Clinical Study to Evaluate Dental Plaque

Gingival Diseases Clinical Trial

Official title:

Clinical Study to Evaluate Dental Plaque

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758290
• Other study ID #: CRO-2008-PLA-13-RR
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2008
• Last updated: November 20, 2008
• Start date: May 2008
• Est. completion date: July 2008

Study information

• Verified date: November 2008
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 51 Years

Eligibility

Inclusion Criteria:

• Male or female volunteers at least 20 - 51 years of age

• Good general health

• Must sign informed consent form

• Minimum of 15 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)

• 5 or more decayed untreated dental sites at screening (cavities)

• 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 are currently affecting salivary function

• 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

• 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 which interferes with plaque scoring

• History of allergy to common toothpaste ingredients

• History of allergy to arginine (amino acid)

• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Plaque
• Gingival Diseases
• Periodontal Diseases

Intervention

Drug:
• Triclosan/Fluoride
Brush twice daily for 3 weeks
• Fluoride/triclosan
Brush daily for 3 weeks

Locations

Country	Name	City	State
United States	Bluestone Center for Clinical Research, NYU College of Dentistry	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental Plaque Index		4 Day	No