Triclosan Toothpaste as a Preventive Strategy of Mucositis in Smokers
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ClinicalTrials.gov Identifier: NCT03241407 |
Recruitment Status :
Completed
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
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Condition or disease | Intervention/treatment | Phase |
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Dental Implants Cigarette Smoking | Other: Placebo toothpaste Other: triclosan/copolymer/fluoride toothpaste | Not Applicable |

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 |

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.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.
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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 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.
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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. |
- 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.
- bleeding index [ Time Frame: 21 days ]scored using dichotomous index of mucosal marginal bleeding around implants
- 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;

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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 |
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.

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
Brazil | |
School of Dentistry - Paulista University UNIP | |
São Paulo, SP, Brazil, 052 |
Responsible Party: | Fernanda Vieira Ribeiro, Professor, Paulista University |
ClinicalTrials.gov Identifier: | NCT03241407 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |