NCT03943095

Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity

Completed Phase 2 Results posted Last updated 11 September 2020

What this trial tests

Phase 2 trial testing Potassium Nitrate in Dentin Hypersensitivity in 123 participants. Completed in 28 August 2019.

Timeline

13 May 2019

Primary endpoint
28 August 2019

28 August 2019

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	123
Start date	13 May 2019
Primary completion	28 August 2019
Estimated completion	28 August 2019
Sites	1 location across Canada

Drugs / interventions tested

• Potassium Nitrate (POTASSIUM NITRATE) — full drug profile →
• Stannous Fluoride — full drug profile →

Conditions studied

• Dentin Hypersensitivity — all drugs for Dentin Hypersensitivity →
• Dentin Sensitivity — all drugs for Dentin Sensitivity →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Dentin Hypersensitivity or Dentin Sensitivity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0) Primary · Baseline (Day 0)

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 millimeter (mm) coronal to the gingival margin from a distance of approximately 1 centimeter (cm).Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not r

Group	Value	95% CI
Test Dentifrice	2.61	± 0.063
Control Dentifrice	2.60	± 0.063

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3 Primary · Day 3

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discon

Group	Value	95% CI
Test Dentifrice	1.19	± 0.104
Control Dentifrice	1.46	± 0.104

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 7 Primary · Day 7

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discon

Group	Value	95% CI
Test Dentifrice	0.73	± 0.097
Control Dentifrice	1.20	± 0.120

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14 Primary · Day 14

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discon

Group	Value	95% CI
Test Dentifrice	0.52	± 0.085
Control Dentifrice	1.07	± 0.134

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28 Primary · Day 28

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discon

Group	Value	95% CI
Test Dentifrice	0.32	± 0.087
Control Dentifrice	0.75	± 0.121

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56 Primary · Day 56

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discon

Group	Value	95% CI
Test Dentifrice	0.12	± 0.043
Control Dentifrice	0.42	± 0.100

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0) Primary · Baseline (Day 0)

Tactile sensitivity was assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 gram (g) and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached.The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application,the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tact

Group	Value	95% CI
Test Dentifrice	11.06	± 0.372
Control Dentifrice	12.31	± 0.574

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3 Primary · Day 3

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tac

Group	Value	95% CI
Test Dentifrice	31.35	± 2.087
Control Dentifrice	27.98	± 2.061

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 7 Primary · Day 7

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tac

Group	Value	95% CI
Test Dentifrice	47.45	± 3.075
Control Dentifrice	38.75	± 2.983

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14 Primary · Day 14

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tac

Group	Value	95% CI
Test Dentifrice	60.59	± 3.271
Control Dentifrice	48.53	± 3.549

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28 Primary · Day 28

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tac

Group	Value	95% CI
Test Dentifrice	71.67	± 3.044
Control Dentifrice	57.94	± 4.076

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56 Primary · Day 56

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tac

Group	Value	95% CI
Test Dentifrice	79.71	± 2.390
Control Dentifrice	64.80	± 3.921

Adverse events — posted to ClinicalTrials.gov

Time frame: From screening up to Day 56. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Dentifrice

Serious: 0/52 (0%)

Deaths: 0/52

Control Dentifrice

Serious: 0/52 (0%)

Deaths: 0/52

Other adverse events (2 terms — click to expand)

Reaction	System	Test Dentifrice	Control Dentifrice
Oral mucosal exfoliation	Gastrointestinal disorders	—	—
Mouth injury	Injury, poisoning and procedural complications	—	—

Data from ClinicalTrials.gov NCT03943095 adverse events section.

Sponsor's own description

This exploratory study will characterize the efficacy profile of an experimental dual active 5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.