Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Plaque and Gingivitis.

Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Established Plaque and Gingivitis: a 6-week Clinical Study

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, and 6, weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study

Study Overview

• Status: Completed
• Conditions: Gingivitis; Plaque, Dental
• Intervention / Treatment: Drug: Test regimen; Drug: Control regimen

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Melbourne, Florida, United States, 32940
      • Consumer Research Consulting, LLC

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 six-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 mean plaque index of at least 0.6 as determined by Navy Plaque index.

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: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test regimen; Brush with full ribbon toothpaste, 2x day / 2mins with paste & toothbrush provided	Drug: Test regimen; toothpaste & manual toothbrush
Active Comparator: Control regimen; Brush with full ribbon toothpaste, 2x day / 2mins with paste & toothbrush provided	Drug: Control regimen; toothpaste & manual toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque assessment	The dentition will be disclosed with disclosing solution and plaque scored according to the Refined Navy Plaque Index. Refinement of the Navy plaque index to increase plaque scoring efficiency in gum line and interproximal tooth areas.	Initial reading, reading taken immediately following first brushing, 1-week, 3-weeks, and 6-weeks
Gingivitis Assessment	A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror.	Initial reading, 1-week, 3-weeks, and 6-weeks

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: John Gallob, DMD, Consumer Research Consulting, LLC.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Actual): September 10, 2024
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Infections; Gingival Diseases; Dental Deposits; Dental Plaque; Gingivitis
• Other Study ID Numbers: CRO-2024-04-MTB-FL-DR

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