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.
1 other identifier
interventional
272
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2017
CompletedFirst Submitted
Initial submission to the registry
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2018
CompletedResults Posted
Study results publicly available
October 5, 2020
CompletedOctober 5, 2020
September 1, 2020
12 months
July 18, 2017
July 20, 2020
September 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Tactile (Yeaple Probe) Stimuli
4-weeks of product use (Day 28)
Visual Analogue Scale
4-weeks of product use (Day 28)
Other Outcomes (3)
Thermo-evaporative (Schiff Air Blast) Stimuli
Day 29, 12 hours after product use has ceased
Tactile (Yeaple Probe) Stimuli
Day 29, 12 hours after product use has ceased
Visual Analogue Scale
Day 29, 12 hours after product use has ceased
Study Arms (2)
CSSP Toothpaste
EXPERIMENTALToothpaste containing Calcium Silicate and Sodium Phosphate
Fluoride Toothpaste
PLACEBO COMPARATORToothpaste containing Sodium monofluorphosphate
Interventions
Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unilever R&Dlead
- University of Bristolcollaborator
Study Sites (1)
School of Oral and Dental Science
Bristol, BS1 2LY, United Kingdom
Related Publications (1)
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.
PMID: 32497553DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Jane Matheson
- Organization
- Unilever
Study Officials
- PRINCIPAL INVESTIGATOR
Nicola X West, Professor
University of Bristol
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2017
First Posted
August 9, 2017
Study Start
June 19, 2017
Primary Completion
June 13, 2018
Study Completion
June 13, 2018
Last Updated
October 5, 2020
Results First Posted
October 5, 2020
Record last verified: 2020-09