Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth

NCT ID: NCT05243745

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-10-03

Brief Summary

This proof of principle (PoP) study will evaluate the ability of an experimental combination toothpaste formulation to protect sensitive teeth from dentine hypersensitivity.

Detailed Description

This will be a PoP, single centre, 8-week, randomised, controlled, examiner blind, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth) clinical study in healthy participants with sensitive teeth.

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Test Product

Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product is a combination toothpaste of 3% methyl vinyl ether/maleic anhydride co-polymer (PVM/MA) + 5% Potassium Nitrate (KNO3). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); Participants will be permitted to rinse with water post-brushing.

Group Type: EXPERIMENTAL

3% PVM/MA + 5% KNO3 Combination

Intervention Type: OTHER

Toothpaste containing 3% PVM/MA + 5% KNO3 as combination will be used as test product.

Comparator 1

Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 toothpaste is containing 3% PVM/MA. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.

Group Type: ACTIVE_COMPARATOR

3% PVM/MA only

Intervention Type: OTHER

Toothpaste containing 3% PVM/MA only will be used as comparator 1 product.

Comparator 2

Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 toothpaste is containing 5% KNO3. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.

Group Type: ACTIVE_COMPARATOR

5% KNO3 Only

Intervention Type: OTHER

Toothpastes containing 5% KNO3 only will be used as comparator 2 product.

Negative Control

Participants will dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control is regular fluoride toothpaste. Participants will brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening); participants will be permitted to rinse with water post-brushing.

Group Type: OTHER

Regular Fluoride

Intervention Type: OTHER

Toothpaste containing regular fluoride will be used as negative control.

Interventions

3% PVM/MA + 5% KNO3 Combination

Toothpaste containing 3% PVM/MA + 5% KNO3 as combination will be used as test product.

Intervention Type: OTHER

3% PVM/MA only

Toothpaste containing 3% PVM/MA only will be used as comparator 1 product.

Intervention Type: OTHER

5% KNO3 Only

Toothpastes containing 5% KNO3 only will be used as comparator 2 product.

Intervention Type: OTHER

Regular Fluoride

Toothpaste containing regular fluoride will be used as negative control.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Provision of a signed and dated informed consent indicating the participant has been informed of all pertinent aspects of the study before any study procedures are performed.
• Participant who is willing and able to comply with scheduled visits, product usage requirements and other study procedures.
• Participant 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 medical history, or upon oral examination, that would impact the participant's safety or 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.
• Female participant of child-bearing potential and at risk for pregnancy who agrees to use a highly effective method of contraception throughout the study and for at least 5 days after the last use of assigned study product.
• AT VISIT 1 (Screening):

Participant must have

1. a self-reported history of tooth sensitivity lasting more than six months but not more than 10 years.

2. a minimum of 20 natural teeth.

3. a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH; each tooth must meet the following criteria:

• exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR).
• MGI score = 0 adjacent to the test area (exposed dentine) only (Lobene et al.,1986)
• clinical mobility = 0 (Laster et al., 1975)
• Dentin Hypersensitivity (DH) as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to <= 20 gram (g); Schiff sensitivity score greater than or equal to >= 2).
• AT VISIT 2 (Baseline):

Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, pre molars) with DH, as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to <= 20 g; Schiff sensitivity score >= 2) at the Screening and Baseline visits.

Note: All teeth which meet the eligibility criteria at Screening (Visit 1) should be assessed by tactile and evaporative (air) stimuli at Baseline (Visit 2).

Exclusion Criteria

• Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a GlaxoSmithKline Consumer Healthcare (GSK CH) employee 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.
• 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.
• Female participant who is pregnant (as evidenced by a positive urine pregnancy test (UPT) at Screening) or intending to become pregnant during the study.
• Female 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 unable to comply with the Lifestyle Considerations.
• Participant with a recent history (within the last year) of alcohol or other substance abuse.
• Participant who has participated in another tooth sensitivity study within 8 weeks of Screening.
• Participant who has used an oral care product indicated for the relief of DH or care of sensitive teeth within 8 weeks of Screening (participants will be required to verbally confirm the name of their current oral care products to enable site staff to verify the absence of known sensitivity ingredients).
• Participant who has had dental prophylaxis within 4 weeks of Screening.
• Participant who has had a teeth bleaching procedure within 8 weeks of Screening.
• Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening.
• Participant who has had scaling or root planning within 3 months of Screening.
• Participant with gross periodontal disease.
• Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.
• Participant with a tongue or lip piercing.
• Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator, would impact study outcomes.
• Participant with multiple dental implants which, in the opinion of the investigator, would impact study outcomes.
• Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.
• SPECIFIC DENTITION EXCLUSIONS FOR 'TEST TEETH':

1. Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening.

2. Tooth with exposed dentine but with deep, defective or facial restorations.

3. Tooth with full crown or veneer.

4. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator, would impact study outcomes.

5. Sensitive tooth with contributing etiologies other than erosion, abrasion or recession to exposed dentine.

6. Sensitive tooth not expected to benefit from use of a sensitivity toothpaste in the opinion of the investigator

• Participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, antidepressants, mood-altering and anti-inflammatory drugs).
• AT VISIT 1 (Screening):

Participant who has taken antibiotics in the 2 weeks prior to the Screening visit.

• AT VISIT 2 (Baseline): Participant who has taken antibiotics in the 2 weeks prior to the Baseline visit, during the acclimatisation period.

• Participant who is taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
• Participant who requires antibiotic prophylaxis for dental procedures.
• Participant who has previously been enrolled in this study.
• Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HALEON

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bristol Dental School, University of Bristol

Bristol, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

218220

Identifier Type: -

Identifier Source: org_study_id