Dentin SensitivityNCT02937623
To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH)
A study testing Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate) in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site in United States.
Trial summary
A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after application compared to no treatment. 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?
- Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2016to 22 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 assigned and dated copy of the informed consent form.
- Aged 18-65 years.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral Examination and 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.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- At Visit 1 (Screening): a) Self-reported history of dentinal hypersensitivity (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), in different quadrants and separated by at least two teeth (or equivalent edentulous space), that meet all of the following criteria: Signs of facial/ cervical (i.e. labial/ buccal) 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 (Y/N response) on the facial/ cervical (i.e. labial/ buccal) tooth surface.
- At Visit 2, Baseline (Pre-treatment): Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) in different quadrants of the mouth and separated by at least two teeth (or equivalent edentulous space), 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) on the facial/ cervical (i.e. labial/ buccal) tooth surface.
Who cannot join
- A woman who is known to be pregnant or who are intending to become pregnant over the duration of the study.
- A women 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 and previous participation in this study.
- 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.
Show all 12Show fewer
- Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes and any condition which, in the opinion of the investigator, causes xerostomia (dry mouth).
- Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing, desensitizing treatment within 8 weeks of Screening (professional sensitivity treatments and non-dentifrice sensitivity treatments), gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening and teeth bleaching within 8 weeks of screening.
- Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of screening and tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, dental implants, 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 and daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
- 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 Proof-of-principle Clinical Study Investigating the Efficacy of a Dissolvable Strip in Providing Rapid Relief From Dentinal Hypersensitivity.
A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after application compared to no treatment.
Read the detailed description
This was a single-centre, randomized-controlled, examiner-blind, two treatment group (test and no treatment), parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth) study, in healthy participants with at least two sensitive teeth that meet all the criteria at the screening and the baseline pre-treatment visit. Participants were screened for study suitability at screening visit (Visit 1). At Visit 2 (baseline; pre-treatment) 2 non-adjacent accessible teeth (incisors, canines, premolars) in different quadrants of the mouth and separated by at least 2 teeth (or equivalent edentulous space) were identified that demonstrated signs of sensitivity as measured by a qualifying tactile stimulus (Yeaple ≤ 20 gram [g]) and evaporative air assessment (Schiff sensitivity score ≥ 2) on the facial/cervical (ie, labial/buccal) tooth surface. Once the 2 test teeth were selected, the subjects were stratified (by maximum baseline Schiff sensitivity score of the 2 selected test teeth) and randomized to treatment or no treatment. DH was assessed at baseline (pre-treatment), and 10mins, 2 \& 4 hours post-treatment.
- Conditions
- Dentin Sensitivity
- Being tested
- Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate)
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate)Device
Experimental dissolvable polymer strip containing Novamin (15% weight by weight[w/w] calcium sodium phosphosilicate).
| Study group | Role | What they receive |
|---|---|---|
| Test Product: Dissolvable polymer strip containing Novamin | Experimental | In this arm, participants received an experimental dissolvable polymer strip containing 15 % weight/weight (w/w) calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant). Receives: Device: Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate) |
| Reference Product: No treatment/product | No intervention | In this arm, participants did not receive any treatment/product. |
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 10 Minutes
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test 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 (pre-treatment) and 10 minutes post-treatment: Day 1 of the study
Secondary outcomes (3)
Change From Baseline in Schiff Sensitivity Score After 2 and 4 Hours
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test 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 (pre-treatment), 2 and 4 hours post-treatment: Day 1 of the study
Change From Baseline in Tactile Threshold After 10 Minutes, 2 Hours and 4 Hours
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 (pre-treatment), the maximum force used was 20g; at all subsequent time points (post treatment), it was 80g.
Measured: At Baseline (pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study
Change From Baseline in Numerical Rating Scale (NRS) Scores After 10 Minutes, 2 Hours and 4 Hours
Participants rated the intensity of their response to the evaporative air stimulus using a 10 point numerical rating scale of 1 (No Pain) to 10 (Intense Pain).
Measured: At baseline(pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start21 Nov 2016
- Primary completion22 Dec 2016
- Study completion22 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.
