Dentin SensitivityNCT02651467
A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.
A study testing Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0) and Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5) in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants. 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?
- Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0) and Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2016to 22 Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Participants will be male or female aged between 18 and 65 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 participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- Self-reported history of dentinal hypersensitivity (DH) lasting more than(>) six months but not > 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 at screening and minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) at baseline.
Who cannot join
- Women who are pregnant or breast-feeding .
- 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.
Show all 21Show fewer
- Any condition which, in the opinion of the investigator, causes xerostomia.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
- 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.
- 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 Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.
- Conditions
- Dentin Sensitivity
- Being tested
- Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0), Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5), Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
- 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 1 (1.5% w/w KOX, 0ppm F, pH 7.0)Other
1.5% w/w KOX, 0ppm F, pH 7.0
Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)Other
2.0% w/w KOX, 45ppm F, pH 4.5
Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )Other
0% w/w KOX 0ppm F, pH 4.5
| Study group | Role | What they receive |
|---|---|---|
| Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0) | Experimental | Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 1 (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks. Receives: Other: Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0) |
| Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5) | Experimental | Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 2 (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks. Receives: Other: Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5) |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Placebo comparator | Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks. Receives: Other: Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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.
Measured: Baseline and Week 8
Secondary outcomes (4)
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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.
Measured: Baseline and Week 8
Change From Baseline in Schiff Sensitivity Score at Week 4
Schiff sensitivity score was assessed as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of syimulus; 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.
Measured: Baseline and Week 4
Change From Baseline in Tactile Threshold at Week 4 and 8
Pressure was administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. 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 greater the tactile threshold, the less sensitive the tooth.
Measured: Baseline, Week 4 and 8
Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain").
Measured: Baseline, Week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start4 Jan 2016
- Primary completion1 Apr 2016
- Study completion22 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 221 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
- NCT02651467
- Sponsor's protocol ID
- 204763
- Status last verified
- Jul 2018
- First submitted
- 7 Jan 2016
- Last updated
- 27 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. 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
- NCT02651467
- Acronym / sponsor ID
- 204763
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2016
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 22 Apr 2016 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Posted 9 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 will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.
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 Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0) | Experimental | Other: Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 1 (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks. |
| Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5) | Experimental | Other: Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 2 (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks. |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Placebo comparator | Other: Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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.
- Participants will be male or female aged between 18 and 65 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 participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
Key exclusion criteria (21 listed)
- Women who are pregnant or breast-feeding .
- 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.
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, 0ppm F, pH 7.0)1.5% w/w KOX, 0ppm F, pH 7.0 | Other | Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0) |
| Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)2.0% w/w KOX, 45ppm F, pH 4.5 | Other | Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5) |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )0% w/w KOX 0ppm F, pH 4.5 | Other | Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) |
Primary outcome
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)
Time frame: Baseline and Week 8
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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.
4 secondary outcomes
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)
Time frame: Baseline and Week 8
Change From Baseline in Schiff Sensitivity Score at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Tactile Threshold at Week 4 and 8
Time frame: Baseline, Week 4 and 8
Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8
Time frame: Baseline, Week 4 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0) and Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5) 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 8 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 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 9 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 at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.