Investigation of Dental Plaque and Gingival Index

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT00759031

First received: September 23, 2008

Last updated: April 11, 2012

Last verified: April 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
Dental Plaque	Drug: Sodium Monofluorophosphate Drug: Triclosan/Fluoride/Copolymer	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment
Official Title:	Investigation of Dental Plaque and Gingival Index

Resource links provided by NLM:

Drug Information available for: Triclosan Sodium monofluorophosphate

U.S. FDA Resources

Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:

Gingival Margin Plaque Index [ Time Frame: 1 day ]
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.


Enrollment:	19
Study Start Date:	February 2008
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: A - Marketed fluoride toothpaste	Drug: Sodium Monofluorophosphate Brush teeth and evaluate plaque score after one use of the study toothpaste Other Name: Colgate Great Regular Flavor toothpaste
Active Comparator: B -Triclosan/NaF/CoPolymer toothpaste	Drug: Triclosan/Fluoride/Copolymer Brush teeth and evaluate plaque score after one use of the study toothpaste Other Name: Colgate Total toothpaste

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759031

Locations


United States, New York
Boston University School of Dental Medicine
New York, New York, United States, 10016

Sponsors and Collaborators

Colgate Palmolive

Investigators


Principal Investigator:	Patricia Corby, DDS

More Information


Responsible Party:	Colgate Palmolive
ClinicalTrials.gov Identifier:	NCT00759031 History of Changes
Other Study ID Numbers:	CRO-2007-PLA-23-RR
Study First Received:	September 23, 2008
Results First Received:	October 16, 2008
Last Updated:	April 11, 2012

Additional relevant MeSH terms:


Dental Plaque Dental Deposits Tooth Diseases Stomatognathic Diseases Fluorides Fluorophosphate Sodium Fluoride Triclosan Listerine Cariostatic Agents	Protective Agents Physiological Effects of Drugs Anti-Infective Agents, Local Anti-Infective Agents Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 19, 2017

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