NCT02937636

To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population

Completed NA Results posted Last updated 14 June 2019

What this trial tests

NA trial testing Stannous fluoride in Gingivitis in 128 participants. Completed in 22 December 2017.

Timeline

19 September 2017

Primary endpoint
22 December 2017

22 December 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	128
Start date	19 September 2017
Primary completion	22 December 2017
Estimated completion	22 December 2017
Sites	1 location across China

Drugs / interventions tested

• Stannous fluoride — full drug profile →
• Sodium monofluorophosphate — full drug profile →

Conditions studied

• Gingivitis — all drugs for Gingivitis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Gingivitis. 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 Bleeding Index (BI) Primary · At Week 12

The BI was performed by a single examiner using a color coded periodontal probe. The probe was inserted approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. This measure will be analyzed and summarized over all sites.

Group	Value	95% CI
Test Product	0.07	± 0.059
Reference Product	0.15	± 0.128

Number of Bleeding Sites Secondary · At Week 12

Number of bleeding sites were measured as BI via a single examiner using a color coded periodontal probe. The probe was gently inserted approximately 1 millimeter (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.

Group	Value	95% CI
Test Product	10.37	± 8.499
Reference Product	20.92	± 15.881

Mean Modified Gingival Index (MGI) Secondary · At Week 12

The MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin).The scoring of MGI was performed by a single examiner. The MGI scoring system is as follows:0=absence of inflammation;1=mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit;2=mild inflammation; criteria as above but involving the entire marginal or papillar gingival units;3=moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit;4=severe inflamma

Group	Value	95% CI
Test Product	1.62	± 0.211
Reference Product	1.89	± 0.198

Mean Plaque Index (PI) (Overall and Interproximal) Secondary · At Week 12

The dental examiner used the PI to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider tha

Mean Plaque Index (PI) (overall)

Group	Value	95% CI
Test Product	1.85	± 0.319
Reference Product	2.19	± 0.245

Mean Plaque Index (PI) (interproximal)

Group	Value	95% CI
Test Product	1.92	± 0.313
Reference Product	2.24	± 0.240

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Product

Serious: 0/63 (0%)

Deaths: 0/63

Reference Product

Serious: 0/65 (0%)

Deaths: 0/65

Other adverse events (6 terms — click to expand)

Reaction	System	Test Product	Reference Product
SENSITIVITY OF TEETH	Gastrointestinal disorders	—	—
STOMATITIS	Gastrointestinal disorders	—	—
APHTHOUS ULCER	Gastrointestinal disorders	—	—
ORAL HERPES	Infections and infestations	—	—
NASOPHARYNGITIS	Infections and infestations	—	—
PHARYNGITIS	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT02937636 adverse events section.

Sponsor's own description

This single-centre, examiner-blind, randomized, stratified, two-treatment, parallel group clinical study will evaluate the efficacy of a 0.454% w/w stannous fluoride dentifrice compared to a reference dentifrice to control gingivitis (gingival bleeding and visual signs of gingival inflammation) in dentally and periodontally healthy adult volunteers over 12 weeks use in a Chinese population.

Publications & conference data

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