NCT01292343

Brief Summary

Triclosan containing dentifrices are effective in the prevention of inflammatory complications following third molar surgery through reducing preoperative oral bacteria load.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

5 years

First QC Date

February 4, 2011

Last Update Submit

October 26, 2015

Conditions

Dry SocketWound Infection

Keywords

third molarstriclosantoothpastedry socketwound infection

Outcome Measures

Primary Outcomes (1)

  • dry socket

    Development of dry socket (alveolar osteitis) 3 to 7 days after tooth extraction

    3 to 7 days

Secondary Outcomes (1)

  • wound infection

    3 to 7 days

Interventions

Colgate Total ToothpasteOTHER

Toothbrushing with Colgate Total Toothpaste

Also known as: triclosan, dentifrice
Colgate Regular ToothpasteOTHER

Toothbrushing with Colgate regular toothpaste

Also known as: fluoride, dentifrice

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • must include at least one mandibular third molar with partial or full bony impaction
  • no sign of active pericoronal (around the crown) infections
  • must have not taken antibiotics for any reason in the past 30 days
  • must be healthy and between 18 and 35 years of age
  • must be able to read and sign an informed consent

You may not qualify if:

  • Subjects with systemic diseases and pregnant or lactating women
  • Subjects with advanced periodontal diseases or having two or more untreated caries lesions
  • Subjects who cannot read and sign an informed consent
  • Subjects with signs of pericoronal infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Eastman Dental Center

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Dry SocketWound Infection

Interventions

hydrated silica gel-based toothpasteTriclosanDentifricesFluorides

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfections

Intervention Hierarchy (Ancestors)

Phenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBiomedical and Dental MaterialsCosmeticsSpecialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and AgricultureAnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine Compounds

Study Officials

  • Yanfang Ren, DDS, MPH

    University of Rochester Eastman Dental Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 4, 2011

First Posted

February 9, 2011

Study Start

February 1, 2008

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

US(1)