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

June 4, 2015 updated by: Pierre Fabre Dermo Cosmetique
The aim of this clinical trial is to evaluate the tolerance and efficacy of a dental gel in patients with dentinal hypersensitivity.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Cheshire, United Kingdom, CH66 7NZ
        • Intertek Life Sciences
        • Contact:
        • Principal Investigator:
          • MACLURE Robert, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: V063B-DP3003
all patients will received the study product (V063B-DP3003)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cold air stimulus score on the schiff cold air index as a mesure of immediate efficacy
Time Frame: 5 and 60 minutes after application at day 1
Immediate efficacy of the product at 5 and 60 minutes after application at day 1, according to Cold air Stimulus by delivered from a standard dental unit syringe and assessment of the score on the Schiff Cold air index with several measures.
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
Time Frame: efficacy at day 4 and day 6
Evaluate the short term efficacy of the product at Day 4 and Day 6, according to Cold air Stimulus by delivered from a standard dental unit syringe and assessment of the score on the Schiff Cold air index.
efficacy at day 4 and day 6
Cold air stimulus score on the schiff cold air index as a mesure of efficacy
Time Frame: between baseline and day 28
Evaluate the efficacy on dentinal hypersensitivity of the product between baseline and day 28, according to Cold air Stimulus by delivered from a standard dental unit syringe and assessment of the score on the Schiff Cold air index.
between baseline and day 28
Tolerance with the record of functionnal signs reported by the dentist and physical signs reported by the patient.
Time Frame: during 28 days
Evaluate the oral and dental tolerance of the studied product thanks to functionnal signs reported and graded by the patient following a scale from 0=none to 4=severe and by the clinical examination of physical signs performed and graded by the investigator with a scale from 0=none to 4=severe
during 28 days
Acceptability of the product assessed with a questionnaire
Time Frame: during 28 days
Evaluate acceptability with a questionnaire filled out by the subject on day 28.
during 28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the product with the record of adverse event during the study
Time Frame: during 28 days
collect Adverse events during the study
during 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: GARNER Kelly, Intertek Life Sciences
  • Principal Investigator: MACLURE Robert, MD, Intertek Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP30032015003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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