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

NCT ID: NCT02193165

Last Updated: 2015-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-08-31

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.

Conditions

Dental Plaque; Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Regimen 1

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

Group Type: ACTIVE_COMPARATOR

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

Intervention Type: DRUG

Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

Regimen 2

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

Group Type: ACTIVE_COMPARATOR

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

Intervention Type: DRUG

Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

Regimen 3 - Control group

fluoride toothpaste + fluoride Mouthwash

Group Type: PLACEBO_COMPARATOR

fluoride toothpaste + fluoride Mouthwash

Intervention Type: DRUG

Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Interventions

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

Intervention Type: DRUG

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

Intervention Type: DRUG

fluoride toothpaste + fluoride Mouthwash

Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Intervention Type: DRUG

Other Intervention Names

Total toothpaste; Total Mouthwash; Crest Pro-Health toothpaste; Crest Pro-Health Multi-Protection Mouthwash; Crest Cavity Protection toothpaste; Crest Pro-Health For Me Breezy Mint mouthwash

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Comercial Plaza Trujillo

Trujillo Alto, , Puerto Rico

Countries

Puerto Rico

Other Identifiers

CRO-2014-07-PG-REG-PR-BS

Identifier Type: -

Identifier Source: org_study_id