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

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gingivitis; Plaque
• Intervention / Treatment: Drug: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F); Drug: manual toothbrush + Colgate dental cream

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92627
      • Mesa Dental Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F) Brush 2 x day / 2 mins Colgate Total Mouthwash (CPC+Zn) Swish 20 mL / 30 secs	Drug: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F); Toothpaste, toothbrush & mouthwash regime; Drug: manual toothbrush + Colgate dental cream; toothpaste + toothbrush
Placebo Comparator: Group II; Manual Toothbrush +Colgate Great Regular Flavor Toothpaste Brush w/ full ribbon, 2x day / 2mins	Drug: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F); Toothpaste, toothbrush & mouthwash regime; Drug: manual toothbrush + Colgate dental cream; toothpaste + toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quigley and Hein Plaque Index	reductions in dental plaque	Baseline, 1-, 3-, 6-, and 12-week
Loe and Silness Gingival Index	reductions in gingivitis	Baseline, 1-, 3-, 6-, and 12-week

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Farid Ayad, B.D.S., D.D.S., MSC, FAR Oral and Systemic Health Consulting, Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): April 16, 2024
• Study Completion (Estimated): April 16, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Loe and Silness Gingival Index; Quigley and Hein Plaque Index
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Dental Deposits; Gingivitis; Dental Plaque; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Sodium Fluoride
• Other Study ID Numbers: CRO-2023-11-PG-DWN-CA-BGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes