Oral and Dental Tolerance and Efficacy on Dentinal Hypersensitivity of a Dental Gel, on Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dentinal Hypersensitivity
- Sponsor
- Pierre Fabre Dermo Cosmetique
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Global tolerance according to a 5-point grading scale taking into account physical signs observed and graded by the dentist and functionnal signs observed and graded by the patient
- Last Updated
- 10 years ago
Overview
Brief Summary
The aim of this clinical trial is to evaluate the tolerance and efficacy of a dental gel in patients with dentinal hypersensitivity.
Detailed Description
The aim of this clinical trial is to evaluate the tolerance and efficacy of dental gel V063B-DP3003 in patients with dentinal hypersensitivity, under normal conditions of use, under dentist control. The primary objective of this study is to evaluate the global oral and dental tolerance of the studied product after 28 days of use. Some efficacy objectives have been added to observe the efficacy of the dental gel. The dentinal hypersensitivity will be evaluated by the investigator with a thermal stimulus on two sensitive teeth selected by the investigator.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female
- •Aged between18 and 70 years included
- •Having signed his/her written informed consent,
- •If it is a woman of childbearing potential :
- •Must have been using an effective method of contraception Negative Urine pregnancy test at inclusion,
- •Subject who can be reached in case of emergency,
- •Subject willing to be compliant to the protocol,
- •Subject able to fill out the daily log and the questionnaire.
- •Subject with at least 20 natural teeth (especially on the studied teeth),
- •Subject with an healthy gum status according to the investigator,
Exclusion Criteria
- •Subject participating to any other biomedical research projects,
- •For women : Pregnant or breastfeeding,
- •Has forfeited his/her freedom by administrative or legal award or is under guardianship,
- •Subject who, in the judgement of the investigator, is not likely to be compliant during the study,
- •Subject unable to understand the information given (for linguistic or psychiatric reasons) and to give his/her consent in writing,
- •Subject having dental braces
- •Subject having immune system disorder,
- •Subject having asthma,
- •Subject having a disease liable to interfere with study data according to the investigator,
- •Subject with teeth showing evidence of facets of attrition, premature contact, cracked enamel on the tooth to be studied and adjacent teeth,
Outcomes
Primary Outcomes
Global tolerance according to a 5-point grading scale taking into account physical signs observed and graded by the dentist and functionnal signs observed and graded by the patient
Time Frame: after 28 days
The global tolerance of the product is assessed by the dentist after 28 days of use, rated on a 5-point grading scale(good tolerance, very good tolerance, good tolerance, moderate tolerance) . The results of the global tolerance will take into account the physical signs observed by the dentist and the functional signs observed by the patients during the study
Secondary Outcomes
- Tolerance with the record of functionnal signs reported by the dentist and physical signs reported by the patient.(during 28 days)
- Acceptability of the product assessed with a questionnaire(during 28 days)
- Cold air stimulus score on the schiff cold air index as a mesure of immediate efficacy(5 and 60 minutes after application at day 1)
- Cold air stimulus score on the schiff cold air index as a mesure of efficacy(between baseline and day 28)
- Cold air stimulus score on the schiff cold air index as a mesure of short term efficacy(efficacy at day 4 and day 6)