A Study to Measure the Efficacy of a Toothpaste on Dentin... | NCT03244618

NCT03244618

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
University of Bristol	OTHER

Description Module

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.

Label	Type	Description	Intervention Names
CSSP Toothpaste	Experimental	Toothpaste containing Calcium Silicate and Sodium Phosphate	Device: CSSP Toothpaste
Fluoride Toothpaste	Placebo Comparator	Toothpaste containing Sodium monofluorphosphate	Device: Fluoride Toothpaste

Name	Type	Description	Arm Group Labels	Other Names
CSSP Toothpaste	Device	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate	CSSP Toothpaste

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

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.

Eligibility Module

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.

Name	Affiliation	Role
Nicola X West, Professor	University of Bristol	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
School of Oral and Dental Science		Bristol		BS1 2LY	United Kingdom

PubMed Identifier	Type	Citation	Retractions
32497553	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	CSSP Toothpaste	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.
FG001	Fluoride Toothpaste	Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	CSSP Toothpaste	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Analysis was based on all available data at week 4 from subjects who were randomised

Posted

Mean

Standard Deviation

score on a scale

4-weeks of product use (Day 28)

ID	Title	Description
OG000	CSSP Toothpaste	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CSSP Toothpaste	Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases