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
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Sponsor:
Paulista University
Information provided by (Responsible Party):
Fernanda Vieira Ribeiro, Paulista University
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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 |

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 |
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Arm | Intervention/treatment |
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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.
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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.
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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 :
- bleeding index [ Time Frame: 21 days ]scored using dichotomous index of mucosal marginal bleeding around implants,
Secondary Outcome Measures :
- plaque index [ Time Frame: 21 days ]scored using a dichotomous plaque index along the mucosal margin around implants
- Position of the peri-implant margin [ Time Frame: 21 days ]distance from the stent to the bottom of the peri-implant pocket;
- Peri-implant probing depth [ Time Frame: 21 days ]calculated by deducting PPM from RCAL
- Relative clinical attachment level [ Time Frame: 21 days ]which was the distance from the stent to the bottom of the peri-implant pocket;
- 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.
No Contacts or Locations Provided
Responsible Party: | Fernanda Vieira Ribeiro, Professor, Paulista University |
ClinicalTrials.gov Identifier: | NCT03145610 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Mucositis Peri-Implantitis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases Periodontal Diseases Triclosan Fluorides |
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 |