Dentin SensitivityNCT02861664
Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity
A study testing Stannous fluoride (SnF2) and Sodium monofluorophosphate (SMFP) in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site in China.
Trial summary
This study will evaluate the effectiveness of an experimental dentifrice containing stannous fluoride, an established dentine tubule occlusion technology, at reducing dentine hypersensitivity (DH) compared to a negative control dentifrice. 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 (SnF2) and Sodium monofluorophosphate (SMFP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2016to 24 Dec 2016
- 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
- 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 between 18 and 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: No clinically significant and relevant abnormalities in medical history or upon oral examination and absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements.
- At Screening-
- Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
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- Good general oral health, with a minimum of 20 natural teeth.
- 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 MGI score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Schiff sensitivity score ≥1).
- At Baseline (Visit 2)-
- Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), that meet all of the following criteria i.e.
- Tooth with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2).
Who cannot join
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are 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 and participation in another tooth desensitizing treatment study within 8 weeks of the screening visit.
- 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.
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- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes, presence of a condition which, in the opinion of the investigator is causing xerostomia.
- Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing or presence of dental implants and gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
- Teeth bleaching within 8 weeks of Screening.
- Desensitising treatment within 8 weeks of screening (professional sensitivity treatments and non-dentifrice sensitivity treatments).
- Specific Dentition Exclusions For Test Teeth
- a) Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening
- b) 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.
- C) 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).
- Any subject who, in the judgment of the investigator, should not participate in the study, any condition which in the opinion of the investigator would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- Daily doses of medication/treatments or traditional herbal ingredients/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 and examples of herbal ingredients/treatments include clove oil, olive oil, or other treatments that are directly applied to the oral cavity for the treatment of oral health conditions).
- 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.
- Individuals who require antibiotic prophylaxis for dental procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Efficacy of an Experimental Occlusion Technology Dentifrice in the Relief of Dentinal Hypersensitivity
This study will evaluate the effectiveness of an experimental dentifrice containing stannous fluoride, an established dentine tubule occlusion technology, at reducing dentine hypersensitivity (DH) compared to a negative control dentifrice. The test and control dentifrices will be administered for a total of 8 weeks, with assessments (via evaporative air and tactile stimuli) at baseline, and after 4 and 8 weeks twice-daily use.
Read the detailed description
This single centre, randomized, controlled, examiner-blind, 2 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the two selected teeth), with a treatment period of 8 weeks will investigate the clinical effectiveness of an experimental stannous fluoride dentifrice in the reduction of DH. DH will be assessed at Baseline, and after 4 and 8 weeks treatment to monitor clinical efficacy and safety.
- Conditions
- Dentin Sensitivity
- Being tested
- Stannous fluoride (SnF2), Sodium monofluorophosphate (SMFP)
- 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 fluoride (SnF2)Other
Dentifrice containing 0.454% weight by weight (w/w) SnF2 and 0.072% w/w NaF
Sodium monofluorophosphate (SMFP)Other
Dentifrice containing 1400 ppm fluoride as SMFP
| Study group | Role | What they receive |
|---|---|---|
| Test Dentifrice: Stannous fluoride (SnF2) | Experimental | Participants were instructed to apply a strip of dentifrice containing 0.454% stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF) (1450 parts per million [ppm] fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water. Receives: Other: Stannous fluoride (SnF2) |
| Negative Control Dentifrice: Sodium monofluorophosphate (SMFP) | Active comparator | Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride as sodium monofluorophosphate (SMFP) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water. Receives: Other: Sodium monofluorophosphate (SMFP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Schiff Sensitivity Score at Week 8
The examiner assessed 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 indicate improvement in sensitivity.
Measured: At Baseline and Week 8
Secondary outcomes (2)
Change From Baseline in Schiff Sensitivity Score at Week 4
The examiner assessed 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 indicate improvement in sensitivity.
Measured: At Baseline and Week 4
Change From Baseline in Tactile Threshold at Week 4 and 8
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has 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 was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Measured: At Baseline, Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start21 Sep 2016
- Primary completion1 Dec 2016
- Study completion24 Dec 2016
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
- 135 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
- NCT02861664
- Sponsor's protocol ID
- 205794
- Status last verified
- Jun 2018
- First submitted
- 5 Aug 2016
- Last updated
- 10 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of an Experimental Occlusion Technology Dentifrice in the Relief of Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT02861664
- Acronym / sponsor ID
- 205794
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 24 Dec 2016 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Posted 10 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 study will evaluate the effectiveness of an experimental dentifrice containing stannous fluoride, an established dentine tubule occlusion technology, at reducing dentine hypersensitivity (DH) compared to a negative control dentifrice. The test and control dentifrices will be administered for a total of 8 weeks, with assessments (via evaporative air and tactile stimuli) at baseline, and after 4 and 8 weeks twice-daily use.
Detailed description
This single centre, randomized, controlled, examiner-blind, 2 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the two selected teeth), with a treatment period of 8 weeks will investigate the clinical effectiveness of an experimental stannous fluoride dentifrice in the reduction of DH. DH will be assessed at Baseline, and after 4 and 8 weeks treatment to monitor clinical efficacy and safety.
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: Stannous fluoride (SnF2) | Experimental | Other: Stannous fluoride (SnF2)Participants were instructed to apply a strip of dentifrice containing 0.454% stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF) (1450 parts per million [ppm] fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water. |
| Negative Control Dentifrice: Sodium monofluorophosphate (SMFP) | Active comparator | Other: Sodium monofluorophosphate (SMFP)Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride as sodium monofluorophosphate (SMFP) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 between 18 and 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: No clinically significant and relevant abnormalities in medical history or upon oral examination and absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements.
- At Screening-
Key exclusion criteria (20 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are 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 and participation in another tooth desensitizing treatment study within 8 weeks of the screening visit.
- Recent history (within the last year) of alcohol or other substance abuse.
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 fluoride (SnF2)Dentifrice containing 0.454% weight by weight (w/w) SnF2 and 0.072% w/w NaF | Other | Test Dentifrice: Stannous fluoride (SnF2) |
| Sodium monofluorophosphate (SMFP)Dentifrice containing 1400 ppm fluoride as SMFP | Other | Negative Control Dentifrice: Sodium monofluorophosphate (SMFP) |
Primary outcome
Change From Baseline in Schiff Sensitivity Score at Week 8
Time frame: At Baseline and Week 8
The examiner assessed 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 indicate improvement in sensitivity.
2 secondary outcomes
Change From Baseline in Schiff Sensitivity Score at Week 4
Time frame: At Baseline and Week 4
Change From Baseline in Tactile Threshold at Week 4 and 8
Time frame: At Baseline, Week 4 and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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 (SnF2) and Sodium monofluorophosphate (SMFP) in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site in China.
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 11 inclusion and 20 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 10 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 China. 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 10 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 at Week 8 (time frame: At Baseline and Week 8). 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 10 Aug 2018.