Dentin SensitivityNCT07317128
Study to Evaluate the Effectiveness of Test Dentifrice in the Relief of Dentinal Hypersensitivity
A study testing Test Dentifrice, Colgate Sensitive ProRelief and Colgate Triple Protection in people with Dentin Sensitivity, run by HALEON at 1 site in China.
Trial summary
The purpose of this study is to compare the clinical efficacy of test fluoride dentifrice in reducing Dentin Hypersensitivity (DH) with that of a standard fluoride dentifrice, as measured by evaporative air sensitivity after 12 weeks twice daily brushing. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Test Dentifrice, Colgate Sensitive ProRelief and Colgate Triple Protection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2013to 8 Jun 2013
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant demonstrates understanding of the study and is willing to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Participant is 18 to 60 years of age.
- Participant understands and is willing, able and likely to comply all study procedures and restrictions.
- Participant with good general and mental health, in the opinion of the investigator or medically qualified designee:
- No clinically significant and relevant abnormalities of medical history or physical /oral examination.
- Absence of any condition that would impact on the participant's safety or wellbeing or affect the participant's ability to understand and follow study procedures and requirements.
- Self-reported history of DH lasting more than 6 months but not more than 10 years and minimum of 20 natural teeth.
Who cannot join
- Female participant who is known to be pregnant or who is intending to become pregnant over the duration of the study.
- Female participant who is breast-feeding.
- Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation is in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit.
- Participant who has had tooth desensitizing treatment within 8 weeks of Screening visit (professional sensitivity treatments and non-dentifrice sensitivity treatments).
- Participant who had previously participated in this study.
Show all 23Show fewer
- Participant with a recent history (within the last year) of alcohol or other substance abuse.
- Participant who is an employee of the sponsor or the study site or members of their immediate family.
- Participant with presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- Participant with any condition or daily doses of a medication which, in the opinion of the investigator, is causing xerostomia.
- Participant with dental prophylaxis within 4 weeks of screening.
- Participant with tongue or lip piercing or presence of dental implants.
- Participant with gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening.
- Participant who did teeth bleaching within 8 weeks of screening.
- Participant with Specific Dentition Exclusions for Test teeth.
- Tooth with evidence of current or recent caries, or reported treatment of decay in 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 teeth are not expected, in the opinion of the investigator, to respond to treatment with an over-the-counter dentifrice.
- Participant who has used product of a sensitivity dentifrice within 8 weeks of screening.
- Participant who had daily doses of a medication or traditional herbal ingredients or 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, tranquilizers, mood-altering and anti-inflammatory drugs. Examples of herbal ingredients/treatments include clove oil, olive oil, or other treatments that are directly applied to the oral cavity for the treatment of oral health problems.
- Participant who is currently taking a course of antibiotics or has taken a course of antibiotics within 2 weeks of baseline.
- Participant who had dental procedures or participant who require antibiotic prophylaxis for dental procedures.
- Any participant who, in the opinion of the investigator, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
School and Hospital of Stomatology, Wuhan University
Wuhan, Hubei, 430079
About this study
Official title: Study to Evaluate the Efficacy of Two Occlusion Technology Dentifrices in the Relief of Dentinal Hypersensitivity
The purpose of this study is to compare the clinical efficacy of test fluoride dentifrice in reducing Dentin Hypersensitivity (DH) with that of a standard fluoride dentifrice, as measured by evaporative air sensitivity after 12 weeks twice daily brushing.
Read the detailed description
A randomized, examiner blind, three treatment arm, parallel group design with a treatment period of 12 weeks. Approximately 275 participants will be screened to ensure that approximately 120 participants to be randomized (approximately 40 to each treatment group) and at least 114 participants to complete the study (approximately 38 per treatment group).
- Conditions
- Dentin Sensitivity
- Being tested
- Test Dentifrice, Colgate Sensitive ProRelief, Colgate Triple Protection
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test DentifriceDrug
Dentifrice containing 1450 parts per million (ppm) fluoride as sodium monofluorophosphate.
Colgate Sensitive ProReliefDrug
A marketed dentifrice.
Colgate Triple ProtectionDrug
A marketed dentifrice.
| Study group | Role | What they receive |
|---|---|---|
| Test Dentifrice | Experimental | Participants will be instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period. Receives: Drug: Test Dentifrice |
| Comparator Dentifrice | Active comparator | Participants will be instructed to apply a full ribbon of the comparator dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period. Receives: Drug: Colgate Sensitive ProRelief |
| Negative Control Dentifrice | Active comparator | Participants will be instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period. Receives: Drug: Colgate Triple Protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Week 12 (Test Dentifrice Versus [vs] Negative Control Dentifrice)
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0 equal to (=) no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. Lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoint.
Measured: Baseline and Week 12
Secondary outcomes (9)
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4 and 8 (Test Dentifrice vs Negative Control Dentifrice)
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0= no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. Lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoints.
Measured: Baseline, Weeks 2, 4, and 8
Adjusted Mean Change From Baseline in Visual Analogue Scale (VAS) at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Evaporative (air) sensitivity was assessed on the test teeth by applying a 1-second air stimulus from a standard dental syringe. Participants rated the intensity of their response to the evaporative (air) stimulus using a 100 millimeter (mm) VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Measured: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Tactile sensitivity was assessed for eligible teeth using a constant pressure probe (Yeaple probe). After each application of the stimulus, participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (grams [g]). Higher tactile threshold indicated a better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Measured: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0= no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. Lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoints.
Measured: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Evaporative (air) sensitivity was assessed on the test teeth by applying a 1-second air stimulus from a standard dental syringe. Participants rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Measured: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Tactile sensitivity was assessed for eligible teeth using a constant pressure probe (Yeaple probe). After each application of the stimulus, participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Measured: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0= no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. Lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoints.
Measured: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Evaporative (air) sensitivity was assessed on the test teeth by applying a 1-second air stimulus from a standard dental syringe. Participants rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Measured: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Tactile sensitivity was assessed for eligible teeth using a constant pressure probe (Yeaple probe). After each application of the stimulus, participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Measured: Baseline, Weeks 2, 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start20 Jan 2013
- Primary completion8 Jun 2013
- Study completion8 Jun 2013
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.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minquan Du, DSS, PhD, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317128
- Sponsor's protocol ID
- RH01748
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2025
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy of Two Occlusion Technology Dentifrices in the Relief of Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT07317128
- Acronym / sponsor ID
- RH01748
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2013 (actual)
- Primary completion
- 8 Jun 2013 (actual)
- Study completion
- 8 Jun 2013 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Posted 13 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the clinical efficacy of test fluoride dentifrice in reducing Dentin Hypersensitivity (DH) with that of a standard fluoride dentifrice, as measured by evaporative air sensitivity after 12 weeks twice daily brushing.
Detailed description
A randomized, examiner blind, three treatment arm, parallel group design with a treatment period of 12 weeks. Approximately 275 participants will be screened to ensure that approximately 120 participants to be randomized (approximately 40 to each treatment group) and at least 114 participants to complete the study (approximately 38 per treatment group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Dentifrice | Experimental | Drug: Test DentifriceParticipants will be instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period. |
| Comparator Dentifrice | Active comparator | Drug: Colgate Sensitive ProReliefParticipants will be instructed to apply a full ribbon of the comparator dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period. |
| Negative Control Dentifrice | Active comparator | Drug: Colgate Triple ProtectionParticipants will be instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant demonstrates understanding of the study and is willing to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Participant is 18 to 60 years of age.
- Participant understands and is willing, able and likely to comply all study procedures and restrictions.
- Participant with good general and mental health, in the opinion of the investigator or medically qualified designee:
- Self-reported history of DH lasting more than 6 months but not more than 10 years and minimum of 20 natural teeth.
Key exclusion criteria (23 listed)
- Female participant who is known to be pregnant or who is intending to become pregnant over the duration of the study.
- Female participant who is breast-feeding.
- Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation is in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit.
- Participant who has had tooth desensitizing treatment within 8 weeks of Screening visit (professional sensitivity treatments and non-dentifrice sensitivity treatments).
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 |
|---|---|---|
| Test DentifriceDentifrice containing 1450 parts per million (ppm) fluoride as sodium monofluorophosphate. | Drug | Test Dentifrice |
| Colgate Sensitive ProReliefA marketed dentifrice. | Drug | Comparator Dentifrice |
| Colgate Triple ProtectionA marketed dentifrice. | Drug | Negative Control Dentifrice |
Primary outcome
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Week 12 (Test Dentifrice Versus [vs] Negative Control Dentifrice)
Time frame: Baseline and Week 12
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0 equal to (=) no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. Lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoint.
9 secondary outcomes
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4 and 8 (Test Dentifrice vs Negative Control Dentifrice)
Time frame: Baseline, Weeks 2, 4, and 8
Adjusted Mean Change From Baseline in Visual Analogue Scale (VAS) at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Time frame: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Time frame: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Time frame: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Time frame: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Time frame: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Time frame: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Time frame: Baseline, Weeks 2, 4, 8 and 12
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Time frame: Baseline, Weeks 2, 4, 8 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
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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.
Minquan Du, DSS, PhD principal investigator
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Dentifrice, Colgate Sensitive ProRelief and Colgate Triple Protection in people with Dentin Sensitivity, run by HALEON at 1 site in China.
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 13 May 2026. 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 China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2026). 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?
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Week 12 (Test Dentifrice Versus [vs] Negative Control Dentifrice) (time frame: Baseline and Week 12). 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 13 May 2026.