Efficacy of Manual Toothbrushes in Removing Tooth Stains

NCT06486974 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2024-08-STN-DRW-DR-BGS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.

Conditions

Tooth Discoloration

Keywords

Lobene Tooth Stain Index

Outcome Measures

Primary Outcomes (1)

• Lobene Tooth Stain Index

  Each tooth will be scored separately using a 4 point area Stain Area (extent): (0) No stain detected 1. Stain covering up to one third (1/3) of the region 2. Stain covering \> 1/3 to 2/3 of the region 3. Stain covering \> 2/3 of the region Stain Intensity: (0) No stain 1. Light Stain - yellow to light brown or gray 2. Moderate stain - medium brown 3. Heavy stain - dark brown to black and intensity scale ranging from: Using the Lobene Tooth Stain Index, each tooth will be scored separately using a 4 point area and intensity scale ranging from:

  Baseline, and 6-weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Colgate MaxFresh Toothpaste - 0.243% NaF (1100 ppm F) Total Polish 23 CHS TB Colgate Active Prevention Manual Toothbrush

Drug: NaF

Group 2

ACTIVE COMPARATOR

Colgate Great Regular Flavor Toothpaste - 0.76% Na MFP (1000 ppm F) Colgate Adult Extra Clean soft-bristle toothbrush

Drug: Na MFP

Interventions

Na MFP DRUG

Group 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study

Group 2

NaF DRUG

Group 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study

Group 1

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, inclusive;
• Good general health and good oral health based on the opinion of the study investigator;
• Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures);
• A minimum composite mean of 1.5 ≥ determined by the Lobene Tooth Stain Index;
• Available for the duration of the study;
• Clinical evidence of a tendency to form extrinsic stains on anterior teeth.

You may not qualify if:

• Presence of orthodontic appliances/retainers involving scorable teeth;
• Presence of partial removable/fixed dentures and/or restorations involving scorable teeth;
• Tumor(s) of the soft or hard tissues of the oral cavity;
• Five or more carious lesions requiring immediate care;
• Use of antibiotics, stain-inducing medications, and/or on any prescription that might interfere with the study outcome;
• Concurrent participation in another clinical study;
• Self-reported pregnancy and/or lactating women;
• Have used professional whitening product within one (1) year or had a dental prophylaxis (professional dental cleaning) within thirty (30) days - prior to the start of the study;
• History of allergies to oral care/personal care consumer products or their ingredients;
• History of alcohol and/or drug abuse.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Spa Dental

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Supersmile

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Franklin Garcia-Godoy, DDS, MS, PhD

  Global Research Consultants

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: September 23, 2024
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: March 19, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)