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Investigation of Dental Plaque and Gingival Index

Primary Purpose

Dental Plaque

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Sodium Monofluorophosphate

Triclosan/Fluoride/Copolymer

About this trial

This is an interventional treatment trial for Dental Plaque

Eligibility Criteria

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

Inclusion Criteria:

Be aged 18 to 65 years inclusive
Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
Give written informed consent
Be in good general health
Must discontinue oral hygiene for 24-hrs.after initial appointment.
No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

Medical condition which requires pre-medication prior to dental visits/procedures
Advanced periodontal disease
5 or more decayed, untreated dental sites
Diseases of the soft or hard oral tissues
Orthodontic appliances
Abnormal salivary function
Use of drugs that can currently affect salivary flow
Use of antibiotics one (1) month prior to or during this study
Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn)
Pregnant or breastfeeding.
Participation in another clinical study in the month preceding this study
Allergic 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 Type

Placebo Comparator

Active Comparator

Arm Label

A - Marketed fluoride toothpaste

B -Triclosan/NaF/CoPolymer toothpaste

Arm Description

Outcomes

Primary Outcome Measures

Gingival Margin Plaque Index

Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT00759031

First Posted

September 23, 2008

Last Updated

April 11, 2012

Sponsor

Colgate Palmolive

1. Study Identification

Unique Protocol Identification Number

NCT00759031

Brief Title

Investigation of Dental Plaque and Gingival Index

Official Title

Investigation of Dental Plaque and Gingival Index

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Colgate Palmolive

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.

6. Conditions and Keywords

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

Dental Plaque

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A - Marketed fluoride toothpaste

Arm Type

Placebo Comparator

Arm Title

B -Triclosan/NaF/CoPolymer toothpaste

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Sodium Monofluorophosphate

Other Intervention Name(s)

Colgate Great Regular Flavor toothpaste

Intervention Description

Brush teeth and evaluate plaque score after one use of the study toothpaste

Intervention Type

Drug

Intervention Name(s)

Triclosan/Fluoride/Copolymer

Other Intervention Name(s)

Colgate Total toothpaste

Intervention Description

Brush teeth and evaluate plaque score after one use of the study toothpaste

Primary Outcome Measure Information:

Title

Gingival Margin Plaque Index

Description

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be aged 18 to 65 years inclusive Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present Give written informed consent Be in good general health Must discontinue oral hygiene for 24-hrs.after initial appointment. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study Exclusion Criteria: Medical condition which requires pre-medication prior to dental visits/procedures Advanced periodontal disease 5 or more decayed, untreated dental sites Diseases of the soft or hard oral tissues Orthodontic appliances Abnormal salivary function Use of drugs that can currently affect salivary flow Use of antibiotics one (1) month prior to or during this study Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn) Pregnant or breastfeeding. Participation in another clinical study in the month preceding this study Allergic to common dentifrice ingredients. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia Corby, DDS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston University School of Dental Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Investigation of Dental Plaque and Gingival Index

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