Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 43 for:    FLUORIDE ION AND TRICLOSAN

Triclosan Toothpaste as a Preventive Strategy of Mucositis in Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03241407
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Fernanda Vieira Ribeiro, Paulista University

Brief Summary:
The purpose of this trial was to determine the effect of a triclosan-containing toothpaste in the clinical parameters and in the profile of osteo-immunoinflammatory mediators in the peri-implant crevicular fluid (PICF) as a preventive therapy of peri-implant experimental mucositis in cigarette smokers

Condition or disease Intervention/treatment Phase
Dental Implants Cigarette Smoking Other: Placebo toothpaste Other: triclosan/copolymer/fluoride toothpaste Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 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: Effect of a Triclosan-containing Toothpaste as a Preventive Strategy of Peri-implant Experimental Mucositis in Cigarette Smokers: Clinical and Osteo-immunoinflammatory Response in a Randomized Crossover Study.
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : September 1, 2013
Actual Study Completion Date : April 30, 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.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.
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 placebo 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. 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.
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. 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.


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

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

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

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

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  • Patients should be smokers (more than 10 cigarettes/day, for at least 2 years),
  • 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
  • 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 and bleeding score < 20%.

Exclusion Criteria:

  • pregnancy
  • lactation
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241407


Locations
Layout table for location information
Brazil
School of Dentistry - Paulista University UNIP
São Paulo, SP, Brazil, 052
Sponsors and Collaborators
Paulista University

Layout table for additonal information
Responsible Party: Fernanda Vieira Ribeiro, Professor, Paulista University
ClinicalTrials.gov Identifier: NCT03241407     History of Changes
Other Study ID Numbers: Triclosan Mucositis Smoking
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Triclosan
Fluorides
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic 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