Trial Outcomes & Findings for Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity (NCT NCT02371616)
NCT ID: NCT02371616
Last Updated: 2018-04-04
Results Overview
Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
COMPLETED
NA
304 participants
At Baseline and Week 8
2018-04-04
Participant Flow
Participants were recruited at one center (three sites) in United Kingdom.
A total of 731 participants were screened, out of which 304 participants were randomized. 427 participants were not randomized because 377 did not met the study criteria, 1 had adverse event, 3 were lost to follow up and 1 due to protocol violation, 5 withdrew consent and 40 participants were not randomized because of other reasons (not specified).
Participant milestones
| Measure |
Test Dentifrice
Test dentifrice containing 5% weight by weight (w/w) calcium sodium phosphosilicate and 1426 parts per million (ppm) fluoride as sodium fluoride.
|
Comparator Dentifrice
Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
154
|
|
Overall Study
COMPLETED
|
146
|
147
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Test Dentifrice
Test dentifrice containing 5% weight by weight (w/w) calcium sodium phosphosilicate and 1426 parts per million (ppm) fluoride as sodium fluoride.
|
Comparator Dentifrice
Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal of Consent
|
1
|
0
|
|
Overall Study
Other (Not specified)
|
1
|
5
|
Baseline Characteristics
Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
Baseline characteristics by cohort
| Measure |
Test Dentifrice
n=150 Participants
Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
|
Comparator Dentifrice
n=154 Participants
Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 9.43 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: Analysis for this outcome was performed on per protocol (PP) population which is defined as all participants in the intent to treat (ITT) population who had at least one assessment of efficacy considered unaffected by protocol violations.
Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Outcome measures
| Measure |
Test Dentifrice
n=147 Participants
Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
|
Comparator Dentifrice
n=149 Participants
Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
|
|---|---|---|
|
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
At Baseline
|
53.05 score on a scale
Standard Deviation 20.873
|
55.89 score on a scale
Standard Deviation 21.334
|
|
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
At Week 8
|
31.62 score on a scale
Standard Deviation 24.194
|
30.51 score on a scale
Standard Deviation 23.960
|
|
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
Change from baseline at Week 8
|
-21.50 score on a scale
Standard Deviation 22.231
|
-25.16 score on a scale
Standard Deviation 22.322
|
SECONDARY outcome
Timeframe: At Baseline and Week 4Population: Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.
Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Outcome measures
| Measure |
Test Dentifrice
n=147 Participants
Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
|
Comparator Dentifrice
n=149 Participants
Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
|
|---|---|---|
|
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4
Change from baseline at Week 4
|
-12.12 score on a scale
Standard Deviation 18.438
|
-15.24 score on a scale
Standard Deviation 19.895
|
|
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4
At Week 4
|
40.71 score on a scale
Standard Deviation 22.828
|
40.60 score on a scale
Standard Deviation 23.090
|
SECONDARY outcome
Timeframe: At Baseline, Week 4 and Week 8Population: Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.
Evaporative air sensitivity was measured by examiner as the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Outcome measures
| Measure |
Test Dentifrice
n=147 Participants
Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
|
Comparator Dentifrice
n=149 Participants
Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
|
|---|---|---|
|
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8
At Baseline
|
2.72 score on a scale
Standard Deviation 0.393
|
2.68 score on a scale
Standard Deviation 0.400
|
|
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8
At Week 4
|
2.13 score on a scale
Standard Deviation 0.771
|
2.11 score on a scale
Standard Deviation 0.832
|
|
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8
Change from baseline at Week 4
|
-0.59 score on a scale
Standard Deviation 0.689
|
-0.57 score on a scale
Standard Deviation 0.745
|
|
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8
At Week 8
|
1.65 score on a scale
Standard Deviation 0.990
|
1.58 score on a scale
Standard Deviation 1.002
|
|
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8
Change from baseline at Week 8
|
-1.08 score on a scale
Standard Deviation 0.922
|
-1.09 score on a scale
Standard Deviation 0.937
|
SECONDARY outcome
Timeframe: At Baseline, Week 4 and Week 8Population: Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.
Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force 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 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. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Outcome measures
| Measure |
Test Dentifrice
n=147 Participants
Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
|
Comparator Dentifrice
n=149 Participants
Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
|
|---|---|---|
|
Change From Baseline in Tactile Threshold at Week 4 and Week 8
At Baseline
|
12.79 gram (g)
Standard Deviation 3.419
|
12.18 gram (g)
Standard Deviation 2.982
|
|
Change From Baseline in Tactile Threshold at Week 4 and Week 8
At Week 4
|
25.45 gram (g)
Standard Deviation 20.573
|
23.61 gram (g)
Standard Deviation 18.616
|
|
Change From Baseline in Tactile Threshold at Week 4 and Week 8
Change from baseline at Week 4
|
12.72 gram (g)
Standard Deviation 20.181
|
11.42 gram (g)
Standard Deviation 18.099
|
|
Change From Baseline in Tactile Threshold at Week 4 and Week 8
At Week 8
|
32.88 gram (g)
Standard Deviation 25.392
|
33.58 gram (g)
Standard Deviation 24.840
|
|
Change From Baseline in Tactile Threshold at Week 4 and Week 8
Change from baseline at Week 8
|
20.10 gram (g)
Standard Deviation 25.041
|
21.42 gram (g)
Standard Deviation 24.450
|
Adverse Events
Test Dentifrice
Comparator Dentifrice
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Dentifrice
n=150 participants at risk
Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride.
|
Comparator Dentifrice
n=154 participants at risk
Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate.
|
|---|---|---|
|
Infections and infestations
Rhinitis
|
6.0%
9/150
|
7.8%
12/154
|
|
Infections and infestations
Oral Herpes
|
4.7%
7/150
|
1.3%
2/154
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.0%
3/150
|
3.9%
6/154
|
|
Infections and infestations
Influenza
|
1.3%
2/150
|
0.65%
1/154
|
|
Infections and infestations
Tonsillitis
|
0.67%
1/150
|
0.65%
1/154
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/150
|
1.3%
2/154
|
|
Infections and infestations
Ear Infection
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Eye Infection
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Hand-Foot-And-Mouth Disease
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Laryngitis
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Nail Infection
|
0.67%
1/150
|
0.00%
0/154
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/150
|
0.65%
1/154
|
|
Infections and infestations
Tooth Infection
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Toothache
|
2.7%
4/150
|
3.2%
5/154
|
|
Gastrointestinal disorders
Chapped Lips
|
0.67%
1/150
|
1.9%
3/154
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
1.3%
2/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/150
|
1.9%
3/154
|
|
Gastrointestinal disorders
Cheilitis
|
0.67%
1/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Gingival Pain
|
0.67%
1/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Lip Ulceration
|
0.00%
0/150
|
1.3%
2/154
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/150
|
1.3%
2/154
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/150
|
1.3%
2/154
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/150
|
1.3%
2/154
|
|
Gastrointestinal disorders
Stomatitis
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Oral Mucosal Exfoliation
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Oral Disorder
|
0.00%
0/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Oral Mucosal Erythema
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Tongue Discolouration
|
0.00%
0/150
|
0.65%
1/154
|
|
Gastrointestinal disorders
Tongue Ulceration
|
0.67%
1/150
|
0.00%
0/154
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/150
|
0.65%
1/154
|
|
Nervous system disorders
Headache
|
10.7%
16/150
|
5.2%
8/154
|
|
Nervous system disorders
Migraine
|
0.00%
0/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Lip Injury
|
1.3%
2/150
|
1.3%
2/154
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
2.0%
3/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Mouth injury
|
1.3%
2/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Traumatic Ulcer
|
0.67%
1/150
|
1.3%
2/154
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.67%
1/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
1/150
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.67%
1/150
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Laceration
|
0.67%
1/150
|
0.00%
0/154
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/150
|
0.65%
1/154
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.67%
1/150
|
0.00%
0/154
|
|
General disorders
Device Failure
|
1.3%
2/150
|
3.2%
5/154
|
|
General disorders
Application Site Discomfort
|
0.00%
0/150
|
0.65%
1/154
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
2/150
|
1.3%
2/154
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.67%
1/150
|
0.00%
0/154
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.67%
1/150
|
0.00%
0/154
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.67%
1/150
|
0.65%
1/154
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.67%
1/150
|
0.65%
1/154
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/150
|
0.65%
1/154
|
|
Psychiatric disorders
Depression
|
0.67%
1/150
|
0.00%
0/154
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/150
|
0.65%
1/154
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/150
|
0.65%
1/154
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER