A Study to Investigate the Tooth Whitening and Dentin Hypersensitivity Effectiveness of Two Experimental Toothpastes

NCT07297732 | Completed

• 1 other identifier: 300292
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this exploratory clinical study is to investigate the tooth whitening potential, Dentin Hypersensitivity (DH) efficacy, and oral tolerability of two experimental toothpastes in a DH population with appropriate tooth shade and dental stain levels for the evaluation of whitening performance.

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• Mean VITA Shade Score at Baseline, Weeks 1, 2, 4 and 8

  Tooth color of the facial surfaces of the six anterior maxillary teeth will be visually assessed using the VITA Bleachedguide 3D-MASTER shade guide. It consists of a value-ranked ordered scale from 1 (lightest) to 29 (darkest). The shade of each assessable tooth surface/region will be scored by the clinical examiner with reference to the guide, where lower score indicates improvement.

  Baseline, Weeks 1, 2, 4 and 8

• Mean Total Modified Lobene Stain Index (MLSI) Score at Baseline, Weeks 1, 2, 4 and 8

  Dental stain will be visually assessed for the facial surfaces of the teeth (incisors and canines) using the MLSI. For each tooth surface assessed, Area (A) and Intensity (I) of dental stain will be scored separately on the scale of 0 to 3 and the mean total score will be presented, 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. Total MLSI score = Area score multiplied by Intensity score and ranging from 0 to 9, where lower score indicates improvement.

  Baseline, Weeks 1, 2, 4 and 8

Secondary Outcomes (2)

• Schiff Sensitivity Score at Baseline, Week 4 and Week 8

  Baseline, Week 4 and 8

• Tactile Threshold at Baseline, Week 4 and Week 8

  Baseline, Week 4 and 8

Study Arms (3)

Test Toothpaste 1

EXPERIMENTAL

Participants will be instructed to brush the entire dentition thoroughly using Test toothpaste 1 for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth.

Drug: Test Toothpaste 1

Test Toothpaste 2

EXPERIMENTAL

Participants will be instructed to brush the entire dentition thoroughly using Test toothpaste 2 for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth.

Drug: Test Toothpaste 2

Reference Toothpaste

ACTIVE COMPARATOR

Participants will be instructed to brush the entire dentition thoroughly using Reference toothpaste for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth.

Drug: Reference Toothpaste

Interventions

Test Toothpaste 1 DRUG

Toothpaste containing Potassium nitrate

Test Toothpaste 1

Test Toothpaste 2 DRUG

Toothpaste containing Potassium nitrate

Test Toothpaste 2

Reference Toothpaste DRUG

Regular fluoride toothpaste

Reference Toothpaste

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 signed and dated informed consent before any study procedures are performed.
• Participant is biologically male or female.
• Participant is 18 to 65 years of age, inclusive, at the time of signing the consent form.
• Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions and other study procedures.
• Participant is in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history (example, a medical condition confirmed to be causing xerostomia), or upon oral examination, that would impact their safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
• Participant must have History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported) and must have good general oral health, with a minimum of 20 natural teeth.
• Participant must have minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants

You may not qualify if:

• Participant is an employee of the study site directly involved in the conduct of the study, or an employee of the study site otherwise supervised by the investigator, or a member of their immediate family.
• Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
• Female participant who is pregnant (self-reported) or intending to become pregnant during the study (self-reported) or who is who is breastfeeding (self-reported).
• Participant with known or suspected intolerance or hypersensitivity to any of the study products (Acclimatization Toothpaste or study toothpastes), any of their stated ingredients or closely related compounds (self-reported).
• Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported).
• Participant is participating in, or has participated in, other studies (including non-medicinal studies) involving an investigational product (IP) within 30 days of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study (self-reported).
• Participant has participated in a tooth sensitivity study within 8 weeks of Screening (Visit 1) (self-reported).
• Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used an anti-hypersensitivity oral care product within 8 weeks of Screening (Visit 1) (self-reported).
• Participant is currently using an oral care product primarily intended for tooth whitening benefits or has used such a product within 8 weeks of Screening (Visit 1) (self-reported).
• Participant has had professional tooth de-sensitizing treatment within 8 weeks of Screening (Visit 1) (self-reported).
• Participant is taking daily doses of medications/treatments (self-reported) which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
• Participant is taking daily doses of a medication (self-reported) which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
• Participant requires antibiotic prophylaxis for dental procedures (self-reported).
• Participant has had a tooth whitening procedure (professional or in-home treatment) within 12 months of Screening (Visit 1) (self-reported).
• Participant has had dental prophylaxis within 8 weeks of Screening (Visit 1) (self-reported).

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Silverstone Research Group

Las Vegas, Nevada, 89146, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

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

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: December 15, 2025
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

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 granted, when justified, for up to another 12 months.

Locations

US (1)