Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

Gingivitis Clinical Trial

Official title:

Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926328
• Other study ID #: CRO-0507-PL-SP-CT-BS
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: August 8, 2013
• Start date: June 2007
• Est. completion date: December 2007

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

The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Availability for the six-month duration of the study.

• Good general health.

• Minimum of 20 uncrowned permanent natural teeth (excluding third molars).

• Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.

• Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).

• Signed Informed Consent Form.

Exclusion Criteria:

• Presence of orthodontic bands.

• Presence of partial removable dentures.

• Tumor(s) of the soft or hard tissues of the oral cavity.

• Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of

• periodontal attachment or alveolar bone).

• Five or more carious lesions requiring immediate restorative treatment.

• Use of antibiotics any time during the one month prior to entry into the study.

• Participation in any other clinical study or test panel within the one month prior to entry

• into the study.

• Pregnant women or women who are breast feeding.

• Receive a dental prophylaxis in the past two weeks prior to baseline examinations.

• History of allergic to personal care/consumer products or their ingredients.

• Taking any prescription medicines. That might interfere with the study outcome.

• Individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.

Study Design

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

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Triclosan, fluoride
Six Month study, brush twice daily
• Fluoride
twice daily usage

Locations

Country	Name	City	State
Spain	Dr. Fernando Autran	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingivitis Index	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)	6 months	No
Primary	Plaque Index	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)	6 Months	No