Clinical trial NCT02466945: Oral and Dental Tolerance and Efficacy on Dentinal Hypersensitivity of a Dental Gel, on Adults
Official title: Oral and Dental Tolerance and Efficacy on Dentinal Hypersensitivity of a Dental Gel, on Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dentinal Hypersensitivity
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2015-06-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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,
* Subject with a mild to moderate dentinal hypersensitivity on at least 2 hypersensitive non adjacent teeth: with a Schiff cold air index from 1 to 2
* Subjects who show a response typical of sensitivity to the cold air blast at visit 1.

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,
* Subject with teeth showing evidence of irreversible pulpitis and active periodontal disease,
* Subject having caries on the tooth to be studied and adjacent teeth
* Subject having restauration of any type in the tooth to be studied,
* Subject having occlusal overload or occlusal adjustment recently made in the tooth to be studied,
* Subject with crowns , bridges in the area of sensitivity,
* Subject had undergone professional desensitizing therapy during the 3 previous months,
* Subject having a cutaneous-mucosal disease liable to interfere with study data according to the investigator, especially: herpes or medical history herpes, aphtous and medical history of aphtous, lichen planus, chronic lupus erythematosis,
* Subject having undergone surgery, chemical or physical treatment to the concerned study area in the last 3 months,
* Subject allergic or intolerant to one of the components of the study product,
* Subject having a background of intolerance or allergy to cosmetics, drugs or to other substances (fruits, lactose intolerant, nuts, etc.),
* Subject planning to have any dental care during the study.
* Subject having a treatment liable to interfere with study data (aspirin or derivatives, anti-inflammatories, and other analgesic, antibiotics, antihistaminics, corticoids, desensitizing substances, immunosuppressants, calcic inhibitors and anticonvulsants) 2 days before the inclusion visit,
* Subject having used of over the counter product for dentinal hypersensitivity within the previous six weeks,
* Subject being vaccinated (4 weeks prior) or expecting to be vaccinated during the study,
* Subject having modified his/her cosmetic habits (on the areas concerned by the study) during the last 2 weeks,
* Subject having applied any local product the day of the inclusion visit on the study area except the usual toothpaste

Primary outcomes:
measure: 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
timeFrame: after 28 days
Secondary outcomes:
measure: Cold air stimulus score on the schiff cold air index as a mesure of immediate efficacy
timeFrame: 5 and 60 minutes after application at day 1
measure: Cold air stimulus score on the schiff cold air index as a mesure of short term efficacy
timeFrame: efficacy at day 4 and day 6
measure: Cold air stimulus score on the schiff cold air index as a mesure of efficacy
timeFrame: between baseline and day 28
measure: Tolerance with the record of functionnal signs reported by the dentist and physical signs reported by the patient.
timeFrame: during 28 days
measure: Acceptability of the product assessed with a questionnaire
timeFrame: during 28 days
Other outcomes:
measure: Safety of the product with the record of adverse event during the study
timeFrame: during 28 days
Locations:
city: Cheshire
country: United Kingdom
facility: Intertek Life Sciences
Study officials:
affiliation: Intertek Life Sciences
name: GARNER Kelly
role: STUDY_CHAIR
affiliation: Intertek Life Sciences
name: MACLURE Robert, MD
role: PRINCIPAL_INVESTIGATOR
References: