Trial Outcomes & Findings for The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity (NCT NCT01587950)

Last Updated: 2015-04-28

Results Overview

Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Baseline, immediately post administration of treatment

Results posted on

2015-04-28

Participant Flow

Participants were recruited at the clinical site.

Prior to efficacy assessment phase of this study, commercially available dental materials were employed to develop a dental stent in 3 participants. The dental stent design created a reservoir capable of holding the test solution at the cervical margin of a study tooth for at least 10 minutes. There was no efficacy data for this development phase.

Participant milestones

Participant milestones
Measure	Overall There were six study treatment regimens- 5% Potassium nitrate (KNO3) 250μl applied to an individual tooth once for 2, 5 or 10 min; 2.5% KNO3 (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Three reference treatment regimens were sterile water (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Each participant received 9 treatment regimens over three treatment visits. Three individual teeth were treated at each treatment visit. Each treatment visit was one day in length. A washout of 4 days was given after each treatment visit. Study duration for each participant during this efficacy analysis phase was approximately 5 weeks
Period 1 STARTED	12
Period 1 Received 5% KNO3 Solution (5 Minutes)	5
Period 1 Received 5% KNO3 Solution (2 Minutes)	3
Period 1 Received Sterile Water (2 Minutes)	2
Period 1 Received 5% KNO3 Solution (10 Minutes)	4
Period 1 Received 2.5% KNO3 Solution (2 Minutes)	4
Period 1 Received 2.5% KNO3 Solution (10 Minutes)	3
Period 1 Received Sterile Water (10 Minutes)	5
Period 1 Received 2.5% KNO3 Solution (5 Minutes)	5
Period 1 Received Sterile Water (5 Minutes)	5
Period 1 COMPLETED	12
Period 1 NOT COMPLETED	0
Washout 1 STARTED	12
Washout 1 COMPLETED	12
Washout 1 NOT COMPLETED	0
Period 2 STARTED	12
Period 2 Received Sterile Water (2 Minutes)	8
Period 2 Received 5% KNO3 Solution (10 Minutes)	4
Period 2 Received 2.5% KNO3 Solution (5 Minutes)	2
Period 2 Received 2.5% KNO3 Solution (10 Minutes)	6
Period 2 Received 5% KNO3 Solution (2 Minutes)	6
Period 2 Received Sterile Water (5 Minutes)	2
Period 2 Received 2.5% KNO3 Solution (2 Minutes)	4
Period 2 Received Sterile Water (10 Minutes)	2
Period 2 Received 5% KNO3 Solution (5 Minutes)	2
Period 2 COMPLETED	12
Period 2 NOT COMPLETED	0
Washout 2 STARTED	12
Washout 2 COMPLETED	12
Washout 2 NOT COMPLETED	0
Period 3 STARTED	12
Period 3 Received 2.5% KNO3 Solution (2 Minutes)	4
Period 3 Received Sterile Water (10 Minutes)	5
Period 3 Received Sterile Water (2 Minutes)	2
Period 3 Received 5% KNO3 Solution (10 Minutes)	4
Period 3 Received Sterile Water (5 Minutes)	5
Period 3 Received 5% KNO3 Solution (5 Minutes)	5
Period 3 Received 5% KNO3 Solution (2 Minutes)	3
Period 3 Received 2.5% KNO3 Solution (10 Minutes)	3
Period 3 Received 2.5% KNO3 Solution (5 Minutes)	5
Period 3 COMPLETED	12
Period 3 NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=12 Participants All randomized participants received all study treatments during this cross over study design.
Age, Continuous	39.0 Years STANDARD_DEVIATION 13.65 • n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Region of Enrollment United States	12 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, immediately post administration of treatment

Population: Intent to treat (ITT) population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to drop outs, there was difference in number of participant analyzed.

Outcome measures

Outcome measures
Measure	2.5% KNO3 Solution (2 Minutes) n=8 Participants Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.	5% KNO3 Solution (2 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.	Sterile Water (2 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.	2.5% KNO3 Solution (5 Minutes) n=7 Participants Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.	5% KNO3 Solution (5 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.	Sterile Water (5 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.	2.5% KNO3 Solution (10 Minutes) n=7 Participants Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.	5% KNO3 Solution (10 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.	Sterile Water (10 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water	-13.48 Units on a scale Interval -24.59 to -2.38	-12.49 Units on a scale Interval -22.34 to -2.64	-8.59 Units on a scale Interval -18.74 to 1.55	-14.14 Units on a scale Interval -26.13 to -2.15	-17.51 Units on a scale Interval -27.4 to -7.62	-11.12 Units on a scale Interval -20.88 to -1.36	-8.38 Units on a scale Interval -20.14 to 3.37	-17.34 Units on a scale Interval -27.15 to -7.53	-14.62 Units on a scale Interval -24.44 to -4.81

PRIMARY outcome

Timeframe: Baseline, 10 minutes post administration of treatment

Population: ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.

Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.

Outcome measures

Outcome measures
Measure	2.5% KNO3 Solution (2 Minutes) n=8 Participants Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.	5% KNO3 Solution (2 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.	Sterile Water (2 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.	2.5% KNO3 Solution (5 Minutes) n=7 Participants Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.	5% KNO3 Solution (5 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.	Sterile Water (5 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.	2.5% KNO3 Solution (10 Minutes) n=7 Participants Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.	5% KNO3 Solution (10 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.	Sterile Water (10 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water	-20.23 Units on a scale Interval -31.58 to -8.88	-13.84 Units on a scale Interval -23.92 to -3.76	-9.01 Units on a scale Interval -19.39 to 1.38	-22.67 Units on a scale Interval -34.92 to -10.42	-12.80 Units on a scale Interval -22.92 to -2.67	-11.55 Units on a scale Interval -21.55 to -1.55	-9.80 Units on a scale Interval -21.83 to 2.23	-20.81 Units on a scale Interval -30.88 to -10.74	-15.25 Units on a scale Interval -25.31 to -5.19

PRIMARY outcome

Timeframe: Baseline, 20 minutes post administration of treatment

Outcome measures

Outcome measures
Measure	2.5% KNO3 Solution (2 Minutes) n=8 Participants Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.	5% KNO3 Solution (2 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.	Sterile Water (2 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.	2.5% KNO3 Solution (5 Minutes) n=7 Participants Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.	5% KNO3 Solution (5 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.	Sterile Water (5 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.	2.5% KNO3 Solution (10 Minutes) n=7 Participants Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.	5% KNO3 Solution (10 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.	Sterile Water (10 Minutes) n=10 Participants Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water	-22.54 Units on a scale Interval -33.96 to -11.12	-20.58 Units on a scale Interval -30.88 to -10.29	-16.22 Units on a scale Interval -26.78 to -5.67	-22.25 Units on a scale Interval -34.52 to -9.98	-16.57 Units on a scale Interval -26.88 to -6.26	-18.23 Units on a scale Interval -28.46 to -8.0	-12.21 Units on a scale Interval -24.38 to -0.05	-19.97 Units on a scale Interval -30.33 to -9.61	-18.90 Units on a scale Interval -29.21 to -8.59

Adverse Events

Overall

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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