Triclosan Toothpaste as a Preventive Strategy of Mucositis in Smokers

NCT03241407 | Completed DMC

• 1 other identifier: Triclosan Mucositis Smoking
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Implants; Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Osteo-immunoinflammatory mediators

  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.

  21 days

Secondary Outcomes (5)

• bleeding index

  21 days

• plaque index

  21 days

• Position of the peri-implant margin

  21 days

• Peri-implant probing depth

  21 days

• Relative clinical attachment level

  21 days

Study Arms (2)

Placebo toothpaste

PLACEBO COMPARATOR

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

triclosan/copolymer/fluoride toothpaste

EXPERIMENTAL

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

Interventions

Placebo toothpaste OTHER

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.

Placebo toothpaste

triclosan/copolymer/fluoride toothpaste OTHER

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.

triclosan/copolymer/fluoride toothpaste

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paulista University: lead

Study Sites (1)

School of Dentistry - Paulista University UNIP

São Paulo, São Paulo, 052, Brazil

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Triclosan

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This investigation was designed as double-blind, randomized, crossover study

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: April 30, 2015
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)