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

NCT02789618 | Completed

• 1 other identifier: ORL-SEN-2267
• Study Type: interventional
• Target: 137
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dentine Sensitivity

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

A01

ACTIVE COMPARATOR

Toothpaste containing calcium silicate and Sodium Monofluorophosphate (1450ppm F) and a gel containing sodium fluoride (1450ppm F)

Other: A01

B99

ACTIVE COMPARATOR

Toothpaste containing Stannous Fluoride and a dentinal bonding agent

Other: B99

M89

PLACEBO COMPARATOR

Toothpaste containing sodium fluoride (1450ppm F)

Other: M89

Interventions

A01 OTHER

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

A01

B99 OTHER

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.

B99

M89 OTHER

Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days.

M89

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unilever R&D: lead
• Pesquisa e Ensino em Saúde, Porto Allegre, Brazil: collaborator

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Prorenin Receptor

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Proton-Translocating ATPases; Adenosine Triphosphatases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; ATP Synthetase Complexes; Phosphotransferases (Phosphate Group Acceptor); Phosphotransferases; Transferases; Proton Pumps; Cation Transport Proteins; Ion Pumps; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface

Study Officials

• Sabrina Gomes

  PENSA, Rua Carvalho Monteiro 234/601, Porto Alegre, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 3, 2016
• Study Start: October 1, 2016
• Primary Completion: December 22, 2016
• Study Completion: December 22, 2016
• Last Updated: June 8, 2018

Record last verified: 2016-05