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

NCT06244303 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2023-11-PG-DWN-CA-BGS
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gingivitis; Plaque

Keywords

Loe and Silness Gingival Index; Quigley and Hein Plaque Index

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group I

ACTIVE COMPARATOR

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)

Group II

PLACEBO COMPARATOR

Manual Toothbrush +Colgate Great Regular Flavor Toothpaste Brush w/ full ribbon, 2x day / 2mins

Drug: manual toothbrush + Colgate dental cream

Interventions

manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F) DRUG

Toothpaste, toothbrush \& mouthwash regime

Group I

manual toothbrush + Colgate dental cream DRUG

toothpaste + toothbrush

Group II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Presence of orthodontic appliances.
• Presence of partial removable dentures.
• Tumor(s) of the soft or hard tissues of the oral cavity.
• 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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Mesa Dental Centre

Costa Mesa, California, 92627, United States

Location

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Farid Ayad, B.D.S., D.D.S., MSC

  FAR Oral and Systemic Health Consulting, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: January 22, 2024
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)