Dentin SensitivityNCT03310268
A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity
A study testing 0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in total, 1400 ppm fluoride as sodium monofluorophosphate (SMFP) and Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in total in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site in China.
Trial summary
The purpose of this study is to provide evidence of clinical efficacy of an experimental dentifrice containing stannous fluoride (SnF2) compared to regular fluoride dentifrice in the reduction of dentinal hypersensitivity (DH). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- 0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in total, 1400 ppm fluoride as sodium monofluorophosphate (SMFP) and Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in total
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2017to 2 Feb 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent indicating the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Male and female participants who, at the time of screening, are between the ages of 18 and 70 years, inclusive.
- Participants who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Good general and mental health, in the opinion of the investigator or medically qualified designee.
- Male participants able to father children and female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment. Female subjects who are not of childbearing potential must these meet requirements: Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state; have undergone a documented hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
- The following oral and dental inclusions will apply at Screening (Visit 1): Self-reported history of dentinal hypersensitivity lasting more than six months but not more than 10 years, 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 Modified Gingival Index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1, tooth with signs of sensitivity measured by a qualifying tactile stimulus (Yeaple ≤20g) qualifying evaporative air assessment (Schiff sensitivity score >=2). The following dental inclusions will apply at Baseline (Visit 2): Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤20g) and evaporative air assessment (Schiff sensitivity score ≥2). The two selected test teeth must have also qualified at Screening for this criteria. The Investigator will select two Test Teeth from those which meet both the tactile threshold and Schiff sensitivity score criteria, in addition to meeting all other criteria. Test teeth should not be adjacent to each other and preferably in different quadrants.
Who cannot join
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in another clinical study (including cosmetic studies), or receipt of an investigational drug within 30 days prior to the Screening visit and/or during study participation.
- Participation in another tooth desensitizing treatment study within 8 weeks of the Screening visit.
- Acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Pregnant female participants. This will be confirmed verbally at Screening and confirmed by Urine pregnancy testing (carried out on all female participants of child bearing potential) at the Baseline visit.
- Breastfeeding female participants.
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- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Recent history (within the last year) of alcohol or other substance abuse.
- Unwilling or unable to comply with the lifestyle guidelines described in this protocol.
- Participants who have previously been enrolled in this study.
- General oral and dental exclusions: Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing or presence of dental implants, 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, use of an over-the-counter (OTC) desensitizing product (e.g. dentifrice) and/or professional desensitizing treatment 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.
- Specific dental exclusions for test teeth: sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator, 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.
- Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
- Concomitant Medication: 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. 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 Screening and/or Baseline, Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia, Individuals who require antibiotic prophylaxis for dental procedures.
- Any participant 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 Randomized, 8 Week Clinical Study to Evaluate the Efficacy of an Experimental Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity
The purpose of this study is to provide evidence of clinical efficacy of an experimental dentifrice containing stannous fluoride (SnF2) compared to regular fluoride dentifrice in the reduction of dentinal hypersensitivity (DH). This study will be considered successful if there is a statistically significant difference in the primary efficacy variable, change from baseline in Schiff sensitivity score, after 8 weeks of treatment.
Read the detailed description
This will be a single centre, randomized, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the two selected test teeth), with a treatment period of 8 weeks. DH will be assessed following an acclimatization period of 2-6 weeks at Baseline, and after 4 and 8 weeks treatment. The study will be conducted in healthy participants with pre-existing self-reported and clinically diagnosed tooth sensitivity at Screening. A standard fluoride dentifrice with no specific anti-sensitivity, anti-gingivitis and anti-plaque activity will be included as the negative control. A Chinese marketed positive control dentifrice with sensitivity benefits (containing stannous chloride (SnCl2)) will also be included in this study.
- Conditions
- Dentin Sensitivity
- Being tested
- 0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in total, 1400 ppm fluoride as sodium monofluorophosphate (SMFP), Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in total
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in totalOther
Participants will be instructed to apply experimental dentifrice (containing 454% SnF2 and 0.072% NaF, 1450 ppm fluoride in total), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
1400 ppm fluoride as sodium monofluorophosphate (SMFP)Other
Participants will be instructed to apply negative control dentifrice (containing 1400 ppm fluoride as SMFP), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in totalOther
Participants will be instructed to apply positive control dentifrice (containing SnCl2 and 0.15% NaF, 1450 ppm fluoride in total), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Participants will be instructed to self administer experimental dentifrice containing 0.454% SnF2 and 0.072% sodium fluoride (NaF) (1450 parts per million [ppm] fluoride in total). Receives: Other: 0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in total |
| Negative Control | Active comparator | Participants will be instructed to self administer negative control dentifrice containing 1400 ppm fluoride as sodium monofluorophosphate (SMFP). Receives: Other: 1400 ppm fluoride as sodium monofluorophosphate (SMFP) |
| Positive Control | Active comparator | Participants will be instructed to self administer positive control dentifrice containing SnCl2 and 0.15% NaF (1450 ppm fluoride in total). Receives: Other: Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in total |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Schiff Sensitivity Score After 8 Weeks of Treatment
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.
