Clinical Research Study to Evaluate the Stain Removal Efficacy

NCT06242769 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2020-04-STN-SNF-PR-BGS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.

Conditions

Tooth Stain Removal

Keywords

Composite Lobene; extrinsic stain

Outcome Measures

Primary Outcomes (1)

• Composite Lobene Stain Index

  subjects will be evaluated for tooth stain by the dental examiner

  measurement at baseline, 3 week & 6 week

Study Arms (2)

Group I

ACTIVE COMPARATOR

Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min

Drug: Stannous Fluoride Toothpaste (SnF); Drug: Colgate Fluoride Toothpaste (CDC)

Group II

PLACEBO COMPARATOR

Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min

Drug: Stannous Fluoride Toothpaste (SnF); Drug: Colgate Fluoride Toothpaste (CDC)

Interventions

Stannous Fluoride Toothpaste (SnF) DRUG

test

Group I; Group II

Colgate Fluoride Toothpaste (CDC) DRUG

negative control

Group I; Group II

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Good general health
• Male and female subjects, aged 21-70, inclusive
• Present 12 scoreable natural anterior teeth
• A minimum mean Composite Lobene Index score of 1 or greater
• Available for the duration of the study
• Clinical evidence of a tendency to form extrinsic stain on anterior teeth

You may not qualify if:

• Presence of orthodontic bands
• Presence of partial removable dentures
• Tumor(s) of the soft or hard tissues of the oral cavity
• Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
• Five or more carious lesions requiring immediate restorative treatment
• Use of antibiotics or stain inducing medications any time during the one month 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
• Self-reported pregnancy and/or women who are breast feeding
• Dental prophylaxis received in the past four weeks prior to baseline examinations
• History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide
• On any prescription medicines that might interfere with the study outcome
• History of alcohol and/or drug abuse
• Exposed to a tooth whitening procedure during the last 3 months

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Dental Research Associates, Inc.

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Interventions

Centers for Disease Control and Prevention, U.S.

Intervention Hierarchy (Ancestors)

United States Public Health Service; United States Dept. of Health and Human Services; United States Government Agencies; Federal Government; Government; Organizations; Health Care Economics and Organizations

Study Officials

• Augusto R Elias-Boneta, DMD, MSD

  Dental Research Associates, Inc

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: July 27, 2020
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

PR (1)