Study to Investigate the Effect of Changes in Dentinal Hypersensitivity on Oral Health Parameters

NCT07768969 | Completed

• 1 other identifier: RH01897
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study will investigate the effect of long-term management of Dentine Hypersensitivity (DH) by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene (as measured by supra-gingival plaque accumulation), with associated changes in gingival health.

Conditions

Dentine Hypersensitivity

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Schiff Sensitivity Score

  Evaporative (air) sensitivity will be assessed by the participant's response to an evaporative (air) stimulus administered by the clinical examiner. Participant response will be evaluated immediately following application of the stimulus using the Schiff sensitivity scale (0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of stimulus). A decrease in Schiff sensitivity score indicates improvement. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.

  Baseline and up to Week 24

• Change From Baseline in Tactile Threshold

  Tactile sensitivity will be assessed by the participant's response to a tactile stimulus administered by the clinical examiner using a constant pressure probe (Yeaple probe). After each application of the stimulus, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses will be recorded as the tactile threshold in gram. An increase in tactile threshold (gram) indicates improvement. Change from Baseline will be calculated by subtracting Baseline value from the value at the indicated timepoints.

  Baseline and up to Week 24

• Change From Baseline in Labelled Magnitude Scales (LMS) Score

  The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and rate the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 millimeter (mm) LMS. Participants will mark each scale to indicate the best description of their sensitivity and the marked-off line segment will be measured in 'mm'. Lower scores indicate an improvement in sensitivity. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.

  Baseline and up to Week 24

Secondary Outcomes (3)

• Change From Baseline in Turesky Plaque Index (TPI)

  Baseline and up to Week 24

• Change From Baseline in Modified Gingival Index [MGI]

  Baseline and up to Week 24

• Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score

  Baseline and up to Week 24

Study Arms (1)

Test Toothpaste

EXPERIMENTAL

Participants will brush with the test toothpaste using a manual toothbrush for 1 timed minute twice daily (morning and evening) for 24 weeks.

Other: Test Toothpaste

Interventions

Test Toothpaste OTHER

Marketed toothpaste containing 5 percent (%) weight by weight (w/w) NovaMin / 1426 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)

Test Toothpaste

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Understands and is willing, able and likely to comply with all study procedures and restrictions.
• Good general and mental health with, in the opinion of the investigator,
• No clinically significant or relevant abnormalities of medical history or oral examination which could impact study outcomes.
• The absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
• At screening, self-reported history of DH lasting more than 6 months but not more than 10 years.
• At screening, minimum of two accessible teeth (incisors, canines or pre-molars) that meet all of the following criteria:
• Tooth with signs of erosion, abrasion and/or facial/cervical gingival recession (EAR).
• Tooth with signs of sensitivity measured by qualifying evaporative (air) assessment.
• At Baseline, minimum of two accessible teeth (incisors, canines or pre-molars), that meet the following criteria:
• Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple less than or equal to \[\<=\] 20 gram) and evaporative (air) assessment (Schiff Sensitivity Score greater than or equal to \[\>=\] 2)

You may not qualify if:

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
• Women who are breast-feeding.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Clinical Study/Experimental Medication
• Participation in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit.
• Participation in a tooth desensitizing treatment study within 8 weeks of the screening visit.
• Previous participation in this study.
• Recent history (within the last year) of alcohol or other substance abuse.
• An employee of the sponsor or the study site or members of their immediate family.
• Disease
• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
• Any condition which, in the opinion of the investigator, is causing xerostomia.
• Dental prophylaxis within 4 weeks of screening.
• Tongue or lip piercing
• Desensitizing treatment within 8 weeks of screening (professional sensitivity treatments and non-dentifrice sensitivity treatments).

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Intertek CRS Ltd

Ellesmere Port, Cheshire, CH65 4BW, United Kingdom

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: August 27, 2013
• Primary Completion: March 4, 2014
• Study Completion: March 4, 2014
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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

GB (1)