Measured: Baseline, Week 8
Secondary outcomes (1)
Change From Baseline in Tactile Threshold After 8 Weeks of Treatment
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 10 grams (g) and rising 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 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: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start18 Nov 2017
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 185 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
- NCT03310268
- Sponsor's protocol ID
- 208153
- Status last verified
- Nov 2020
- First submitted
- 11 Oct 2017
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study is available via the Clinical Study Data Request site.
Publications
Tao D, Ling MR, Feng XP, Gallob J, Souverain A, Yang W, Alavi A. Efficacy of an anhydrous stannous fluoride toothpaste for relief of dentine hypersensitivity: A randomized clinical study. J Clin Periodontol. 2020 Aug;47(8):962-969. doi: 10.1111/jcpe.13305. Epub 2020 Jun 8.
PubMed 32391584
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 8 Week Clinical Study to Evaluate the Efficacy of an Experimental Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT03310268
- Acronym / sponsor ID
- 208153
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Posted 20 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide evidence of clinical efficacy of an experimental dentifrice containing stannous fluoride (SnF2) compared to regular fluoride dentifrice in the reduction of dentinal hypersensitivity (DH). This study will be considered successful if there is a statistically significant difference in the primary efficacy variable, change from baseline in Schiff sensitivity score, after 8 weeks of treatment.
Detailed description
This will be a single centre, randomized, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the two selected test teeth), with a treatment period of 8 weeks. DH will be assessed following an acclimatization period of 2-6 weeks at Baseline, and after 4 and 8 weeks treatment. The study will be conducted in healthy participants with pre-existing self-reported and clinically diagnosed tooth sensitivity at Screening. A standard fluoride dentifrice with no specific anti-sensitivity, anti-gingivitis and anti-plaque activity will be included as the negative control. A Chinese marketed positive control dentifrice with sensitivity benefits (containing stannous chloride (SnCl2)) will also be included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Other: 0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in totalParticipants will be instructed to self administer experimental dentifrice containing 0.454% SnF2 and 0.072% sodium fluoride (NaF) (1450 parts per million [ppm] fluoride in total). |
| Negative Control | Active comparator | Other: 1400 ppm fluoride as sodium monofluorophosphate (SMFP)Participants will be instructed to self administer negative control dentifrice containing 1400 ppm fluoride as sodium monofluorophosphate (SMFP). |
| Positive Control | Active comparator | Other: Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in totalParticipants will be instructed to self administer positive control dentifrice containing SnCl2 and 0.15% NaF (1450 ppm fluoride in total). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Evidence of a personally signed and dated informed consent indicating the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Male and female participants who, at the time of screening, are between the ages of 18 and 70 years, inclusive.
- Participants who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Good general and mental health, in the opinion of the investigator or medically qualified designee.
- Male participants able to father children and female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment. Female subjects who are not of childbearing potential must these meet requirements: Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state; have undergone a documented hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
Key exclusion criteria (15 listed)
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in another clinical study (including cosmetic studies), or receipt of an investigational drug within 30 days prior to the Screening visit and/or during study participation.
- Participation in another tooth desensitizing treatment study within 8 weeks of the Screening visit.
- Acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Pregnant female participants. This will be confirmed verbally at Screening and confirmed by Urine pregnancy testing (carried out on all female participants of child bearing potential) at the Baseline visit.
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 |
|---|---|---|
| 0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in totalParticipants will be instructed to apply experimental dentifrice (containing 454% SnF2 and 0.072% NaF, 1450 ppm fluoride in total), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate. | Other | Test Product |
| 1400 ppm fluoride as sodium monofluorophosphate (SMFP)Participants will be instructed to apply negative control dentifrice (containing 1400 ppm fluoride as SMFP), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate. | Other | Negative Control |
| Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in totalParticipants will be instructed to apply positive control dentifrice (containing SnCl2 and 0.15% NaF, 1450 ppm fluoride in total), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate. | Other | Positive Control |
Primary outcome
Change From Baseline in Schiff Sensitivity Score After 8 Weeks of Treatment
Time frame: Baseline, Week 8
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.
1 secondary outcome
Change From Baseline in Tactile Threshold After 8 Weeks of Treatment
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32391584Tao D, Ling MR, Feng XP, Gallob J, Souverain A, Yang W, Alavi A. Efficacy of an anhydrous stannous fluoride toothpaste for relief of dentine hypersensitivity: A randomized clinical study. J Clin Periodontol. 2020 Aug;47(8):962-969. doi: 10.1111/jcpe.13305. Epub 2020 Jun 8.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study is available via the Clinical Study Data Request site.
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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 0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in total, 1400 ppm fluoride as sodium monofluorophosphate (SMFP) and Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in total 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 6 inclusion and 15 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 27 Nov 2020. 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 20 May 2019). 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 After 8 Weeks of Treatment (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310268, which also lists 1 linked publication.
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 27 Nov 2020.