Dentine Hypersensitivity
Conditions
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.
Detailed description
This is a single center, non-comparative design study to investigate the effect of long-term management of DH by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene, with associated changes in gingival health. Sufficient participants will be screened to ensure approximately 70 eligible participants get allocated the study toothpaste in order to ensure that approximately 60 participants complete the study.
Interventions
OTHERTest Toothpaste
Marketed toothpaste containing 5 percent (%) weight by weight (w/w) NovaMin / 1426 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
Sponsors
HALEON
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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, 1. No clinically significant or relevant abnormalities of medical history or oral examination which could impact study outcomes. 2. 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: 1. Tooth with signs of erosion, abrasion and/or facial/cervical gingival recession (EAR). 2. 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: 1. 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 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 1. Participation in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit. 2. Participation in a tooth desensitizing treatment study within 8 weeks of the screening visit. 3. 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 1. Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes. 2. Any condition which, in the opinion of the investigator, is causing xerostomia. * General Dentition Exclusions 1. Dental prophylaxis within 4 weeks of screening. 2. Tongue or lip piercing 3. Desensitizing treatment within 8 weeks of screening (professional sensitivity treatments and non-dentifrice sensitivity treatments). 4. Treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planing within 3 months of screening. 5. Teeth bleaching within 8 weeks of screening. 6. Current active caries or periodontitis which, in the opinion of the investigator, could affect study outcomes, or the health of the subject if they participate in the study. 7. Partial dentures, orthodontic appliances or dental implants which, in the opinion of the investigator, could affect study outcomes. 8. Restorations in a poor state of repair which, in the opinion of the investigator, could affect study outcomes. * Specific Dentition Exclusions for Teeth Selected for Sensitivity Assessments 1. Tooth with evidence of current or recent caries or reported treatment of decay in 12 months of screening. 2. Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine. 3. Sensitive tooth not expected, in the opinion of the investigator, to respond to treatment with an over-the-counter toothpaste. * Use of a sensitivity oral care product within 8 weeks of screening. * Any participants who, in the opinion of the investigator, should not participate in the study, use of medication which could interfere in the outcome of the study or require antibiotic prophylaxis for dental procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score | Baseline and up to Week 24 | 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 | Baseline and up to Week 24 | 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. |
| Change From Baseline in Labelled Magnitude Scales (LMS) Score | Baseline and up to Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Turesky Plaque Index (TPI) | Baseline and up to Week 24 | TPI will be used to assess plaque on all gradable teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Three scores will be recorded buccally/labially and three scores lingually/palatally. Disclosed plaque will be scored on a scale ranging from 0-6, where 0= No plaque, 1= Slight flecks of plaque at the cervical margin of the tooth, 2= Thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth, 3= Band of plaque wider than 1 mm but covering less than (\<)1/3 of the area, 4= Plaque covering at least 1/3 but less than 2/3 of the area, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicates improvement in the symptoms. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. |
| Change From Baseline in Modified Gingival Index [MGI] | Baseline and up to Week 24 | The MGI assessment is a non-invasive evaluation which focuses on the visual symptoms of gingivitis. It will be assessed on the facial and lingual surfaces of each scorable tooth using a 5-point scale ranging from 0 to 4, where 0= absence of inflammation 1= mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit. 2= mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit. 3= moderate inflammation; glazing, redness, oedema, and/or hypertrophy of the marginal or papillary gingival unit. 4= severe inflammation; marked redness, oedema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score indicates improvement in the symptoms. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. |
| Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score | Baseline and up to Week 24 | 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. |
Countries
United Kingdom
Outcome results
None listed