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

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CSSP Toothpaste
Fluoride Toothpaste
Sponsored by
Unilever R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Oral and Dental Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CSSP Toothpaste

Fluoride Toothpaste

Arm Description

Toothpaste containing Calcium Silicate and Sodium Phosphate

Toothpaste containing Sodium monofluorphosphate

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
July 18, 2017
Last Updated
September 9, 2020
Sponsor
Unilever R&D
Collaborators
University of Bristol
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1. Study Identification

Unique Protocol Identification Number
NCT03244618
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
June 13, 2018 (Actual)
Study Completion Date
June 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
Collaborators
University of Bristol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CSSP Toothpaste
Arm Type
Experimental
Arm Description
Toothpaste containing Calcium Silicate and Sodium Phosphate
Arm Title
Fluoride Toothpaste
Arm Type
Placebo Comparator
Arm Description
Toothpaste containing Sodium monofluorphosphate
Intervention Type
Device
Intervention Name(s)
CSSP Toothpaste
Intervention Description
Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate
Intervention Type
Device
Intervention Name(s)
Fluoride Toothpaste
Intervention Description
Toothpaste containing sodium monofluorphosphate
Primary Outcome Measure Information:
Title
Thermo-evaporative (Schiff Air Blast) Stimuli
Description
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.
Time Frame
4-weeks of product use (Day 28)
Secondary Outcome Measure Information:
Title
Tactile (Yeaple Probe) Stimuli
Description
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.
Time Frame
4-weeks of product use (Day 28)
Title
Visual Analogue Scale
Description
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).
Time Frame
4-weeks of product use (Day 28)
Other Pre-specified Outcome Measures:
Title
Thermo-evaporative (Schiff Air Blast) Stimuli
Description
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.
Time Frame
Day 29, 12 hours after product use has ceased
Title
Tactile (Yeaple Probe) Stimuli
Description
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.
Time Frame
Day 29, 12 hours after product use has ceased
Title
Visual Analogue Scale
Description
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).
Time Frame
Day 29, 12 hours after product use has ceased

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola X West, Professor
Organizational Affiliation
University of Bristol
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Oral and Dental Science
City
Bristol
ZIP/Postal Code
BS1 2LY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32497553
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.
Results Reference
derived

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

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