Dentine Hypersensitivity
Conditions
Brief summary
The aim of this study is to evaluate the clinical efficacy of two experimental mouthwash formulations, against a placebo mouthwash (without experimental ingredients). One experimental formulation to be used either once daily or twice daily, and the second experimental formulation and placebo, to be used twice daily for the treatment of dentinal hypersensitivity.
Detailed description
This study will be an 8 week, randomized, examiner blind four treatment arm, parallel group design, stratified (by Baseline Schiff Sensitivity Score), in participants that meet all the criteria at the Screening and Baseline visits. Approximately 280 participants will be screened to randomize approximately 115 participants (to achieve approximately 30 participants to complete in each treatment group for twice daily usage and 15 to complete for the once daily usage group).
Interventions
OTHER3% KNO3 Mouthwash
3.0% weight by weight (w/w) KNO3 with 217 parts per million (ppm) sodium fluoride.
OTHER2% HPC Mouthwash
2.0% w/w HPC mouthwash with 217ppm sodium fluoride.
OTHER0% KNO3 Mouthwash
0% w/w KNO3 with 217ppm sodium fluoride.
Sponsors
HALEON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Participant who 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. * Participant understands and is willing, able and likely to comply with all study procedures and restrictions. * A participant with a minimum of 20 natural teeth and in good general health who suffer from tooth sensitivity. * At screening, participants with a minimum of four accessible nonadjacent teeth (incisors, canines, or pre-molars) with signs of facial/cervical gingival recession and/or signs of erosion or abrasion. * At screening, self-reported history of Dentinal Hypersensitivity lasting more than 6 months but not more than 10 years. * At Baseline: Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), that meet all of 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)
Exclusion criteria
* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. * Women who are breastfeeding. * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * Participation in another clinical study or receipt of an investigational drug within 30 days of the Screening visit. * Participation in a desensitising 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. * Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes. * Dental prophylaxis within 4 weeks of Screening. * Tongue or lip piercing or presence of dental implants. * Desensitizing treatment within 8 weeks of Screening. * Teeth bleaching within 8 weeks of Screening. * Any participant who, in the judgment of the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score at Weeks 4, 6 and 8 | Baseline, Weeks 4, 6 and 8 | 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. |
| Change From Baseline in Tactile Threshold at Weeks 4, 6 and 8 | Baseline, Weeks 4, 6 and 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Individual Questions Score from Dentine Hypersensitivity Experience Questionnaire (DHEQ) at Weeks 4 and 8 | Baseline, Weeks 4 and 8 | The DHEQ is used to measure how Dentin Hypersensitivity (DH) affects participants quality of life. Participant will respond to three individual questions from section 1 of DHEQ- 1. How intense are the sensations? 2. How bothered are you by any sensations? 3. How well can you tolerate sensations? The response to the questions will be scored using a 10-point scale ranging from 1 to 10, where lower score indicates a less severity of symptoms. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints. |
| Change From Baseline in DHEQ Total Score at Week 4 and 8 | Baseline, Weeks 4 and 8 | The DHEQ is used to measure how DH affects participants quality of life. Section 2 has 34 questions in grouped into 5 domains (Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity). Participants will score each question using a 7-point scale ranging from 1 to 7, where 1= strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score will be derived from the sum of scores across all domains and it ranges from 34 to 238. A lower score indicates a better quality of life regarding DH. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. |
| Change From Baseline in Global Oral Health Score at Week 4 and 8 | Baseline, Weeks 4 and 8 | Global Oral Health is evaluated using a single question of DHEQ. Participants will rate the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicates better oral health. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. |
| Change From Baseline in Effect on Life Overall Score at Week 4 and 8 | Baseline, Weeks 4 and 8 | Effect on life will be evaluated using 4 questions of DHEQ about how much the sensation in teeth affects participant's life overall. Participants will score each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranges from 0 to 16, where lower score indicates less effect of sensations on participant's life overall. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. |
Countries
Germany
Outcome results
None listed