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Evaluate Clinical Research From Commerical Oral Care Products

Primary Purpose

Gingival Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluoride
Triclosan/Fluoride
Chlorhexidine Gluconate
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female volunteers 18-65 years of age
  • Good general health
  • Must sign informed consent form
  • Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
  • No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

  • Subjects unable or unwilling to sign the informed consent form.
  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Moderate or advanced periodontal disease or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions
  • 2 or more decayed untreated dental sites at screening.
  • Other disease of the hard or soft oral tissues.
  • Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  • Use of medications that can currently affect salivary flow.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 1 week prior to enrollment into this study.
  • Allergy to chlorhexidine
  • Use of tobacco products
  • Subjects who must receive dental treatment during the study dates.
  • Current use of Antibiotics for any purpose.
  • Presence of an orthodontic appliance.
  • History of allergy to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Sites / Locations

  • Boston University School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Dental Plaque Index
Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)

Secondary Outcome Measures

Full Information

First Posted
September 23, 2008
Last Updated
February 24, 2010
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT00759187
Brief Title
Evaluate Clinical Research From Commerical Oral Care Products
Official Title
Evaluate Clinical Research From Commerical Oral Care Products
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Colgate Palmolive

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.
Detailed Description
The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fluoride
Other Intervention Name(s)
monofluorophosphate
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Triclosan/Fluoride
Other Intervention Name(s)
sodium fluoride, triclosan
Intervention Description
Half mouth toothbrushing twice daily for 4 days
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine Gluconate
Other Intervention Name(s)
Chlorhexidine Gluconate oral rinse
Intervention Description
Mouth rinsing twice a day for 4 days
Primary Outcome Measure Information:
Title
Dental Plaque Index
Description
Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)
Time Frame
4-Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female volunteers 18-65 years of age Good general health Must sign informed consent form Minimum of 20 natural uncrowned teeth (excluding third molars) must be present. No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study. Exclusion Criteria: Subjects unable or unwilling to sign the informed consent form. Medical condition which requires pre-medication prior to dental visits/procedures Moderate or advanced periodontal disease or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions 2 or more decayed untreated dental sites at screening. Other disease of the hard or soft oral tissues. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation). Use of medications that can currently affect salivary flow. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. Pregnant or nursing women. Participation in any other clinical study within 1 week prior to enrollment into this study. Allergy to chlorhexidine Use of tobacco products Subjects who must receive dental treatment during the study dates. Current use of Antibiotics for any purpose. Presence of an orthodontic appliance. History of allergy to common dentifrice ingredients. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Van Dyke, DDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

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Evaluate Clinical Research From Commerical Oral Care Products

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