A Pilot Study to Substantiate the Use of the Jay Sensitivity Sensor Probe

A Pilot Study to Substantiate the Use of the Jay Sensitivity Sensor Probe by Correlating the Results With the Those of Yeaple Probe, Schiff Air Blast, Visual Analogue Scale (VAS) and Oral Health Impact Profile Questionnaire (OHIP)

Subjects with at least two teeth with dentinal hypersensitivity and who meet the study criteria will be enrolled onto this double blind, randomised, parallel, controlled clinical trial. After enrolment, suitable subjects will use a fluoride toothpaste for 4 weeks (wash out period). Baseline dentine hypersensitivity assessments will be conducted using tactile stimuli, air blast, and VAS methods. Tactile methods of assessment will include use of the Yeaple Probe and the Jay Sensitivity Sensor probe. Air blast assessments will be conducted using the Schiff cold air sensitivity scale. The Oral Health Impact Profile (OHIP) questionnaire will be completed at four defined time points during the study. The baseline assessments will be conducted on the two teeth identified during the screening visit.

On completion of the baseline assessments, subjects will be randomly assigned to product. Dentinal hypersensitivity assessments will be repeated after 18, 28 and 56 days of product use.

Study Overview

• Status: Completed
• Conditions: Dentine Sensitivity
• Intervention / Treatment: Other: A01; Other: B99; Other: M89

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Willing and physically able to carry out all study procedures.
• Willing to give written informed consent and complete a medical history form.
• Have one hypersensitive tooth in two quadrants with exposed roots, which are anterior to the molars and demonstrate cervical erosion/abrasion or gingival recession, which have an air-blast hypersensitivity score of 2 or 3 on the Schiff sensitivity scale at Screening and a tactile hypersensitivity score of 10-60 grams of force using the Yeaple probe at baseline.
• Willing to comply with the oral hygiene and food and drink restrictions.

Exclusion Criteria:

Individuals with the following conditions will not be eligible for participation in the study:

• Subjects who have used anti sensitivity products in the 4 weeks prior to screening
• Subjects likely to require the use of professional dentinal desensitising therapy during the study.
• Subjects with an active oral ulcer (aphthous ulcer), or have similar experience within past 1 month.

• Subjects whose indicator teeth have abnormal oral pathology, for example:

  • Extensive restoration.
  • 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 had vital bleaching
• Investigational teeth are or are likely to become denture abutments during the course of the study.
• Known allergies to toothpaste and serum 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, SSRI medication
• Severe gingivitis, periodontitis and/or marked tooth mobility.
• Gingival surgery in the previous six months.
• Subjects with any serious concomitant diseases or medical or psychological conditions.
• In the opinion of the investigator unable to comply fully with the trial requirements.
• Participation in other dental clinical trials.
• Pregnant or breastfeeding (Self-Reported)
• Subjects who have participated in an oral care study within the previous 3 months.
• Diabetic (both Type 1 and Type 2)
• Previous history of rheumatic fever or heart valve pathology or require antibiotics for prophylaxis against bacterial endocarditis.
• 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.
• Use of anticonvulsants; antihistamines; anti-depressants; sedatives; tranquilisers; anti-inflammatory drugs or daily analgesics.
• Full or removable partial dentures.
• The subject is an employee of Unilever or the site conducting the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A01; Toothpaste containing calcium silicate and Sodium Monofluorophosphate (1450ppm F) and a gel containing sodium fluoride (1450ppm F)	Other: A01; Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The gel will be applied in the evening of three consecutive days during the study time period
Active Comparator: B99; Toothpaste containing Stannous Fluoride and a dentinal bonding agent	Other: B99; Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The bonding agent will be professional applied immediately prior to the clinical assessments.
Placebo Comparator: M89; Toothpaste containing sodium fluoride (1450ppm F)	Other: M89; Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentin hypersensitivity as measured using the Jay Probe	Reduction in pain caused by dentin hypersensitivity will be measured using the Jay Probe (Tactile Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement	Baseline, 18 days, 29 days and 57 days
Dentin hypersensitivity as measured using the Yeaple Probe	Reduction in pain caused by dentin hypersensitivity will be measured using the Yeaple Probe (Tactile Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement	Baseline, 18 days, 29 days and 57 days
Dentin hypersensitivity measured using the Schiff assessment	Reduction in pain caused by dentin hypersensitivity will be measured using the Schiff assessment (Air Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement	Baseline, 18 days, 29 days and 57 days
An assessment of dentin hypersensitivity using the OHIP quality of life questionnaire	Specific quality of life attributes and the impact of dentin hypersensitivity on subject's daily life will be measured (subjective measure)	Baseline, 18 days, 29 days and 57 days
Dentin hypersensitivity measured using the visual analogue scale (VAS)	Reduction in pain caused by dentin hypersensitivity will be measured using the Visual Analogue Scale (VAS) on day 18, day 29 and day 57 and compared to the baseline measurement	Baseline, 18 days, 29 days and 57 days

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Pesquisa e Ensino em Saúde, Porto Allegre, Brazil
• Investigators: Principal Investigator: Sabrina Gomes, PENSA, Rua Carvalho Monteiro 234/601, Porto Alegre, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 22, 2016
• Study Completion (Actual): December 22, 2016

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (Estimate): June 3, 2016

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: ORL-SEN-2267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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