- 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
- 126 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
- NCT02937623
- Sponsor's protocol ID
- 207238
- Status last verified
- Jan 2018
- First submitted
- 17 Oct 2016
- Last updated
- 29 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Gallob J, Ling MR, Amini P, Patil A, Atassi M. Efficacy of a dissolvable strip with calcium sodium phosphosilicate (NovaMin(R)) in providing rapid dentine hypersensitivity relief. J Dent. 2019;91S:100003. doi: 10.1016/j.jjodo.2019.100003. Epub 2019 Jun 15.
PubMed 34059276
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-principle Clinical Study Investigating the Efficacy of a Dissolvable Strip in Providing Rapid Relief From Dentinal Hypersensitivity.
- ClinicalTrials.gov ID
- NCT02937623
- Acronym / sponsor ID
- 207238
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 22 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after application compared to no treatment.
Detailed description
This was a single-centre, randomized-controlled, examiner-blind, two treatment group (test and no treatment), parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth) study, in healthy participants with at least two sensitive teeth that meet all the criteria at the screening and the baseline pre-treatment visit. Participants were screened for study suitability at screening visit (Visit 1). At Visit 2 (baseline; pre-treatment) 2 non-adjacent accessible teeth (incisors, canines, premolars) in different quadrants of the mouth and separated by at least 2 teeth (or equivalent edentulous space) were identified that demonstrated signs of sensitivity as measured by a qualifying tactile stimulus (Yeaple ≤ 20 gram [g]) and evaporative air assessment (Schiff sensitivity score ≥ 2) on the facial/cervical (ie, labial/buccal) tooth surface. Once the 2 test teeth were selected, the subjects were stratified (by maximum baseline Schiff sensitivity score of the 2 selected test teeth) and randomized to treatment or no treatment. DH was assessed at baseline (pre-treatment), and 10mins, 2 \& 4 hours post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product: Dissolvable polymer strip containing Novamin | Experimental | Device: Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate)In this arm, participants received an experimental dissolvable polymer strip containing 15 % weight/weight (w/w) calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant). |
| Reference Product: No treatment/product | No intervention | –In this arm, participants did not receive any treatment/product. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received assigned and dated copy of the informed consent form.
- Aged 18-65 years.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral Examination and 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.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- At Visit 1 (Screening): a) Self-reported history of dentinal hypersensitivity (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), in different quadrants and separated by at least two teeth (or equivalent edentulous space), that meet all of the following criteria: Signs of facial/ cervical (i.e. labial/ buccal) 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 (Y/N response) on the facial/ cervical (i.e. labial/ buccal) tooth surface.
Key exclusion criteria (12 listed)
- A woman who is known to be pregnant or who are intending to become pregnant over the duration of the study.
- A women 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 and previous participation in this study.
- 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 |
|---|---|---|
| Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate)Experimental dissolvable polymer strip containing Novamin (15% weight by weight[w/w] calcium sodium phosphosilicate). | Device | Test Product: Dissolvable polymer strip containing Novamin |
Primary outcome
Change From Baseline in Schiff Sensitivity Score After 10 Minutes
Time frame: At baseline (pre-treatment) and 10 minutes post-treatment: Day 1 of the study
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test 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.
3 secondary outcomes
Change From Baseline in Schiff Sensitivity Score After 2 and 4 Hours
Time frame: At Baseline (pre-treatment), 2 and 4 hours post-treatment: Day 1 of the study
Change From Baseline in Tactile Threshold After 10 Minutes, 2 Hours and 4 Hours
Time frame: At Baseline (pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study
Change From Baseline in Numerical Rating Scale (NRS) Scores After 10 Minutes, 2 Hours and 4 Hours
Time frame: At baseline(pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34059276Gallob J, Ling MR, Amini P, Patil A, Atassi M. Efficacy of a dissolvable strip with calcium sodium phosphosilicate (NovaMin(R)) in providing rapid dentine hypersensitivity relief. J Dent. 2019;91S:100003. doi: 10.1016/j.jjodo.2019.100003. Epub 2019 Jun 15.
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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 Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate) in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site in United States.
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 12 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 29 Jan 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 States. 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 22 Dec 2017). 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 10 Minutes (time frame: At baseline (pre-treatment) and 10 minutes post-treatment: Day 1 of the study). 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 NCT02937623, 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 29 Jan 2018.