NCT03145610

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

12 months

First QC Date

April 27, 2017

Last Update Submit

May 8, 2017

Conditions

Biological Markers; Dental Implants; Cytokines; Triclosan; Toothpastes; Peri-Implantitis; Microbiology

Outcome Measures

Primary Outcomes (1)

  • bleeding index

    scored using dichotomous index of mucosal marginal bleeding around implants,

    21 days

Secondary Outcomes (5)

  • plaque index

    21 days

  • Position of the peri-implant margin

    21 days

  • Peri-implant probing depth

    21 days

  • Relative clinical attachment level

    21 days

  • Osteo-immunoinflammatory mediators

    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.

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.

Other: triclosan/copolymer/fluoride toothpaste

Interventions

Placebo toothpasteOTHER

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.

Placebo toothpaste
triclosan/copolymer/fluoride toothpasteOTHER

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

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Triclosan

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This investigation was designed as double-blind, randomized, crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 9, 2017

Study Start

June 1, 2013

Primary Completion

May 30, 2014

Study Completion

January 14, 2015

Last Updated

May 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share