The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis

Phase 3

Completed

• Conditions: Dental Plaque; Gingivitis
• Interventions: Drug: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash; Drug: fluoride toothpaste + fluoride Mouthwash; Drug: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

• Registration Number: NCT02193165
• Lead Sponsor: Colgate Palmolive

Brief Summary

The objective of this clinical research study is to assess the efficacy of three oral hygiene multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a mouthwash in controlling established dental plaque and gingivitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-17
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2014-11-14
• Results First Submitted QC: 2015-02-04
• Results First Posted: 2015-02-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Male and female subjects, ages 21-70, inclusive.
2. Availability for the six-week duration of the study.
3. Good general health.
4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
7. Signed Informed Consent Form.

Exclusion Criteria

1. Presence of orthodontic bands.
2. Presence of partial removable dentures.
3. Tumor(s) of the soft or hard tissues of the oral cavity.
4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5. Five or more carious lesions requiring immediate restorative treatment.
6. Use of antibiotics any time during the one month prior to entry into the study.
7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
8. Pregnant women or women who are breast feeding.
9. Dental prophylaxis received in the past two weeks prior to baseline examinations.
10. History of allergies to oral care/personal care consumer products or their ingredients.
11. On any prescription medicines that might interfere with the study outcome.
12. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
13. History of alcohol or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen 1	triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash	triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
Regimen 3 - Control group	fluoride toothpaste + fluoride Mouthwash	fluoride toothpaste + fluoride Mouthwash
Regimen 2	stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash	stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

Primary Outcome Measures

Name	Time	Method
Dental Plaque Scores	6 weeks	Dental Plaque (Quigley-Hein, Turesky Modification 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)
Gingivitis Scores	6 weeks	Gingivitis scale (Loe \& Silness Gingival 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)

Trial Locations

Locations (1)

Centro Comercial Plaza Trujillo; 🇵🇷 Trujillo Alto, Puerto Rico