The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity
Study Details
Study Description
Brief Summary
A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dentifrice containing stannous fluoride Toothpaste |
Drug: Stannous Fluoride
Test dentifrice, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute.
|
| Active Comparator: Dentifrice containing Sodium Monofluorophosphate Toothpaste |
Drug: Sodium Monofluorophosphate
Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Schiff Sensitivity Score on Day 14 [Baseline, Day 14]
Schiff sensitivity score was assessed by examiner as 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.
Secondary Outcome Measures
- Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 [Baseline, post first brushing (after 5 minutes) and Day 3]
Schiff sensitivity score was assessed by examiner as 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
- Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 [Baseline, post first brushing (after 5 minutes), Day 3 and Day 14]
Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any 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 higher the tactile threshold, the less sensitive the tooth.
Eligibility Criteria
Criteria
Inclusion
-
Demonstrates understanding of the study and willingness to participate
-
Aged at least 18 to 65 years
-
Understands and is willing, able and likely to comply with all study procedures and restrictions
-
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination.
-
Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years
-
Minimum of 20 natural teeth at screening, a minimum of two accessible teeth (incisors, canines, pre-molars)
-
At baseline, participant has two non-adjacent sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity measured by tactile stimulus (Yeaple ≤ 20g) and evaporative (air) assessment (Schiff Sensitivity Score ≥
- at baseline
Exclusion
-
Pregnant or breast-feeding women
-
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 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
-
An employee of the sponsor or the study site or members of their immediate family
-
Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
-
Any condition which, in the opinion of the investigator, causes xerostomia
-
Dental prophylaxis within 4 weeks of screening
-
Tongue or lip piercing or presence of dental implants
-
Professional desensitising treatment within 12 weeks of screening
-
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 12 weeks of screening
-
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 tooth not expected to respond to treatment with an over-the counter dentifrice in the opinion of the investigator.
-
Use of a desensitising dentifrice within six weeks of screening (participant will be required to bring their current dentifrice to the site in order to verify the lack of known anti-sensitivity ingredients)
-
Daily doses of a medication which, in the opinion of the investigator, could interfere with the perception of pain
-
Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
-
Daily doses of a medication which, in the opinion of the investigator, causes xerostomia
-
Individuals who require antibiotic prophylaxis for dental procedures
-
Any participant who, in the judgment of the investigator, should not participate in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Cork | Ireland |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202161
- RH01327
- NCT01724008
Study Results
Participant Flow
| Recruitment Details | Participants were recruited at a single center in Ireland. |
|---|---|
| Pre-assignment Detail | Total 394 participants were screened, out of which 120 participants were randomized. 274 participants were not randomized because 248 participants did not meet the study criteria, 4 participants were lost to follow up, and 7 participants withdrew the consent and 15 participants for other reasons (not-specified). |
| Arm/Group Title | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100 parts per million [ppm] as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute. | Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute. |
| Period Title: Overall Study | ||
| STARTED | 60 | 60 |
| COMPLETED | 59 | 59 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Experimental Dentifrice | Reference Dentifrice | Total |
|---|---|---|---|
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute. | Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute. | Total of all reporting groups |
| Overall Participants | 60 | 60 | 120 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
28.4
(12.85)
|
30.7
(11.66)
|
29.5
(12.27)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
35
58.3%
|
40
66.7%
|
75
62.5%
|
| Male |
25
41.7%
|
20
33.3%
|
45
37.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1
1.7%
|
1
1.7%
|
2
1.7%
|
| Not Hispanic or Latino |
59
98.3%
|
59
98.3%
|
118
98.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
1
1.7%
|
1
0.8%
|
| White |
