A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Gingivitis Clinical Trial

Official title:

A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855933
• Other study ID #: 2008110
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2009
• Last updated: January 7, 2013
• Start date: January 2009
• Est. completion date: February 2009

Study information

• Verified date: January 2013
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in healthy adults with mild-to-moderate gingivitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years of age;

• physically able to floss his/her teeth;

• refrained from performing oral hygiene the morning of the Baseline visit;

• have measurable gingivitis on at least 5 test sites;

• in good general health.

Exclusion Criteria:

• severe periodontal disease

• atypical discoloration or pigmentation in the gingival tissue;

• meaningful malocclusion of the anterior teeth;

• fixed facial orthodontic appliances;

• use of antibiotics within two weeks of the baseline visit and at any time during the study;

• any diseases or conditions that could be expected to interfere with the subject safely completing the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• Experimental Floss
Experimental Glide® floss with cetylpyridinium chloride (~13% dry weight CPC)

Locations

Country	Name	City	State
Guatemala	Luis R. Archila, DDS	Guatemala City
United States	Dr. Geza Terézhalmy, DDS , MA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Countries where clinical trial is conducted

United States,  Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale	A whole-mouth average Lobene Modified Gingival Index was calculated by summing the scores and dividing by the number of sites graded (excludes missing teeth & sites not graded). Whole mouth average can range from 0 (normal) to 4 (severe inflammation).; For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored using the following scale: 0=Normal (Absence of inflammation, 1=Mild inflammation (slight change in color, little change in texture) of any portion of but not the entire marginal or papillary gingival unit, 2=Mild inflammation criteria as above but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingival unit, 4=Severe inflammation (marked redness, edema and/or hypertrophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.	4 weeks	No