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N/A N=263 Randomized Triple-blind Treatment

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

Dentin Sensitivity

Enrolled (actual)
263
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Thermo-evaporative (Schiff Air Blast) Stimuli — 2.188; 2.246; 1.268; 1.811 score on a scale — p=<0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CSSP Toothpaste (Device); Fluoride Toothpaste (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Unilever R&D
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Thermo-evaporative (Schiff Air Blast) Stimuli
2.188; 2.246; 1.044; 1.713 <0.001 sig
SECONDARY
Tactile (Yeaple Probe) Stimuli
17.5; 16.6; 41.5; 29.7 <0.001 sig
SECONDARY
Visual Analogue Scale
48.1; 49.9; 27.2; 38.1 <0.001 sig

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

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 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03244618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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