Clinical Study to Investigate the Tooth Stain Removal Efficacy of Two Experimental Toothpastes Compared to a Standard Toothpaste When Used Twice Daily for 8 Weeks

NCT05459558 | Completed Results

• 1 other identifier: 300024
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the stain removal efficacy of 2 experimental anti-dentin hypersensitivity (DH) dentifrices with four and eight weeks twice daily use. A daily use, regular fluoride dentifrice will be included as a reference dentifrice.

Conditions

Oral Hygiene

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Total Modified Lobene Stain Index (MLSI) Score at Week 8

  Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. MLSI score= Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, where 0= area with no stain, 1= Stain covering up to one third of area and light intensity stain, 2= Stain covering up to two thirds of area and moderate intensity stain, 3= Stain covering more than two thirds of area and heavy intensity stain. MLSI score ranged from 0 to 9. Mean Total MLSI Score = Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the Week 8 value.

  Baseline and Week 8

Secondary Outcomes (5)

• Change From Baseline in Mean Total MLSI Score at Week 4

  Baseline and Week 4

• Change From Baseline in Mean Total MLSI Score at Weeks 4 and 8

  Baseline, Week 4 and Week 8

• Change From Baseline in Mean VITA Shade Score (Examiner Assessed) at Weeks 4 and 8

  Baseline, Week 4 and Week 8

• Change From Baseline in Mean Total MLSI Score in Gingival Sites, Interproximal Sites and Body Sites at Weeks 4 and 8

  Baseline, Week 4 and Week 8

• Change From Baseline in Mean MLSI (Area) and MLSI (Intensity) at Weeks 4 and 8

  Baseline, Week 4 and Week 8

Study Arms (3)

Experimental Dentifrice 1

EXPERIMENTAL

Randomized participants will brush their teeth with the experimental dentifrice (covering the entire length of the toothbrush), twice daily (morning and evening) for 2 minutes for 8 weeks.

Drug: Experimental Dentifrice 1

Experimental Dentifrice 2

EXPERIMENTAL

Randomized participants will brush their teeth with the experimental dentifrice (covering the entire length of the toothbrush), twice daily (morning and evening) for 2 minutes for 8 weeks.

Drug: Experimental Dentifrice 2

Reference Dentifrice

ACTIVE COMPARATOR

Randomized participants will brush their teeth with the Reference dentifrice (covering the entire length of the toothbrush), twice daily (morning and evening) for 2 minutes for 8 weeks.

Drug: Reference Dentifrice

Interventions

Experimental Dentifrice 1 DRUG

5 percent (%) potassium nitrate (KNO3) dentifrice with 1% alumina and 5% sodium tripolyphosphate (STP).

Experimental Dentifrice 1

Experimental Dentifrice 2 DRUG

5% KNO3 dentifrice with 1% alumina, 5% STP and 2% high cleaning silica.

Experimental Dentifrice 2

Reference Dentifrice DRUG

Regular Fluoride Dentifrice.

Reference Dentifrice

Eligibility Criteria

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

You may qualify if:

• Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• Participant who is willing and able to comply with scheduled visits, product usage requirements, study procedures and lifestyle restrictions.
• Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history (for example, a medical condition confirmed to be causing xerostomia),or upon oral examination, that would impact the participant's safety, wellbeing or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
• Participant with generally good oral health with:
• At least 16 natural (vital) teeth including 11 of the 12 anterior teeth.
• Facial surfaces of all anterior teeth (maxillary and mandibular) and lingual surfaces of anterior teeth (mandibular only) gradable for MLSI with no significant calculus or large restorations as judged by the clinical examiner.
• Presence of extrinsic dental stain (formed on the surface of the teeth) as determined from a gross visual examination which, in the opinion of the clinical examiner, originates from the diet and/or use of tobacco products.
• Facial surfaces of central and lateral maxillary incisors gradable for tooth shade (free of cervical margin defects and restorations which could impact assessment), as judged by the clinical examiner.
• Baseline Total MLSI (Area x Intensity) greater than or equal to (\>=)15 for the facial surfaces of the 12 anterior teeth.
• Baseline mean tooth shade (VITA Bleachedguide 3D-MASTER) \>=11 on the facial surfaces of the 4 maxillary incisors.

You may not qualify if:

• Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
• Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of study entry and/or during study participation or who has previously been enrolled in this study.
• Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• Participant who is pregnant (self-reported) or intending to become pregnant during the study.
• Participant who is breastfeeding.
• Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
• Participant who is unwilling or, in the opinion of the investigator or medically qualified designee, unable to comply with the requirements and/or lifestyle restrictions of the study.
• Participant with a recent history (within the last year) of alcohol or other substance abuse.
• Participant with Oral Soft Tissue (OST) examination findings at Screening which, in the opinion of the investigator, could interfere with the conduct of the study (for example, stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling.
• Participant using daily oral care products and/or taking daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with study outcomes, specifically:
• currently daily use of mouthwashes containing ingredients known to cause tooth stain (for example, chlorhexidine or cetylpyridinium chloride),
• past or current use of minocycline,
• use of tetracycline or doxycycline within 30 days of screening and/or during the study,
• medications known to cause tooth stain (for example, drugs or supplements containing metal ions known to increase enamel staining).
• Participant who has used any professionally-dispensed tooth whitening products 6 months prior to baseline or any over-the-counter products (including peroxide- or covarine blue-containing dentifrice, but not other daily use whitening dentifrices) 3 months prior to baseline.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

All Sum Research Center (c/o Family & Cosmetic Dentistry)

Melbourne, Florida, 32940, United States

Location

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+447880182593

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: September 15, 2022
• Primary Completion: December 4, 2022
• Study Completion: December 4, 2022
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be grant-ed, when justified, for up to another 12 months.

Locations

US (1)