A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

NCT00964860 | Completed Phase 3 Results

• 1 other identifier: 2009061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing gingivitis.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group

  Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation

  30 days

Secondary Outcomes (1)

• Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group

  30 days

Study Arms (2)

Brushing Only

NO INTERVENTION

Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice

Brushing + Flossing

EXPERIMENTAL

Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss

Device: Glide dental floss

Interventions

Glide dental floss DEVICE

Glide waxed dental floss

Brushing + Flossing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be included in the study, each subject must:
• be at least 18 years of age;
• be physically able to floss their teeth;
• have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included);
• have refrained from performing oral hygiene the morning of the Baseline visit;
• be in good general health;
• have interproximal MGI (Modified Gingival Index) score of \>2.8.

You may not qualify if:

• Subjects are excluded from study participation where there is evidence of:
• severe periodontal disease;
• discoloration or pigmentation in the gingival tissue;
• meaningful misalignment of front 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Radiologio Oral Y Maxilofacial

Guatemala City, Zone 9, Guatemala

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Holly Eynon
• Organization: Procter and Gamble

eynon.ha@pg.com

513-622-2920

Study Officials

• Jon Witt, PhD

  Procter and Gamble

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 25, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 31, 2012
• Results First Posted: October 31, 2012

Record last verified: 2012-10

Locations

GU (1)