Dentin SensitivityNCT02542943
Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
A study testing Experimental Oral Rinse 1, Experimental Oral Rinse 2 and Standard fluoride toothpaste in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will investigate the longitudinal efficacy of two experimental oral rinses containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH 4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Experimental Oral Rinse 1, Experimental Oral Rinse 2 and Standard fluoride toothpaste
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- 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 55 years inclusive
- 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.
- Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- Dental health
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- At Screening:
- Self-reported history of dentinal hypersensitivity (DH) 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 qualifying evaporative air assessment (Y/N response).
- At Baseline:
- Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria:
- Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff Sensitivity Score ≥ 2)
Who cannot join
- Pregnant or breast feeding women
- Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
- 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.
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- Any condition which, in the opinion of the investigator, causes xerostomia.
- Treatment of periodontal disease within 12 months of screening
- 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.
- Recent history (within the last year) of alcohol or other substance abuse
- Dental prophylaxis within four weeks of Screening.
- Tongue or lip piercing or presence of dental implants.
- Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste 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 within eight 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, 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 toothpaste in the opinion of the investigator.
- Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening
- Individuals who require antibiotic prophylaxis for dental procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
This study will investigate the longitudinal efficacy of two experimental oral rinses containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH 4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.
- Conditions
- Dentin Sensitivity
- Being tested
- Experimental Oral Rinse 1, Experimental Oral Rinse 2, Placebo Oral Rinse, Standard fluoride toothpaste
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Oral Rinse 1Device
(1.5% w/w KOX, pH 4.5)
Experimental Oral Rinse 2Device
(1.5% w/w KOX, pH 7)
Placebo Oral RinseOther
(0% w/w KOX, pH 4.5)
Standard fluoride toothpasteDrug
1000ppm fluoride as sodium monofluorophosphate
| Study group | Role | What they receive |
|---|---|---|
| Experimental Oral Rinse1 | Experimental | Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks. Receives: Device: Experimental Oral Rinse 1; Drug: Standard fluoride toothpaste |
| Experimental Oral Rinse 2 | Experimental | Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks. Receives: Device: Experimental Oral Rinse 2; Drug: Standard fluoride toothpaste |
| Placebo Oral Rinse | Placebo comparator | Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks. Receives: Other: Placebo Oral Rinse; Drug: Standard fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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: Baseline, Week 8
Secondary outcomes (6)
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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: Baseline, Week 8
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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: Baseline, Week 4
Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
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. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.
Measured: Baseline, Week 4
Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 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. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.
Measured: Baseline, Week 8
Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain"). A reduction in the score is indicative of an improvement in sensitivity.
Measured: Baseline, Week 4
Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain"). A reduction in the score is indicative of an improvement in sensitivity.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 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
- NCT02542943
- Sponsor's protocol ID
- 204762
- Status last verified
- Jan 2017
- First submitted
- 3 Sep 2015
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT02542943
- Acronym / sponsor ID
- 204762
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 6 Mar 2017
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 investigate the longitudinal efficacy of two experimental oral rinses containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH 4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Oral Rinse1 | Experimental | Device: Experimental Oral Rinse 1, Drug: Standard fluoride toothpasteBrushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks. |
| Experimental Oral Rinse 2 | Experimental | Device: Experimental Oral Rinse 2, Drug: Standard fluoride toothpasteBrushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks. |
| Placebo Oral Rinse | Placebo comparator | Other: Placebo Oral Rinse, Drug: Standard fluoride toothpasteBrushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 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 55 years inclusive
- 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.
- Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
Key exclusion criteria (21 listed)
- Pregnant or breast feeding women
- Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
- 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.
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 |
|---|---|---|
| Experimental Oral Rinse 1(1.5% w/w KOX, pH 4.5) | Device | Experimental Oral Rinse1 |
| Experimental Oral Rinse 2(1.5% w/w KOX, pH 7) | Device | Experimental Oral Rinse 2 |
| Placebo Oral Rinse(0% w/w KOX, pH 4.5) | Other | Placebo Oral Rinse |
| Standard fluoride toothpaste1000ppm fluoride as sodium monofluorophosphate | Drug | Experimental Oral Rinse 2, Experimental Oral Rinse1, Placebo Oral Rinse |
Primary outcome
Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
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 scored as follows - 0: Participant does not respond to air stimulation; 1: 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.
6 secondary outcomes
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4
Time frame: Baseline, Week 4
Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
Time frame: Baseline, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- 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 Experimental Oral Rinse 1, Experimental Oral Rinse 2 and Standard fluoride toothpaste 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 16 inclusion and 21 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 6 Mar 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 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 of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8 (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?
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 6 Mar 2017.