Back to resultsOral and Dental Tolerance and Efficacy on Dentinal Hypersensitivity of a Dental Gel, on Adults
Primary Purpose
Dentinal Hypersensitivity
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
V063B-DP3003
Sponsored by
About this trial
This is an interventional treatment trial for Dentinal Hypersensitivity
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
Sites / Locations
- Intertek Life Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
V063B-DP3003
Arm Description
all patients will received the study product (V063B-DP3003)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Cold air stimulus score on the schiff cold air index as a mesure of immediate efficacy
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.
Cold air stimulus score on the schiff cold air index as a mesure of short term efficacy
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.
Cold air stimulus score on the schiff cold air index as a mesure of efficacy
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.
Tolerance with the record of functionnal signs reported by the dentist and physical signs reported by the patient.
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
Acceptability of the product assessed with a questionnaire
Evaluate acceptability with a questionnaire filled out by the subject on day 28.
Full Information
NCT ID
NCT02466945
First Posted
June 1, 2015
Last Updated
June 4, 2015
Sponsor
Pierre Fabre Dermo Cosmetique
1. Study Identification
Unique Protocol Identification Number
NCT02466945
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Dermo Cosmetique
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentinal Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
V063B-DP3003
Arm Type
Other
Arm Description
all patients will received the study product (V063B-DP3003)
Intervention Type
Device
Intervention Name(s)
V063B-DP3003
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
after 28 days
Secondary Outcome Measure Information:
Title
Cold air stimulus score on the schiff cold air index as a mesure of immediate efficacy
Description
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.
Time Frame
5 and 60 minutes after application at day 1
Title
Cold air stimulus score on the schiff cold air index as a mesure of short term efficacy
Description
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.
Time Frame
efficacy at day 4 and day 6
Title
Cold air stimulus score on the schiff cold air index as a mesure of efficacy
Description
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.
Time Frame
between baseline and day 28
Title
Tolerance with the record of functionnal signs reported by the dentist and physical signs reported by the patient.
Description
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
Time Frame
during 28 days
Title
Acceptability of the product assessed with a questionnaire
Description
Evaluate acceptability with a questionnaire filled out by the subject on day 28.
Time Frame
during 28 days
Other Pre-specified Outcome Measures:
Title
Safety of the product with the record of adverse event during the study
Description
collect Adverse events during the study
Time Frame
during 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHAMARD Christophe
Phone
+33 5.62.48.85.66
Email
christophe.chamard@pierre-fabre.com
First Name & Middle Initial & Last Name or Official Title & Degree
BOUYSSOUNOUSE Aurore
Phone
+33 5 62.48.85.67
Email
aurore.bouyssounouse.externe@pierre-fabre.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GARNER Kelly
Organizational Affiliation
Intertek Life Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
MACLURE Robert, MD
Organizational Affiliation
Intertek Life Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intertek Life Sciences
City
Cheshire
ZIP/Postal Code
CH66 7NZ
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GARNER Kelly
Phone
+44(0) 151 347 4810
Email
Kelly.Garner@intertek.com
First Name & Middle Initial & Last Name & Degree
MACLURE Robert, MD
12. IPD Sharing Statement
Learn more about this trial
Oral and Dental Tolerance and Efficacy on Dentinal Hypersensitivity of a Dental Gel, on Adults
We'll reach out to this number within 24 hrs