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

October 13, 2023 updated by: HALEON

A Randomized, Controlled, Single-Blind Clinical Study to Investigate the Tooth Stain Removal Efficacy of Two Experimental Potassium Nitrate Dentifrices in Subjects With Extrinsic Dental Stain Compared to a Standard Dentifrice Control When Used Twice Daily for 8 Weeks

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a single-center, 8-week, randomized, controlled, single-blind, three treatment-arm, parallel design, stratified clinical study in healthy volunteers with a propensity to form dental stain. It has been designed to investigate changes in tooth stain and color, following twice-daily use of two experimental dentifrices, after four and eight weeks twice daily use; a regular fluoride dentifrice will be included as reference dentifrice. Sufficient participants will be screened to randomize approximately 300 participants to study treatment to ensure approximately 270 participants complete the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Melbourne, Florida, United States, 32940
        • All Sum Research Center (c/o Family & Cosmetic Dentistry)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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:

    1. At least 16 natural (vital) teeth including 11 of the 12 anterior teeth.
    2. 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.
    3. 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.
    4. 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.
    5. Baseline Total MLSI (Area x Intensity) greater than or equal to (>=)15 for the facial surfaces of the 12 anterior teeth.
    6. Baseline mean tooth shade (VITA Bleachedguide 3D-MASTER) >=11 on the facial surfaces of the 4 maxillary incisors.

Exclusion Criteria:

  • 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:

    1. currently daily use of mouthwashes containing ingredients known to cause tooth stain (for example, chlorhexidine or cetylpyridinium chloride),
    2. past or current use of minocycline,
    3. use of tetracycline or doxycycline within 30 days of screening and/or during the study,
    4. 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.

  • Specific exclusions for assessment teeth:

    1. Non-vital tooth.
    2. Tooth with evidence of current or recent carious lesions.
    3. Tooth used as an abutment for fixed or partial dentures.
    4. Tooth adjacent to fixed retainers and fixed or removable orthodontic appliances.
    5. Tooth with surface irregularities, cracked enamel, discoloration due to trauma or orthodontic treatment, tetracycline stain, restorations or hyper-/hypoplastic areas, which, in the opinion of the clinical examiner, grading of extrinsic dental stain and tooth shade.
    6. Tooth with a crown or veneer.
    7. Tooth with exposed dentine which, in the opinion of the investigator, could impact grading of extrinsic dental stain and tooth shade.

  • General oral exclusions:

    1. Generalized severe gingivitis or advanced periodontal disease; treatment of periodontal disease (including surgery) within 12 months of screening; scaling or root planning within 3 months of screening.
    2. Any oral condition requiring immediate care.
    3. Having received a dental prophylaxis within 8 weeks of screening.
  • Participant who, in the opinion of the investigator, should not participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Dentifrice 1
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
5 percent (%) potassium nitrate (KNO3) dentifrice with 1% alumina and 5% sodium tripolyphosphate (STP).
Experimental: Experimental Dentifrice 2
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
5% KNO3 dentifrice with 1% alumina, 5% STP and 2% high cleaning silica.
Active Comparator: Reference Dentifrice
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
Regular Fluoride Dentifrice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Total Modified Lobene Stain Index (MLSI) Score at Week 8
Time Frame: Baseline and 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Total MLSI Score at Week 4
Time Frame: Baseline and Week 4
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 4 value.
Baseline and Week 4
Change From Baseline in Mean Total MLSI Score at Weeks 4 and 8
Time Frame: Baseline, Week 4 and 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 value at indicated timepoints.
Baseline, Week 4 and Week 8
Change From Baseline in Mean VITA Shade Score (Examiner Assessed) at Weeks 4 and 8
Time Frame: Baseline, Week 4 and Week 8
Tooth shade (color) of the facial surfaces of the four central and lateral maxillary incisors was assessed by a trained clinical examiner using the VITA Bleached guide 3D-MASTER. It used a value-ranked ordered scale from 1 (the lightest) to 29 (the darkest). The shade level of each tooth surface was scored visually by the clinical examiner with reference to the Bleached guide, where lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.
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
Time Frame: Baseline, Week 4 and Week 8
Extrinsic dental stain area and its intensity were assessed at the specific tooth sites (Gingival site: Crescent-shaped band, adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. Body Site: The remainder of the tooth surface). MLSI score= Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain was scored separately for each tooth on the scale 0 to 3, where 0= area with no stain, 1= Stain covering up to one third area and light intensity stain, 2= Stain covering up to two thirds area and moderate intensity stain, 3= Stain covering more than two thirds 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 value at indicated timepoints.
Baseline, Week 4 and Week 8
Change From Baseline in Mean MLSI (Area) and MLSI (Intensity) at Weeks 4 and 8
Time Frame: Baseline, Week 4 and 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. 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. Thus, MLSI score for both Area and Intensity ranged from 0 to 3, where lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.
Baseline, Week 4 and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HALEON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 300024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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