NCT03072719 is a Phase 3 clinical trial of Stannous Fluoride in Dentine Hypersensitivity, sponsored by GlaxoSmithKline.

Who is sponsoring NCT03072719?

NCT03072719 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03072719?

Interventions in NCT03072719: Stannous Fluoride, Sodium Monofluorophosphate.

What condition does NCT03072719 study?

NCT03072719 studies Dentine Hypersensitivity.

Is NCT03072719 still recruiting?

NCT03072719 is currently completed. Last updated 6 March 2018.

Are results published for NCT03072719?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-03-06 · How we verify

NCT03072719

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity

Completed Phase 3 Results posted Last updated 6 March 2018

What this trial tests

Phase 3 trial testing Stannous Fluoride in Dentine Hypersensitivity in 120 participants. Completed in 12 June 2012.

Timeline

1 March 2012

Primary endpoint
1 June 2012

12 June 2012

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	120
Start date	1 March 2012
Primary completion	1 June 2012
Estimated completion	12 June 2012
Sites	1 location across Ireland

Drugs / interventions tested

Stannous Fluoride — full drug profile →
Sodium Monofluorophosphate — full drug profile →

Conditions studied

Dentine Hypersensitivity — all drugs for Dentine Hypersensitivity →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Dentine Hypersensitivity. 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.

Change From Baseline in Schiff Sensitivity Score on Day 14 Primary · 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

At Baseline

Group	Value	95% CI
Experimental Dentifrice	2.51	± 0.437
Reference Dentifrice	2.51	± 0.446

At Day 14

Group	Value	95% CI
Experimental Dentifrice	1.16	± 0.774
Reference Dentifrice	1.35	± 0.901

Change from Baseline on Day 14

Group	Value	95% CI
Experimental Dentifrice	-1.35	± 0.727
Reference Dentifrice	-1.16	± 0.762

Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 Secondary · Baseline, post first brushing (after 5 minutes) and Day 3

After 5 minutes of brushing

Group	Value	95% CI
Experimental Dentifrice	1.73	± 0.826
Reference Dentifrice	1.92	± 0.737

Change after 5 minutes of brushing

Group	Value	95% CI
Experimental Dentifrice	-0.78	± 0.660
Reference Dentifrice	-0.59	± 0.571

On Day 3

Group	Value	95% CI
Experimental Dentifrice	1.63	± 0.784
Reference Dentifrice	1.77	± 0.785

Change from baseline on Day 3

Group	Value	95% CI
Experimental Dentifrice	-0.88	± 0.658
Reference Dentifrice	-0.74	± 0.568

Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 Secondary · 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 thresh

At Baseline

Group	Value	95% CI
Experimental Dentifrice	10.8	± 2.29
Reference Dentifrice	11.5	± 2.65

After 5 minutes of brushing

Group	Value	95% CI
Experimental Dentifrice	16.5	± 13.82
Reference Dentifrice	16.7	± 11.19

Change after 5 minutes of brushing

Group	Value	95% CI
Experimental Dentifrice	5.7	± 13.45
Reference Dentifrice	5.2	± 10.93

On Day 3

Group	Value	95% CI
Experimental Dentifrice	18.4	± 17.32
Reference Dentifrice	18.6	± 16.73

Change from baseline on Day 3

Group	Value	95% CI
Experimental Dentifrice	7.5	± 17.73
Reference Dentifrice	7.1	± 16.48

On Day 14

Group	Value	95% CI
Experimental Dentifrice	25.3	± 22.64
Reference Dentifrice	23.8	± 22.33

Change from baseline on Day 14

Group	Value	95% CI
Experimental Dentifrice	14.6	± 22.67
Reference Dentifrice	12.3	± 21.68

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental Dentifrice

Serious: 0/60 (0%)

Deaths: 0/60

Reference Dentifrice

Serious: 0/60 (0%)

Deaths: 0/60

Other adverse events (15 terms — click to expand)

Reaction	System	Experimental Dentifrice	Reference Dentifrice
Sensitivity of Teeth	Gastrointestinal disorders	—	—
Dry Mouth	Gastrointestinal disorders	—	—
Gingival Bleeding	Gastrointestinal disorders	—	—
Gingivitis	Gastrointestinal disorders	—	—
Mouth Ulceration	Gastrointestinal disorders	—	—
Oral Herpes	Infections and infestations	—	—
Tooth Injury	Injury, poisoning and procedural complications	—	—
Toothache	Gastrointestinal disorders	—	—
Axillary Candidiasis	Infections and infestations	—	—
Axillary Pain	General disorders	—	—
Gastroenteritis Viral	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Influenza Like Illness	General disorders	—	—
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	—	—
Viral Infection	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT03072719 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

Verify or expand the search:

Other trials of Stannous Fluoride

Trials testing the same drug.

NCT06197555 — Comparision of the Clinical Efficacy of Different Desensitizing Toothpastes · NA · completed
NCT03943095 — Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity · Phase 2 · completed
NCT02750943 — Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease · NA · completed

Other recruiting trials for Dentine Hypersensitivity

Currently open trials in the same condition.

NCT06633627 — Neurological Responses in Patients with Dentine Hypersensitivity · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03072719 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 6 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03072719.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing