Dentin SensitivityNCT02924350
The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH)
A study testing Stannous fluoride and Sodium monofluorophosphate in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This single center study will investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving DH compared with a standard fluoride dentifrice after short term use. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Stannous fluoride and Sodium monofluorophosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Nov 2016to 17 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consent: Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Aged 18-65 years inclusive
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination. b) Absence of any condition that would impact on the participants safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements
- At Visit 1 (Screening): a) Self-reported history of DH lasting more than six months but not more than 10 years. b) Minimum of 20 natural teeth. c) Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria: -Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR). -Tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only [Lobene, 1986] and a clinical Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response) mobility of ≤1, -Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)
- At Visit 2, Baseline (Pre-treatment):Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria:-Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2)
- Teeth which meet the EAR, MGI and mobility inclusion criteria and none of the dentition exclusion criteria at Screening should be assessed by tactile stimulus at Visit 2. Those teeth which meet the required tactile threshold (Yeaple ≤ 20g) should then be assessed by evaporative air stimulus. When two teeth that meet the study criteria are identified, no further testing is necessary
Who cannot join
- A woman who is known to be pregnant or who is intending to become pregnant over the duration of the study
- A woman who is breast-feeding
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Participation in study 205084
Show all 23Show fewer
- Recent history (within the last year) of alcohol or other substance abuse
- An employee of the sponsor or the study site or members of their immediate family The site for this protocol is the Clinical trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials unit are eligible to participate
- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes
- Any condition which, in the opinion of the investigator, causes xerostomia
- Dental prophylaxis within 4 weeks of Screening
- Tongue or lip piercing or presence of dental implants on the selected Test Teeth
- Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening
- Vital teeth bleaching within 8 weeks of Screening
- Desensitizing treatment within 8 weeks of Screening (professional sensitivity treatments and non-dentifrice sensitivity treatments)
- Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening
- Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine
- Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
- Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)
- Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs
- Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline
- Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia
- Any participants who, in the judgment of the investigator, should not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
This single center study will investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving DH compared with a standard fluoride dentifrice after short term use.
Read the detailed description
This was a single centre, 3 day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study in participants with at least two sensitive teeth that met the study criteria at the Screening and Baseline visits. Study participants were in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening. Participants were assessed at Baseline (pre-treatment), immediately after first treatment, and after 3 days twice daily treatment, to monitor clinical efficacy and safety. At the Screening visit, participants gave their written informed consent to participate in the study. Demography, medical history and concomitant medications were recorded, followed by an oral examination which included an oral soft tissue (OST) examination and assessments to determine eligible teeth. Eligible participants were supplied with a regular fluoride dentifrice (containing 1450 parts per million (ppm) fluoride as sodium monofluorophosphate) to use twice daily (morning and evening) during the acclimatisation period (4-8 weeks) between Screening and Baseline. Each brushing occasion was recorded in a product use diary. First use of the acclimatisation dentifrice was carried out under supervision at the study site. At Baseline (Day 0, pre-treatment), eligibility to continue was assessed. Following an OST examination, tooth sensitivity was assessed (first to a tactile stimulus [Yeaple probe, maximum 20 grams (g) pressure], and then to an evaporative air stimulus [Schiff sensitivity scale]), and the inclusion/exclusion criteria were reviewed. Eligible participants were stratified and randomised to treatment. First use of allocated study treatment was by direct application to the 2 selected test teeth, and was carried out under supervision at the study site. The sensitivity of the 2 test teeth was reassessed immediately post-treatment, first to a tactile stimulus (Yeaple probe, maximum 80g pressure), and then to an evaporative air stimulus (Schiff sensitivity scale). Participants completed a supervised whole mouth brushing with their allocated study treatment prior to leaving the study site. Sensitivity was re-assessed after 3 days twice daily treatment. Each use of study treatment was recorded in a product use diary. Adverse events (AEs) were documented from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product. Incidents were documented from completion of the first use of investigational product until 5 days following last administration of study product.
- Conditions
- Dentin Sensitivity
- Being tested
- Stannous fluoride, Sodium monofluorophosphate
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous fluorideOther
Supervised direct application (Day 0): Participants applied a pea-sized dose of test dentifrice to each of the 2 qualifying test teeth using their washed and clean finger to gently rub the dentifrice into the tooth's cervical margin for 60 sec. No rinsing was permitted after treatment.
Supervised brushing (Day 0, before leaving the site) and Home use (3 days): after dosing a dry toothbrush with a full strip of dentifrice, participants brushed each of the 2 qualifying test teeth first, followed by their whole mouth for at least 60 sec. Participants were permitted to rinse with 5 mL tap water (room temperature) for 5 sec. maximum after brushing on supervised brushing (Day 0) and were also permitted to rinse with tap water after brushing on home use (3 days).
Sodium monofluorophosphateOther
Supervised direct application (Day 0): participants applied a pea-sized dose of control dentifrice to each of the 2 qualifying test teeth using their washed and clean finger to gently rub the dentifrice into the tooth's cervical margin for 60 sec. No rinsing was permitted after treatment.
Supervised brushing (Day 0, before leaving the site) and home use (3 days): after dosing a dry toothbrush with a full strip of dentifrice, participants brushed their whole mouth thoroughly for at least 60 sec. Participants were permitted to rinse with 5mL tap water (room temperature) for 5 sec. maximum after brushing in supervised brushing on Day 0 and were also permitted to rinse with tap water after brushing on home use (3 days).
| Study group | Role | What they receive |
|---|---|---|
| Test dentifrice containing stannous fluoride | Experimental | All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening). Receives: Other: Stannous fluoride |
| Control dentifrice containing sodium monofluorophosphate | Active comparator | All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening). Receives: Other: Sodium monofluorophosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Schiff Sensitivity Score on Day 3
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0=Participant does not respond to air stimulation, 1=Participant responds to air stimulus but does not request discontinuation of stimulus, 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3=Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.
Measured: Baseline, Day 3
Secondary outcomes (2)
Change From Baseline (Day 0 Pre-treatment) in Schiff Sensitivity Score on Day 0 (After 60 Seconds of Single Direct Application)
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0=Participant does not respond to air stimulation, 1=Participant responds to air stimulus but does not request discontinuation of stimulus, 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3=Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.
Measured: At Baseline (Day 0 pre-treatment) and after 60 seconds of single direct application on Day 0
Change From Baseline (Day 0 Pre-treatment) in Tactile Threshold on Day 0 (After 60 Seconds of Single Direct Application) and Day 3
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10gram (g) and raised in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses were recorded as the tactile threshold. Higher tactile threshold means less sensitive tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Measured: At Baseline (Day 0 pre-treatment), after 60 seconds of single direct application on Day 0 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start7 Nov 2016
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924350
- Sponsor's protocol ID
- 207212
- Status last verified
- Feb 2018
- First submitted
- 4 Oct 2016
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT02924350
- Acronym / sponsor ID
- 207212
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 20 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single center study will investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving DH compared with a standard fluoride dentifrice after short term use.