60
100%
|
59
98.3%
|
119
99.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Change From Baseline in Schiff Sensitivity Score on Day 14 |
|---|---|
| Description | Schiff sensitivity score was assessed by examiner as 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. |
| Time Frame | Baseline, Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis for this outcome was conducted on intent-to-treat (ITT) population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time point for treatment arms respectively. |
| Arm/Group Title | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute. | Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute. |
| Measure Participants | 60 | 60 |
| At Baseline |
2.51
(0.437)
|
2.51
(0.446)
|
| At Day 14 |
1.16
(0.774)
|
1.35
(0.901)
|
| Change from Baseline on Day 14 |
-1.35
(0.727)
|
-1.16
(0.762)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Dentifrice, Reference Dentifrice |
|---|---|---|
| Comments | H0 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is zero. H1 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is not zero. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1774 |
| Comments | From ANCOVA model: Treatment as fixed factor, baseline Schiff Sensitivity score as covariate. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least square (LS) mean difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.46 to 0.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference is 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment. | |
| Title | Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 |
|---|---|
| Description | Schiff sensitivity score was assessed by examiner as 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. |
| Time Frame | Baseline, post first brushing (after 5 minutes) and Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively. |
| Arm/Group Title | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute. | Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute. |
| Measure Participants | 60 | 60 |
| After 5 minutes of brushing |
1.73
(0.826)
|
1.92
(0.737)
|
| Change after 5 minutes of brushing |
-0.78
(0.660)
|
-0.59
(0.571)
|
| On Day 3 |
1.63
(0.784)
|
1.77
(0.785)
|
| Change from baseline on Day 3 |
-0.88
(0.658)
|
-0.74
(0.568)
|
| Title | Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 |
|---|---|
| Description | Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any 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 higher the tactile threshold, the less sensitive the tooth. |
| Time Frame | Baseline, post first brushing (after 5 minutes), Day 3 and Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively. |
| Arm/Group Title | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute. | Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute. |
| Measure Participants | 60 | 60 |
| At Baseline |
10.8
(2.29)
|
11.5
(2.65)
|
| After 5 minutes of brushing |
16.5
(13.82)
|
16.7
(11.19)
|
| Change after 5 minutes of brushing |
5.7
(13.45)
|
5.2
(10.93)
|
| On Day 3 |
18.4
(17.32)
|
18.6
(16.73)
|
| Change from baseline on Day 3 |
7.5
(17.73)
|
7.1
(16.48)
|
| On Day 14 |
25.3
(22.64)
|
23.8
(22.33)
|
| Change from baseline on Day 14 |
14.6
(22.67)
|
12.3
(21.68)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Experimental Dentifrice | Reference Dentifrice | ||
| Arm/Group Description | Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute. | Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute. | ||
All Cause Mortality |
||||
| Experimental Dentifrice | Reference Dentifrice | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/60 (0%) | ||
Serious Adverse Events |
||||
| Experimental Dentifrice | Reference Dentifrice | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/60 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Experimental Dentifrice | Reference Dentifrice | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/60 (15%) | 8/60 (13.3%) | ||
| Gastrointestinal disorders | ||||
| Sensitivity of Teeth | 5/60 (8.3%) | 0/60 (0%) | ||
| Dry Mouth | 0/60 (0%) | 2/60 (3.3%) | ||
| Gingival Bleeding | 0/60 (0%) | 1/60 (1.7%) | ||
| Gingivitis | 1/60 (1.7%) | 0/60 (0%) | ||
| Mouth Ulceration | 0/60 (0%) | 1/60 (1.7%) | ||
| Toothache | 1/60 (1.7%) | 0/60 (0%) | ||
| General disorders | ||||
| Axillary Pain | 1/60 (1.7%) | 0/60 (0%) | ||
| Influenza Like Illness | 0/60 (0%) | 1/60 (1.7%) | ||
| Infections and infestations | ||||
| Oral Herpes | 0/60 (0%) | 1/60 (1.7%) | ||
| Axillary Candidiasis | 1/60 (1.7%) | 0/60 (0%) | ||
| Gastroenteritis Viral | 1/60 (1.7%) | 0/60 (0%) | ||
| Viral Infection | 0/60 (0%) | 1/60 (1.7%) | ||
| Injury, poisoning and procedural complications | ||||
| Tooth Injury | 1/60 (1.7%) | 0/60 (0%) | ||
| Nervous system disorders | ||||
| Headache | 0/60 (0%) | 1/60 (1.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Rhinitis Allergic | 1/60 (1.7%) | 0/60 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
- 202161
- RH01327
- NCT01724008