Evaluate Clinical Research From Commerical Oral Care Products

Gingival Diseases Clinical Trial

Official title:

Evaluate Clinical Research From Commerical Oral Care Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759187
• Other study ID #: CRO-0607-PLA-11-RR
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2008
• Last updated: February 24, 2010
• Start date: January 2008
• Est. completion date: April 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

The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.

Description:

The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases

Intervention

Drug:
• Fluoride
Brush twice daily
• Triclosan/Fluoride
Half mouth toothbrushing twice daily for 4 days
• Chlorhexidine Gluconate
Mouth rinsing twice a day for 4 days

Locations

Country	Name	City	State
United States	Boston University School of Dental Medicine	Boston	Massachusetts

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	Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)	4-Day	No