N/A
N=263
A Study to Measure the Efficacy of a Toothpaste on Dentinal Hypersensitivity
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT03244618 ↗Enrolled (actual)
263
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Thermo-evaporative (Schiff Air Blast) Stimuli — 2.188; 2.246; 1.268; 1.811 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CSSP Toothpaste (Device); Fluoride Toothpaste (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Unilever R&D
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Thermo-evaporative (Schiff Air Blast) Stimuli |
2.188; 2.246; 1.044; 1.713 | <0.001 sig |
| SECONDARY Tactile (Yeaple Probe) Stimuli |
17.5; 16.6; 41.5; 29.7 | <0.001 sig |
| SECONDARY Visual Analogue Scale |
48.1; 49.9; 27.2; 38.1 | <0.001 sig |
Summary
Double blind parallel study to measure the efficacy of a toothpaste containing calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste containing fluoride
Eligibility Criteria
Inclusion Criteria
- Male and female subjects aged 18 years and older.
- Willing and physically able to carry out all study procedures.
- Willing and able to give written informed consent and complete a medical history form.
- Have at least one hypersensitive tooth in two quadrants, which are anterior to the molars and demonstrate cervical dentine, which have an air-blast hypersensitivity score of 2 or 3 on the Schiff sensitivity scale at Screening and Baseline and a tactile hypersensitivity score of 10-20 grams of force at baseline.
- Willing to comply with the oral hygiene and food and drink restrictions.
Exclusion Criteria
- Subjects who have used anti sensitivity products in the 4 weeks prior to screening
- Subjects with an active oral ulcer (Aphthous ulcer), or have similar experience within past 1 month.
- Subjects who use a powered toothbrush at least 4 times a week to brush their teeth
- Subjects whose indicator teeth have abnormal oral pathology, for example:
- Extensive restorations.
- Observable caries.
- Observable cracked enamel.
- Leaking fillings or other restorations.
- Cracked Tooth Syndrome
- Suspected pulp pathology/abscess/pulpitis.
- Atypical facial pain
- Any tooth surface adjacent to those surfaces under investigation, which in the opinion of the investigator have any other condition(s) that provide confusing symptoms to those of cervical dentine hypersensitivity.
- Currently undergoing dental treatment, including orthodontic treatment.
- Subjects who have had vital bleaching within 4 weeks of the screening visit
- Known allergies to any toothpaste ingredients, including the flavour components.
- Obvious physical disability reducing tooth brushing ability.
- Receiving concomitant medication/therapy that might affect dentine hypersensitivity, e.g. regular use of analgesics, anti-histamines, non-steroidal anti-inflammatory drug and selective serotonin reuptake inhibitor medication
- Severe gingivitis, periodontitis and/or marked tooth mobility.
- Gingival surgery in the previous six months.
- In the opinion of the investigator unable to comply fully with the trial requirements.
- Participation in other dental clinical trials in the previous 28 days
- Subjects who have participated in an dentinal hypersensitivity study within the previous 1 month.
- Diabetic (both Type 1 and Type 2)
- Medical condition(s) and/or regular use of any medication, which either could affect the scientific validity of the study or if the subject was to participate in the study could, affect their wellbeing.
- Smokers or e-cigarette use or those who have smoked/vaped in the previous 12 months
- Brushing 53g of toothpaste in a two week period during the test phase
- The subject is an employee of Unilever or the site conducting the study.
Data sourced from ClinicalTrials.gov (NCT03244618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.