NCT01799226

Brief Summary

This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental gingivitis model developed by Löe et al. Half of the participants will use Colgate Total® (which contains triclosan), while the other half will use a toothpaste which does not contain triclosan as the control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 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

First Submitted

Initial submission to the registry

February 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 13, 2016

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

February 24, 2013

Results QC Date

July 23, 2015

Last Update Submit

January 11, 2016

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35

    Silness \& Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.

    Baseline to 35 Days

Secondary Outcomes (1)

  • Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35

    Baseline to 35 Days

Other Outcomes (3)

  • Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression.

    Baseline to 35 Days

  • Plaque Samples Will be Collected for Bacterial Species Detection.

    Baseline to 35 Days

  • Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression.

    Baseline to 35 Days

Study Arms (2)

Toothpaste without Triclosan

ACTIVE COMPARATOR

This arm will use a toothpaste that does not contain triclosan

Other: Toothpaste without triclosan

Triclosan

EXPERIMENTAL

This arm will use colgate total which contains triclosan

Other: Triclosan

Interventions

Toothpaste without triclosanOTHER

this intervention will use a toothpaste without triclosan

Toothpaste without Triclosan
TriclosanOTHER

this intervention will use Colgate Total which contains triclosan

Also known as: Colgate total toothpaste
Triclosan

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Race - all
  • Gender - female or male
  • Age - 18 to 40 years old
  • Dentition - minimum of 20 permanent teeth
  • Probing Pocket Depth of 1-4mm in all sites
  • Mean Clinical Attachment Levels of 2mm on all teeth
  • Bleeding Upon Probing of greater than 30% at Day -14 Study Visit
  • Consent Form - read, understood, and signed
  • Study Procedures - willing to follow all study procedures
  • BOP less than 10% at the second assessment visit will be exited from the
  • study

You may not qualify if:

  • Medical History - a history of alcoholism or drug abuse
  • Diseases of the immune system
  • Medical condition that may affect outcome (neurologic or psychiatric disorders, systemic infection
  • Medications - chronic medications known to affect the periodontal status (calcium antagonists anticonvulsives, immunosuppressives, anti-inflammatory medications, phenytoin, Depo-Provera contraceptive injection users
  • New oral contraceptives users within 3 months of baseline or are planning on starting oral contraceptives during the study
  • Hypersensitivity - previous known reaction to or oral allergy to any ingredient in the study toothpaste
  • Antibiotics - antibiotic therapy within 3 months of baseline visit
  • antibiotic therapy needed for infective endocarditis prophylaxis or total joint replacement
  • Use of antiseptics - homecare regime using products to control dental plaque formation within 30 days prior to baseline visit
  • Smoking - current smokers, smokers who quit smoking less than one year ago, or a pack-year history of more than or equal to 10 (pack-years will be calculated by multiplying the number of years smoked by the average number of cigarette packs smoked per day)
  • Continine - positive urine analysis results
  • Current Dental Treatment - orthodontic or periodontal treatment
  • Untreated Dental Treatment - untreated carious lesions
  • Defective restorations which could exacerbate during a period of oral hygiene abstinence
  • Pregnant or women breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

  • Pancer BA, Kott D, Sugai JV, Panagakos FS, Braun TM, Teles RP, Giannobile WV, Kinney JS. Effects of triclosan on host response and microbial biomarkers during experimental gingivitis. J Clin Periodontol. 2016 May;43(5):435-44. doi: 10.1111/jcpe.12519. Epub 2016 Apr 6.

    PMID: 26820239DERIVED

MeSH Terms

Conditions

Gingivitis

Interventions

ToothpastesTriclosanhydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

DentifricesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgriculturePhenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Janet Kinney
Organization
UMichigan
kinneyj@umich.edu
734-615-5452

Study Officials

  • Janet Kinney, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Dentistry, Director of Dental Hygiene Program

Study Record Dates

First Submitted

February 24, 2013

First Posted

February 26, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 13, 2016

Results First Posted

January 13, 2016

Record last verified: 2016-01

Locations

US(1)