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

NCT05243745 | Completed Results

• 1 other identifier: 218220
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (15)

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)

  Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface,approximately 1-2 millimeter(mm) coronal to gingival margin from a distance of approximately 1 centimeter(cm). Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

  Baseline (Day 0)

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3

  Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

  Day 3

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14

  Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

  Day 14

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28

  Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

  Day 28

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56

  Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

  Day 56

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)

  Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (grams \[g\]). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as greater than (\>) 20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Baseline (Day 0)

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3

  Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as \>20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 3

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14

  Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as \>20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 14

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28

  Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as \>20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 28

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56

  Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as \>20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 56

• Mean Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) at Baseline (Day 0)

  Sensitive teeth were defined as teeth with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

  Baseline (Day 0)

• Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3

  Sensitive teeth were defined as teeth with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

  Day 3

• Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14

  Sensitive teeth were defined as teeth with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

  Day 14

• Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28

  Sensitive teeth were defined as teeth with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

  Day 28

• Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56

  Sensitive teeth were defined as teeth with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

  Day 56

Secondary Outcomes (11)

• Change From Baseline in Schiff Sensitivity Score at Days 3, 14, 28 and 56

  Baseline (Day 0), Days 3, 14, 28 and 56

• Change From Baseline in Tactile Threshold at Days 3, 14, 28 and 56

  Baseline (Day 0), Days 3, 14, 28 and 56

• Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56

  Baseline (Day 0), Days 3, 14, 28 and 56

• Change From Baseline in DHEQ Total Score (Section 2 Questions 1-15) at Days 3, 14, 28 and 56

  Baseline (Day 0), Days 3, 14, 28 and 56

• Change From Baseline in DHEQ Restrictions Domain Score (Section 2 Questions 1 to 3) at Days 3, 14, 28 and 56

  Baseline (Day 0), Days 3, 14, 28, 56

Study Arms (4)

Test Product

EXPERIMENTAL

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.

Other: 3% PVM/MA + 5% KNO3 Combination

Comparator 1

ACTIVE COMPARATOR

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.

Other: 3% PVM/MA only

Comparator 2

ACTIVE COMPARATOR

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.

Other: 5% KNO3 Only

Negative Control

OTHER

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.

Other: Regular Fluoride

Interventions

3% PVM/MA + 5% KNO3 Combination OTHER

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

Test Product

3% PVM/MA only OTHER

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

Comparator 1

5% KNO3 Only OTHER

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

Comparator 2

Regular Fluoride OTHER

Toothpaste containing regular fluoride will be used as negative control.

Negative Control

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 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
• a self-reported history of tooth sensitivity lasting more than six months but not more than 10 years.
• a minimum of 20 natural teeth.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Bristol Dental School, University of Bristol

Bristol, BS1 2LY, United Kingdom

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+441932 95 95 00

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: February 28, 2022
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: September 20, 2024
• Results First Posted: September 20, 2024

Record last verified: 2024-05

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, a 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

GB (1)