Dentin SensitivityPhase 2NCT03238352

A Study to Assess Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity

A Phase 2 study testing Potassium oxalate and Sodium fluoride in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To investigate the efficacy of an experimental oral rinse, containing 1.5% potassium oxalate (KOX) and 0 parts per million (ppm) fluoride in relieving dentine hypersensitivity (DH) after 8 weeks use compared with a placebo oral rinse and a commercialized fluoride oral rinse. 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?: Potassium oxalate and Sodium fluoride
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 1 siteUnited States
Study dates: 7 Aug 2017to 27 Oct 2017
Phase: Phase 2
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.
Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities in medical history or oral Examination and b) Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
Dental Health at 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 4 accessible non-adjacent teeth (incisors, canines, premolars), 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 ≥ 2).
Dental Health at Baseline: Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), 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.
Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone or injectable progestogen or implants of levonorgestrel or estrogenic vaginal ring or percutaneous contraceptive patches or intrauterine device or intrauterine system or double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) or male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant).
Participant will be current and regular (twice daily), users of an over the counter (OTC) Monograph or cosmetic oral rinse.
Participant will be cell phone owners so that they can contactable by SMS.

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 or 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 23Show fewer

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.
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.
Teeth bleaching and any teeth whitening procedures within 8 weeks of Screening.
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, 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 two weeks of Baseline.
Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.
Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
Any participant who, in the judgment of the investigator, should not participate in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Fort Wayne, Indiana, 46825

Other trials in United States

About this study

Official title: A Method Development Clinical Study Investigating the Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity

Read the detailed description

This will be a single centre, eight week, randomized, examiner-blind, three treatment, parallel group, stratified study. It will be conducted in healthy participants, with at least two sensitive teeth that meet all of the study criteria at the Screening and Baseline visits. DH will be assessed at Baseline, and after 4 and 8 weeks twice daily treatment.

Conditions: Dentin Sensitivity
Being tested: Potassium oxalate, Sodium fluoride, Placebo
Medical subject headings: Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Potassium oxalateDevice
Oral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride
Sodium fluorideDrug
Oral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF)
PlaceboOther
Oral rinse containing 0% KOX and 0 ppm fluoride

Study groups in NCT03238352
Study group	Role	What they receive
Test Product	Experimental	Participants will rinse twice daily (morning and evening) with 10 milliliters (mL) of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse. Receives: Device: Potassium oxalate
Negative Control	Other	Participants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse. Receives: Drug: Sodium fluoride
Placebo	Placebo comparator	Participants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Schiff Sensitivity Score
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: Week 8

Secondary outcomes (1)

Change From Baseline in Tactile Threshold
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.

7 Aug 201727 Oct 2017

First posted3 Aug 2017
Study start7 Aug 2017
Primary completion27 Oct 2017
Study completion27 Oct 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03238352
Sponsor's protocol ID: 207656
Status last verified: Oct 2018
First submitted: 19 Jul 2017
Last updated: 14 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity

All Dentin Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Method Development Clinical Study Investigating the Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity
ClinicalTrials.gov ID: NCT03238352
Acronym / sponsor ID: 207656
Conditions: Dentin Sensitivity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 7 Aug 2017 (actual)
Primary completion: 27 Oct 2017 (actual)
Study completion: 27 Oct 2017 (actual)
First posted: 3 Aug 2017 (actual)
Results: Posted 14 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Test Product	Experimental	Device: Potassium oxalateParticipants will rinse twice daily (morning and evening) with 10 milliliters (mL) of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse.
Negative Control	Other	Drug: Sodium fluorideParticipants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse.
Placebo	Placebo comparator	Other: PlaceboParticipants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 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.
Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities in medical history or oral Examination and b) Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
Dental Health at 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 4 accessible non-adjacent teeth (incisors, canines, premolars), 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 ≥ 2).
Dental Health at Baseline: Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), 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.
Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone or injectable progestogen or implants of levonorgestrel or estrogenic vaginal ring or percutaneous contraceptive patches or intrauterine device or intrauterine system or double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) or male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant).

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 or 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
Potassium oxalateOral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride	Device	Test Product
Sodium fluorideOral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF)	Drug	Negative Control
PlaceboOral rinse containing 0% KOX and 0 ppm fluoride	Other	Placebo

Primary outcome

Change From Baseline in Schiff Sensitivity Score
Time frame: 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
Time frame: Week 8

Results and safety

Results posted to the registry on 14 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)	43	43
Negative Control (0.02% w/w Sodium Fluoride)	23	20
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)	23	22

Primary outcome: Change From Baseline in Schiff Sensitivity Score

Time frame: Week 8. Mean (Standard Deviation). Unit: Score on Scale

Measure	Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) n = 43	Negative Control (0.02% w/w Sodium Fluoride) n = 20	Placebo (0% KOX, 0 Ppm Fluoride, pH 7) n = 22
Schiff score at baseline	2.59 (0.382)	2.68 (0.406)	2.52 (0.361)
Change from baseline in Schiff score at Week 8	-1.94 (0.773)	-0.75 (0.866)	-0.64 (0.848)

Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) vs Negative Control (0.02% w/w Sodium Fluoride): Difference of Least Square mean: -1.22 (95% CI -1.657 to -0.782), p <0.0001, ANCOVA
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) vs Placebo (0% KOX, 0 Ppm Fluoride, pH 7): Difference of Least Square mean: -1.28 (95% CI -1.705 to -0.858), p <.0001, ANCOVA
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) vs Negative Control (0.02% w/w Sodium Fluoride) vs Placebo (0% KOX, 0 Ppm Fluoride, pH 7): Difference of Least Square mean: -1.25 (95% CI -1.600 to -0.901), p <0.0001, ANCOVA

Population analysed: The Intent-to-Treat (ITT) (N=85) population comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)	0 of 43 (0%)	4 of 43 (9.3%)	0 of 43
Negative Control (0.02% w/w Sodium Fluoride)	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)	0 of 23 (0%)	2 of 23 (8.7%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dentin Sensitivity

Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity

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 Phase 2 study testing Potassium oxalate and Sodium fluoride 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 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 14 Nov 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 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 (time frame: 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 NCT03238352.

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 14 Nov 2018.