Trial Outcomes & Findings for Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity (NCT NCT02226562)
NCT ID: NCT02226562
Last Updated: 2018-08-27
Results Overview
The examiner indicated the participant's response to an evaporaitve 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 is indicative of an imrpovement in sensitivity.
COMPLETED
PHASE2
191 participants
Baseline to 8 week
2018-08-27
Participant Flow
The participants were recruited at a clinical site in the USA
Participant milestones
| Measure |
Dentifrice Plus Oral Rinse
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
|
Dentifrice Alone
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
96
|
|
Overall Study
COMPLETED
|
95
|
95
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dentifrice Plus Oral Rinse
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
|
Dentifrice Alone
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
Dentifrice Plus Oral Rinse
n=95 Participants
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
|
Dentifrice Alone
n=96 Participants
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.7 Years
STANDARD_DEVIATION 8.62 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 8.14 • n=7 Participants
|
40.7 Years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weekPopulation: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
The examiner indicated the participant's response to an evaporaitve 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 is indicative of an imrpovement in sensitivity.
Outcome measures
| Measure |
Dentifrice Plus Oral Rinse
n=95 Participants
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
|
Dentifrice Alone
n=95 Participants
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
|
|---|---|---|
|
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
|
-1.47 Score on scale
Standard Error 0.065
|
-0.37 Score on scale
Standard Error 0.065
|
SECONDARY outcome
Timeframe: Baseline to 4 weekPopulation: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
The examiner indicated the participant's response to an evaporaitve 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 is indicative of an imrpovement in sensitivity.
Outcome measures
| Measure |
Dentifrice Plus Oral Rinse
n=95 Participants
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
|
Dentifrice Alone
n=95 Participants
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
|
|---|---|---|
|
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
|
-0.94 Scores on scale
Standard Deviation 0.719
|
-0.31 Scores on scale
Standard Deviation 0.542
|
SECONDARY outcome
Timeframe: Baseline to 8 weekPopulation: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Outcome measures
| Measure |
Dentifrice Plus Oral Rinse
n=95 Participants
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
|
Dentifrice Alone
n=95 Participants
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
|
|---|---|---|
|
Mean Change From Baseline in Tactile Threshold at Week 8
|
31.32 Gram(g)
Standard Deviation 27.869
|
3.74 Gram(g)
Standard Deviation 13.188
|
SECONDARY outcome
Timeframe: Baseline to 4 weekPopulation: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Outcome measures
| Measure |
Dentifrice Plus Oral Rinse
n=95 Participants
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
|
Dentifrice Alone
n=95 Participants
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
|
|---|---|---|
|
Mean Change From Baseline in Tactile Threshold at Week 4
|
14.11 Gram (g)
Standard Deviation 21.276
|
0.74 Gram (g)
Standard Deviation 4.434
|
SECONDARY outcome
Timeframe: Baseline to 8 weekPopulation: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.
Outcome measures
| Measure |
Dentifrice Plus Oral Rinse
n=95 Participants
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
|
Dentifrice Alone
n=95 Participants
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
|
|---|---|---|
|
Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8
|
-3.05 Score on scale
Standard Deviation 2.038
|
-1.05 Score on scale
Standard Deviation 1.673
|
SECONDARY outcome
Timeframe: Baseline to 4 weekPopulation: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.
Outcome measures
| Measure |
Dentifrice Plus Oral Rinse
n=95 Participants
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
|
Dentifrice Alone
n=95 Participants
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
|
|---|---|---|
|
Mean Change From Baseline in VRS at Week 4
|
-1.64 Score on scale
Standard Deviation 1.651
|
-0.86 Score on scale
Standard Deviation 1.295
|
Adverse Events
Dentifrice Plus Oral Rinse
Dentifrice Alone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dentifrice Plus Oral Rinse
n=95 participants at risk
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
|
Dentifrice Alone
n=96 participants at risk
Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
|
|---|---|---|
|
Gastrointestinal disorders
Sensitivity of teeth
|
2.1%
2/95 • Number of events 2 • Upto 8 weeks
|
2.1%
2/96 • Number of events 2 • Upto 8 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/95 • Upto 8 weeks
|
1.0%
1/96 • Number of events 1 • Upto 8 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/95 • Upto 8 weeks
|
1.0%
1/96 • Number of events 1 • Upto 8 weeks
|
|
Gastrointestinal disorders
Tooth impacted
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.1%
2/95 • Number of events 2 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/95 • Upto 8 weeks
|
1.0%
1/96 • Number of events 1 • Upto 8 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/95 • Upto 8 weeks
|
1.0%
1/96 • Number of events 1 • Upto 8 weeks
|
|
Infections and infestations
Sinusitis
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
1.0%
1/96 • Number of events 1 • Upto 8 weeks
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
|
Injury, poisoning and procedural complications
Mouth injury
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
|
Nervous system disorders
Headache
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
|
Nervous system disorders
Migraine
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
|
General disorders
Device failure
|
0.00%
0/95 • Upto 8 weeks
|
1.0%
1/96 • Number of events 1 • Upto 8 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.1%
1/95 • Number of events 1 • Upto 8 weeks
|
0.00%
0/96 • Upto 8 weeks
|
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