Oral and Dental Tolerance and Efficacy on Dentinal Hypersensitivity of a Dental Gel, on Adults

NCT02466945 | Unknown

• 1 other identifier: DP30032015003
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to evaluate the tolerance and efficacy of a dental gel in patients with dentinal hypersensitivity.

Conditions

Dentinal Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• 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

  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

  after 28 days

Secondary Outcomes (5)

• 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 short term efficacy

  efficacy at day 4 and day 6

• Cold air stimulus score on the schiff cold air index as a mesure of efficacy

  between baseline and day 28

• 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

Other Outcomes (1)

• Safety of the product with the record of adverse event during the study

  during 28 days

Study Arms (1)

V063B-DP3003

OTHER

all patients will received the study product (V063B-DP3003)

Device: V063B-DP3003

Interventions

V063B-DP3003 DEVICE

The medical device V063B-DP3003 has been developed to relieve and decrease dentinal hypersensitivity in patients by creating a film around the sensitive tooth in order to prevent pain. Application modalities: apply a pea size amount of product (around 0.5g) onto each of the sensitive teeth, 3 times a day, by gentle massage with clean finger after each brushing of teeth. Do not rinse

V063B-DP3003

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Aged between18 and 70 years included
• Having signed his/her written informed consent,
• If it is a woman of childbearing potential :
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Intertek Life Sciences

Cheshire, CH66 7NZ, United Kingdom

Location

Study Officials

• GARNER Kelly

  Intertek Life Sciences

  STUDY CHAIR

• MACLURE Robert, MD

  Intertek Life Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHAMARD Christophe

CONTACT

+33 5.62.48.85.66; christophe.chamard@pierre-fabre.com

BOUYSSOUNOUSE Aurore

CONTACT

+33 5 62.48.85.67; aurore.bouyssounouse.externe@pierre-fabre.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 9, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

GB (1)