Dentinal HypersensitivityNCT02466945
Oral and Dental Tolerance and Efficacy on Dentinal Hypersensitivity of a Dental Gel, on Adults
A study testing V063B-DP3003 in people with Dentinal Hypersensitivity, run by Pierre Fabre Dermo Cosmetique at 1 site in United Kingdom.
Trial summary
The aim of this clinical trial is to evaluate the tolerance and efficacy of a dental gel in patients with dentinal hypersensitivity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dentinal Hypersensitivity
- What is being tested?
- V063B-DP3003
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Intertek Life Sciences
Cheshire, CH66 7NZ
GARNER Kelly, +44(0) 151 347 4810, Kelly.Garner@intertek.com
MACLURE Robert, MD
About this study
The aim of this clinical trial is to evaluate the tolerance and efficacy of a dental gel in patients with dentinal hypersensitivity.
Read the 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.
- Conditions
- Dentinal Hypersensitivity
- Being tested
- V063B-DP3003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V063B-DP3003Device
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
| Study group | Role | What they receive |
|---|---|---|
| V063B-DP3003 | Other | all patients will received the study product (V063B-DP3003) Receives: Device: V063B-DP3003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 28 days
Secondary outcomes (5)
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.
Measured: 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
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.
Measured: efficacy at day 4 and day 6
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.
Measured: between baseline and day 28
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
Measured: during 28 days
Acceptability of the product assessed with a questionnaire
Evaluate acceptability with a questionnaire filled out by the subject on day 28.
Measured: during 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentinal HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GARNER Kelly, Study chair, Intertek Life SciencesMACLURE Robert, MD, Principal investigator, Intertek Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466945
- Sponsor's protocol ID
- DP30032015003
- Status last verified
- Jun 2015
- First submitted
- 1 Jun 2015
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral and Dental Tolerance and Efficacy on Dentinal Hypersensitivity of a Dental Gel, on Adults
- ClinicalTrials.gov ID
- NCT02466945
- Acronym / sponsor ID
- DP30032015003
- Conditions
- Dentinal Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V063B-DP3003 | Other | Device: V063B-DP3003all patients will received the study product (V063B-DP3003) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (26 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V063B-DP3003The 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 | Device | V063B-DP3003 |
Primary outcome
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
5 secondary outcomes
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
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
Cold air stimulus score on the schiff cold air index as a mesure of efficacy
Time frame: 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
Acceptability of the product assessed with a questionnaire
Time frame: during 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GARNER Kelly study chair
Intertek Life Sciences
MACLURE Robert, MD principal investigator
Intertek Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V063B-DP3003 in people with Dentinal Hypersensitivity, run by Pierre Fabre Dermo Cosmetique at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHAMARD Christophe (+33 5.62.48.85.66, christophe.chamard@pierre-fabre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: after 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.