Dentin HypersensitivityNCT03965039
A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
A study testing Dipotassium oxalate toothpaste, Stannous fluoride toothpaste and Potassium nitrate toothpaste in people with Dentin Hypersensitivity, run by Procter and Gamble at 1 site in United States.
Trial summary
The objective of this study is to evaluate the efficacy (changes in dentinal hypersensitivity) and safety (oral soft tissue evaluation) after use of one of four dentifrices in subjects with pre-existing hypersensitivity over an 11-week period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Dipotassium oxalate toothpaste, Stannous fluoride toothpaste and Potassium nitrate toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 3 Oct 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be at least 18 years of age;
- provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- sign a Confidentiality Disclosure Agreement (CDA);
- be in good general health as determined by the Investigator/designee;
- agree not to participate in any other oral/dental product studies during the course of this study;
- agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
Show all 11Show fewer
- agree to refrain from the use of any non-study oral hygiene products*;
- exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
- have an absence of extensive calculus above the gum line;
- agree to return for all scheduled visits and follow study procedures; and
- have two teeth with a Schiff sensitivity score > 1 in response to air challenge and a Yeaple probe score of 10-20 g in response to tactile challenge. (If these two eligible teeth are located in the same quadrant, they have to be separated by 2 other teeth.)
Who cannot join
- having taken anti-inflammatory, analgesic, or psychotropic drugs, chronically;
- chronic medical debilitating disease associated with constant or intermittent episodes of daily pain;
- any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Baseline visit;
- dental prophylaxis within 2 weeks prior to Baseline visit;
- having received professional desensitizing treatment or having used over-the-counter desensitizing products within 6 weeks of the Baseline visit;
- having periodontal surgery, orthodontic treatment, or teeth restored in the preceding three months;
Show all 21Show fewer
- having teeth or periodontium with pathology or defects likely to cause pain;
- having a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics;
- self-reported pregnancy or lactation;
- having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity;
- history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients;
- any diseases or condition that might interfere with the safe participation in the study;
- inability to undergo study procedures;
- having severe xerostomia;
- having had active caries within the 12 months;
- having high risk for caries development (rampant caries, multiple dental restorations, crowns with compromised margin) per examiners discretion;
- teeth will be excluded from study measurements if they:
- have deep, defective, or facial restorations;
- have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis;
- present with tendency for spontaneous bleeding;
- have been scaled/root planed or restored within the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
The objective of this study is to evaluate the efficacy (changes in dentinal hypersensitivity) and safety (oral soft tissue evaluation) after use of one of four dentifrices in subjects with pre-existing hypersensitivity over an 11-week period.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Dipotassium oxalate toothpaste, Stannous fluoride toothpaste, Potassium nitrate toothpaste, Sodium monofluorophosphate 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.
Dipotassium oxalate toothpasteDevice
Experimental dipotassium oxalate (3%) toothpaste
Stannous fluoride toothpasteDrug
Marketed stannous fluoride (0.454%) toothpaste
Potassium nitrate toothpasteDrug
Marketed potassium nitrate (5%) toothpaste
Sodium monofluorophosphate toothpasteDrug
Marketed sodium monofluorophosphate (0.76%) toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Marketed stannous fluoride toothpaste | Active comparator | Brush twice daily Receives: Drug: Stannous fluoride toothpaste |
| Marketed potassium nitrate toothpaste | Active comparator | Brush Twice Daily Receives: Drug: Potassium nitrate toothpaste |
| Marketed sodium monofluorophosphate toothpaste | Placebo comparator | Brush Twice Daily Receives: Drug: Sodium monofluorophosphate toothpaste |
| Experimental dipotassium oxalate toothpaste | Experimental | Brush Twice Daily Receives: Device: Dipotassium oxalate toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air Challenge
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
Measured: 4 weeks
Secondary outcomes (11)
Baseline Air Challenge
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth.
Measured: Baseline
Air Challenge
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
Measured: 3 days
Air Challenge
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
Measured: 2 weeks
Air Challenge
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
Measured: 8 weeks
Air Challenge
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluophosphate toothpaste (from week 8 to week 11).
Measured: 11 weeks
Baseline Yeaple Probe
Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.
Measured: Baseline
Tactile Threshold
Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.
Measured: 3 days
Tactile Threshold
Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.
Measured: 2 weeks
Tactile Threshold
Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.
Measured: 4 weeks
Tactile Threshold
Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.
Measured: 8 weeks
Tactile Threshold
Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluorophosphate toothpaste (from week 8 to week 11).
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start8 Jul 2019
- Primary completion3 Oct 2019
- Study completion3 Oct 2019
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 HypersensitivityStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965039
- Sponsor's protocol ID
- 2019079
- Status last verified
- Oct 2020
- First submitted
- 23 May 2019
- Last updated
- 30 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Biesbrock AR, He T, Zou Y, Grender JM, Amini P, Sagel PA, Groth A, Klukowska M. Randomized clinical trial evaluating kinetic benefits of desensitizing agents: Magnitude, onset, and stability of relief. J Periodontol. 2025 Dec;96(12):1339-1351. doi: 10.1002/JPER.24-0688. Epub 2025 May 30.
PubMed 40444818
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT03965039
- Acronym / sponsor ID
- 2019079
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Posted 30 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy (changes in dentinal hypersensitivity) and safety (oral soft tissue evaluation) after use of one of four dentifrices in subjects with pre-existing hypersensitivity over an 11-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Marketed stannous fluoride toothpaste | Active comparator | Drug: Stannous fluoride toothpasteBrush twice daily |
| Marketed potassium nitrate toothpaste | Active comparator | Drug: Potassium nitrate toothpasteBrush Twice Daily |
| Marketed sodium monofluorophosphate toothpaste | Placebo comparator | Drug: Sodium monofluorophosphate toothpasteBrush Twice Daily |
| Experimental dipotassium oxalate toothpaste | Experimental | Device: Dipotassium oxalate toothpasteBrush Twice Daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- be at least 18 years of age;
- provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- sign a Confidentiality Disclosure Agreement (CDA);
- be in good general health as determined by the Investigator/designee;
- agree not to participate in any other oral/dental product studies during the course of this study;
Key exclusion criteria (21 listed)
- having taken anti-inflammatory, analgesic, or psychotropic drugs, chronically;
- chronic medical debilitating disease associated with constant or intermittent episodes of daily pain;
- any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Baseline visit;
- dental prophylaxis within 2 weeks prior to Baseline visit;
- having received professional desensitizing treatment or having used over-the-counter desensitizing products within 6 weeks of the Baseline visit;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dipotassium oxalate toothpasteExperimental dipotassium oxalate (3%) toothpaste | Device | Experimental dipotassium oxalate toothpaste |
| Stannous fluoride toothpasteMarketed stannous fluoride (0.454%) toothpaste | Drug | Marketed stannous fluoride toothpaste |
| Potassium nitrate toothpasteMarketed potassium nitrate (5%) toothpaste | Drug | Marketed potassium nitrate toothpaste |
| Sodium monofluorophosphate toothpasteMarketed sodium monofluorophosphate (0.76%) toothpaste | Drug | Marketed sodium monofluorophosphate toothpaste |
Primary outcome
Air Challenge
Time frame: 4 weeks
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
11 secondary outcomes
Baseline Air Challenge
Time frame: Baseline
Air Challenge
Time frame: 3 days
Air Challenge
Time frame: 2 weeks
Air Challenge
Time frame: 8 weeks
Air Challenge
Time frame: 11 weeks
Baseline Yeaple Probe
Time frame: Baseline
Tactile Threshold
Time frame: 3 days
Tactile Threshold
Time frame: 2 weeks
Tactile Threshold
Time frame: 4 weeks
Tactile Threshold
Time frame: 8 weeks
Tactile Threshold
Time frame: 11 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40444818Biesbrock AR, He T, Zou Y, Grender JM, Amini P, Sagel PA, Groth A, Klukowska M. Randomized clinical trial evaluating kinetic benefits of desensitizing agents: Magnitude, onset, and stability of relief. J Periodontol. 2025 Dec;96(12):1339-1351. doi: 10.1002/JPER.24-0688. Epub 2025 May 30.
Related trials for Dentin Hypersensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity
Recruiting
Effectiveness of Two Different Desensitizing Dental Varnishes
Dentin Hypersensitivity, Dentin Desensitizing Agents
RecruitingPhase 3
Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies
Dentinal Sensitivity, Dentinal Hypersensitivity
Not yet recruiting
Evaluation of Different Non-Invasive Methods in the Treatment of Dentin Hypersensitivity Associated With Non-Carious Cervical Lesions: A Split-Mouth Clinical Study
Non-Carious Cervical Lesions (NCCLs), Dentin 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dipotassium oxalate toothpaste, Stannous fluoride toothpaste and Potassium nitrate toothpaste in people with Dentin Hypersensitivity, run by Procter and Gamble 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 11 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 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 30 Oct 2020). 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?
Air Challenge (time frame: 4 weeks). 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 NCT03965039, 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 30 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.