Clinical trial NCT03244618: A Study to Measure the Efficacy of a Toothpaste on Dentinal Hypersensitivity
Official title: A Medical Device Study to Measure the Efficacy of a Toothpaste Containing Calcium-silicate/Phosphate on Dentinal Hypersensitivity Compared to a Control Toothpaste Containing Fluoride.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: University of Bristol
First posted: 2017-08-09
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: This is a double blind parallel design, with respect to the clinical assessor and subject, study. A minimum of 280 (140 per group), male and female subjects will be recruited to ensure that a minimum of 200 subjects (100 per group) complete the study. Subjects will attend the test site on six (6) occasions.

Subjects will be screened according to the inclusion and exclusion criteria. Suitable subjects will be given a standard fluoride toothpaste and a toothbrush to use for the following four to six weeks (Run-in Phase).

On completion of the run in phase, the subjects will have a baseline sensitivity and soft tissue assessments conducted and randomised to product (visit 3).

Subjects will be randomly assigned to the test groups.

Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. Instructions for use (IFUs) will be given to the subjects along with a toothbrushing diary and an appointment to return to the test site 2 weeks (+/-1 day) later.

At the Day 14 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated.

Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. A fresh toothbrushing diary will be given to the subject along with an appointment to return to the test site 2 weeks later (Week 4 assessment). Subjects will be instructed to brush their teeth as per the IFU for the following 2 weeks.

At the Day 28 visit subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. Prior to leaving the study site, the subjects will be asked to brush their teeth as per the IFU. Subjects will be requested to brush their teeth at a specific time and return to the study site the following day.

At the Day 29 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. On completion of the assessments, subjects will receive their remuneration for the participating in the study.

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 \< 10 times a week during the Run-In period (self-reported)
* Using \<17g or \> 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.

Primary outcomes:
measure: Thermo-evaporative (Schiff Air Blast) Stimuli
timeFrame: 4-weeks of product use (Day 28)
Secondary outcomes:
measure: Tactile (Yeaple Probe) Stimuli
timeFrame: 4-weeks of product use (Day 28)
measure: Visual Analogue Scale
timeFrame: 4-weeks of product use (Day 28)
Other outcomes:
measure: Thermo-evaporative (Schiff Air Blast) Stimuli
timeFrame: Day 29, 12 hours after product use has ceased
measure: Tactile (Yeaple Probe) Stimuli
timeFrame: Day 29, 12 hours after product use has ceased
measure: Visual Analogue Scale
timeFrame: Day 29, 12 hours after product use has ceased
Locations:
city: Bristol
country: United Kingdom
facility: School of Oral and Dental Science
Study officials:
affiliation: University of Bristol
name: Nicola X West, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seong J, Newcombe RG, Matheson JR, Weddell L, Edwards M, West NX. A randomised controlled trial investigating efficacy of a novel toothpaste containing calcium silicate and sodium phosphate in dentine hypersensitivity pain reduction compared to a fluoride control toothpaste. J Dent. 2020 Jul;98:103320. doi: 10.1016/j.jdent.2020.103320. Epub 2020 Jun 1.