Compare the Clinical Efficacy of Prototype Toothpastes.

Gingival Diseases Clinical Trial

Official title:

Compare the Clinical Efficacy of Prototype Toothpastes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761930
• Other study ID #: CRO-2007-GIN-04-RR
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: August 8, 2013
• Start date: March 2008
• Est. completion date: June 2008

Study information

• Verified date: August 2013
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 2008
• Est. primary completion date: June 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 16 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.

• Dental Selection Criteria: Average full mouth GI score should be in the range of

• - 2.0. heavy plaque formers should be avoided. Target a full mouth PI

• (Quigley-Hein) to be in the range of 1.5-3.0

• If of child bearing potential and on birth control (diaphragm, birth control pills,

• Birth control implants, IUD (Intrauterine device), condoms)

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

• 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 are 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.

• Use of tobacco products

• Subjects who must receive dental treatment during the study dates.

• Current use of Antibiotics for any purpose.

• History of allergy to common dentifrice ingredients

• Presence of an orthodontic appliance which interferes with plaque scoring.

• History of allergy to natural remedies, such as herbal ingredients

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

• Smoker

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 and fluoride
Brush twice daily
• Herbal Ingredient and fluoride
Brush twice daily

Locations

Country	Name	City	State
United States	Eastman Dental Center - University of Rochester	Rochester	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	Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.	6 weeks	No
Primary	Gingivitis Score	Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,; 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.	6 weeks	No
Primary	Bleeding Index (EIBI)	Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.	6 weeks	No