Clinical Research Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis.

Gingivitis Clinical Trial

Official title:

Clinical Research Study to Assess the Efficacy of Two Brushing Regimens: 1) a Toothpaste Containing Stannous Fluoride With a Mouthwash Containing Cetylpyridinium Chloride and a Manual Toothbrush as Compared to 2) a Regular Fluoride Toothpaste and Standard Manual Toothbrush in the Reduction of Established Dental Plaque and Gingivitis.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06244303
• Other study ID #: CRO-2023-11-PG-DWN-CA-BGS
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 22, 2024
• Est. completion date: April 16, 2024

Study information

• Verified date: January 2024
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1-, 3-, 6-, and 12-weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: April 16, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Signed Informed Consent Form.

• Male and female subjects aged 18-70 years, inclusive.

• Availability for the twelve-week duration of the clinical research study.

• Good general health based on the opinion of the study investigator

• Minimum of 20 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)

Exclusion Criteria:

• Presence of orthodontic appliances.

• Presence of partial removable dentures.

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

• Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.

• Five or more carious lesions requiring immediate restorative treatment.

• Antibiotic use any time during the one-month period 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.

• Dental prophylaxis during the past two weeks prior to baseline examinations.

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

• On any prescription medicines that might interfere with the study outcome.

• An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.

• History of alcohol and/or drug abuse.

• Self-reported pregnancy and/or lactating subjects

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis
• Plaque

Intervention

Drug:
• manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)
Toothpaste, toothbrush & mouthwash regime
• manual toothbrush + Colgate dental cream
toothpaste + toothbrush

Locations

Country	Name	City	State
United States	Mesa Dental Centre	Costa Mesa	California

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quigley and Hein Plaque Index	reductions in dental plaque	Baseline, 1-, 3-, 6-, and 12-week
Primary	Loe and Silness Gingival Index	reductions in gingivitis	Baseline, 1-, 3-, 6-, and 12-week