A Study to Measure the Efficacy of a Toothpaste on Dentinal Hypersensitivity

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.

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

Study Overview

• Status: Completed
• Conditions: Dentin Sensitivity
• Intervention / Treatment: Device: CSSP Toothpaste; Device: Fluoride Toothpaste

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.

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS1 2LY
    • School of Oral and Dental Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CSSP Toothpaste; Toothpaste containing Calcium Silicate and Sodium Phosphate	Device: CSSP Toothpaste; Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate
Placebo Comparator: Fluoride Toothpaste; Toothpaste containing Sodium monofluorphosphate	Device: Fluoride Toothpaste; Toothpaste containing sodium monofluorphosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermo-evaporative (Schiff Air Blast) Stimuli	Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome.	4-weeks of product use (Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tactile (Yeaple Probe) Stimuli	The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.	4-weeks of product use (Day 28)
Visual Analogue Scale	Visual Analogue Scale values were recorded to give the outcome variable per subject at the same time asSchiff assessment. The VAS values were assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).	4-weeks of product use (Day 28)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermo-evaporative (Schiff Air Blast) Stimuli	Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity will be recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.	Day 29, 12 hours after product use has ceased
Tactile (Yeaple Probe) Stimuli	The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.	Day 29, 12 hours after product use has ceased
Visual Analogue Scale	Visual Analogue Scale values of the same teeth will be also be recorded to give the outcome variable per subject at the same time of Schiff assessment. The VAS values will be assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).	Day 29, 12 hours after product use has ceased

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: University of Bristol
• Investigators: Principal Investigator: Nicola X West, Professor, University of Bristol

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): June 13, 2018
• Study Completion (Actual): June 13, 2018

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: ORL-SEN-2530

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No