual silicone stent allowing it to come into contact with the implant area for 2 min.
Other: triclosan/copolymer/fluoride toothpaste
During an experimental 3-week period of undisturbed mechanical plaque accumulation in the implants, implants randomly assigned to triclosan/copolymer/fluoride group will be submitted to a chemical plaque control (three times per day) using a triclosan/copolymer/fluoride toothpaste.




Primary Outcome Measures :
  1. bleeding index [ Time Frame: 21 days ]
    scored using dichotomous index of mucosal marginal bleeding around implants,


Secondary Outcome Measures :
  1. plaque index [ Time Frame: 21 days ]
    scored using a dichotomous plaque index along the mucosal margin around implants

  2. Position of the peri-implant margin [ Time Frame: 21 days ]
    distance from the stent to the bottom of the peri-implant pocket;

  3. Peri-implant probing depth [ Time Frame: 21 days ]
    calculated by deducting PPM from RCAL

  4. Relative clinical attachment level [ Time Frame: 21 days ]
    which was the distance from the stent to the bottom of the peri-implant pocket;

  5. Osteo-immunoinflammatory mediators [ Time Frame: 21 days ]
    Levels of interferon (INF), interleukin (IL)-4, IL-17, IL-1β, IL-10, IL-6, IL-23, tumor necrosis factor (TNF)-α (Human Th17 HTH17MAG-14K, Millipore Corporation, Billerica, MA, USA), osteoprotegerin (OPG), osteocalcin (OC), osteopontin (OPN) (Human Bone HBNMAG-51K, Millipore Corporation, Billerica, MA, USA), matrix metalloproteinase (MMP)-2, MMP-9 (Human MMP Panel 2 HMMP2MAG-55K, Millipore Corporation, Billerica, MA, USA), transforming growth factor (TGF)-β (Multi-species TGFβ TGFBMAG-64K, Millipore Corporation, Billerica, MA, USA) and crosslinked telopeptide of type I collagen (ICTP) (Uscn Life Science Inc. Wuhan, Hubei, PRC) in the peri-implant fluid were determined using commercially available kits.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 30 years old or more
  • present at least a 2-stage unitary screwed implant-supported single-unit crown in the molar or pre-molar region
  • implant connection should be external hexagonal and the implants should be in function at least 12 months with width of keratinized tissue > 2mm around implants
  • The peri-implant tissue should be healthy [probing depth (PD) <4mm with no bleeding on probing (BoP) and no evidence of radiographic bone loss beyond bone remodeling (AAP 2013).
  • Patients should be periodontally healthy and present full mouth plaque scores (FMPS, Ainamo & Bay 1975) and bleeding score (FMBS, Muhlemann & Son 1971) < 20%.

Exclusion Criteria:

  • pregnancy
  • lactation
  • smokers
  • systemic conditions r that could affect the progression of peri-implant diseases and bone metabolism (e.g., immunologic disorders), use of long-term administration of anti-inflammatory and immunosuppressive medications
  • antibiotic therapies in the previous 6 months
  • individuals that required bone grafts before or alongside the implant surgery
  • history of previous regenerative procedures in the area treated with implant therapy.

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Responsible Party: Fernanda Vieira Ribeiro, Professor, Paulista University
ClinicalTrials.gov Identifier: NCT03145610     History of Changes
Other Study ID Numbers: Triclosan Mucositis
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Triclosan
Fluorides
Mucositis
Peri-Implantitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents