Dentin Sensitivity
Conditions
Brief 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.
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).
Interventions
DRUGColgate Sensitive ProRelief
A marketed dentifrice.
DRUGColgate Triple Protection
A marketed dentifrice.
DRUGTest Dentifrice
Dentifrice containing 1450 parts per million (ppm) fluoride as sodium monofluorophosphate.
Sponsors
HALEON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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: 1. No clinically significant and relevant abnormalities of medical history or physical /oral examination. 2. 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.
Exclusion criteria
* 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. * 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. 1. Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening. 2. 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. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Week 12 (Test Dentifrice Versus [vs] Negative Control Dentifrice) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4 and 8 (Test Dentifrice vs Negative Control Dentifrice) | Baseline, Weeks 2, 4, and 8 | 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. |
| Adjusted Mean Change From Baseline in Visual Analogue Scale (VAS) at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice) | Baseline, Weeks 2, 4, 8 and 12 | 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. |
| Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice) | Baseline, Weeks 2, 4, 8 and 12 | 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. |
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice) | Baseline, Weeks 2, 4, 8 and 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= 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. |
| Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice) | Baseline, Weeks 2, 4, 8 and 12 | 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. |
| Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice) | Baseline, Weeks 2, 4, 8 and 12 | 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. |
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice) | Baseline, Weeks 2, 4, 8 and 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= 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. |
| Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice) | Baseline, Weeks 2, 4, 8 and 12 | 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. |
| Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice) | Baseline, Weeks 2, 4, 8 and 12 | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMinquan Du, DSS, PhD
Wuhan University
Participant flow
Recruitment details
This study was conducted at a single center in China.
Pre-assignment details
A total of 120 participants were enrolled and randomized into three treatment groups: 42 participants to the Test Dentifrice group, 40 participants to the Comparator group and 38 participants to the Negative Control group. All 120 participants completed the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 7.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 40 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 40 | 0 / 38 |
| other Total, other adverse events | 2 / 42 | 2 / 40 | 0 / 38 |
| serious Total, serious adverse events | 0 / 42 | 0 / 40 | 0 / 38 |
Outcome results
None listed