Detailed description
This was a single centre, 3 day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study in participants with at least two sensitive teeth that met the study criteria at the Screening and Baseline visits. Study participants were in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening. Participants were assessed at Baseline (pre-treatment), immediately after first treatment, and after 3 days twice daily treatment, to monitor clinical efficacy and safety. At the Screening visit, participants gave their written informed consent to participate in the study. Demography, medical history and concomitant medications were recorded, followed by an oral examination which included an oral soft tissue (OST) examination and assessments to determine eligible teeth. Eligible participants were supplied with a regular fluoride dentifrice (containing 1450 parts per million (ppm) fluoride as sodium monofluorophosphate) to use twice daily (morning and evening) during the acclimatisation period (4-8 weeks) between Screening and Baseline. Each brushing occasion was recorded in a product use diary. First use of the acclimatisation dentifrice was carried out under supervision at the study site. At Baseline (Day 0, pre-treatment), eligibility to continue was assessed. Following an OST examination, tooth sensitivity was assessed (first to a tactile stimulus [Yeaple probe, maximum 20 grams (g) pressure], and then to an evaporative air stimulus [Schiff sensitivity scale]), and the inclusion/exclusion criteria were reviewed. Eligible participants were stratified and randomised to treatment. First use of allocated study treatment was by direct application to the 2 selected test teeth, and was carried out under supervision at the study site. The sensitivity of the 2 test teeth was reassessed immediately post-treatment, first to a tactile stimulus (Yeaple probe, maximum 80g pressure), and then to an evaporative air stimulus (Schiff sensitivity scale). Participants completed a supervised whole mouth brushing with their allocated study treatment prior to leaving the study site. Sensitivity was re-assessed after 3 days twice daily treatment. Each use of study treatment was recorded in a product use diary. Adverse events (AEs) were documented from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product. Incidents were documented from completion of the first use of investigational product until 5 days following last administration of study product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test dentifrice containing stannous fluoride | Experimental | Other: Stannous fluorideAll the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening). |
| Control dentifrice containing sodium monofluorophosphate | Active comparator | Other: Sodium monofluorophosphateAll the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Consent: Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Aged 18-65 years inclusive
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination. b) Absence of any condition that would impact on the participants safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements
- At Visit 1 (Screening): a) Self-reported history of DH lasting more than six months but not more than 10 years. b) Minimum of 20 natural teeth. c) Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria: -Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR). -Tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only [Lobene, 1986] and a clinical Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response) mobility of ≤1, -Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)
Key exclusion criteria (23 listed)
- A woman who is known to be pregnant or who is intending to become pregnant over the duration of the study
- A woman who is breast-feeding
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
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 |
|---|---|---|
| Stannous fluorideSupervised direct application (Day 0): Participants applied a pea-sized dose of test dentifrice to each of the 2 qualifying test teeth using their washed and clean finger to gently rub the dentifrice into the tooth's cervical margin for 60 sec. No rinsing was permitted after treatment. Supervised brushing (Day 0, before leaving the site) and Home use (3 days): after dosing a dry toothbrush with a full strip of dentifrice, participants brushed each of the 2 qualifying test teeth first, followed by their whole mouth for at least 60 sec. Participants were permitted to rinse with 5 mL tap water (room temperature) for 5 sec. maximum after brushing on supervised brushing (Day 0) and were also permitted to rinse with tap water after brushing on home use (3 days). | Other | Test dentifrice containing stannous fluoride |
| Sodium monofluorophosphateSupervised direct application (Day 0): participants applied a pea-sized dose of control dentifrice to each of the 2 qualifying test teeth using their washed and clean finger to gently rub the dentifrice into the tooth's cervical margin for 60 sec. No rinsing was permitted after treatment. Supervised brushing (Day 0, before leaving the site) and home use (3 days): after dosing a dry toothbrush with a full strip of dentifrice, participants brushed their whole mouth thoroughly for at least 60 sec. Participants were permitted to rinse with 5mL tap water (room temperature) for 5 sec. maximum after brushing in supervised brushing on Day 0 and were also permitted to rinse with tap water after brushing on home use (3 days). | Other | Control dentifrice containing sodium monofluorophosphate |
Primary outcome
Change From Baseline in Schiff Sensitivity Score on Day 3
Time frame: Baseline, Day 3
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0=Participant does not respond to air stimulation, 1=Participant responds to air stimulus but does not request discontinuation of stimulus, 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3=Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.
2 secondary outcomes
Change From Baseline (Day 0 Pre-treatment) in Schiff Sensitivity Score on Day 0 (After 60 Seconds of Single Direct Application)
Time frame: At Baseline (Day 0 pre-treatment) and after 60 seconds of single direct application on Day 0
Change From Baseline (Day 0 Pre-treatment) in Tactile Threshold on Day 0 (After 60 Seconds of Single Direct Application) and Day 3
Time frame: At Baseline (Day 0 pre-treatment), after 60 seconds of single direct application on Day 0 and Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stannous fluoride and Sodium monofluorophosphate in people with Dentin Sensitivity, run by GlaxoSmithKline 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 7 inclusion and 23 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: finished, as of the sponsor's last update on 20 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Schiff Sensitivity Score on Day 3 (time frame: Baseline, Day 3). 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 20 Aug 2018.