NCT04123665

A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride

Completed Phase 3 Results posted Last updated 31 January 2020

What this trial tests

Phase 3 trial testing Stannous fluoride in Gingivitis in 98 participants. Completed in 11 December 2013.

Timeline

28 May 2013

Primary endpoint
11 December 2013

11 December 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	98
Start date	28 May 2013
Primary completion	11 December 2013
Estimated completion	11 December 2013
Sites	1 location across United States

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

18 and older, 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.

Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks Primary · At Week 24

BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of approximately(app)1millimeter(mm)and run around tooth(angle of app60\[degrees(deg)\] to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth(7in each arch). 3scores were recorded buccally/labially,3scores lingually/palatally. All scorable teet

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	0.11	± 0.094
Control Sodium Monofluorophosphate Dentifrice	0.19	± 0.105

Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks Secondary · At Week 12

BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth (7in each arch). 3 scores were recorded buccally/ labially, 3scores lingually/ palatally. All scorable teeth in one quadrant were probed

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	0.11	± 0.104
Control Sodium Monofluorophosphate Dentifrice	0.23	± 0.124

Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks Secondary · At Week 12 and Week 24

BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gin

At week 12 with baseline MGI <=2.00

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	0.11	± 0.119
Control Sodium Monofluorophosphate Dentifrice	0.21	± 0.093

At week 24 with baseline MGI <=2.00

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	0.10	± 0.097
Control Sodium Monofluorophosphate Dentifrice	0.16	± 0.082

Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks Secondary · At Week 12 and Week 24

BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gin

At week 12 with baseline MGI >2.00

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	0.11	± 0.094
Control Sodium Monofluorophosphate Dentifrice	0.25	± 0.144

At week 24 with baseline MGI >2.00

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	0.12	± 0.092
Control Sodium Monofluorophosphate Dentifrice	0.21	± 0.117

Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks Secondary · At Week 12 and Week 24

MGI- to assess visual symptoms of gingivitis on facial and lingual surfaces of each scorable tooth (7 in each arch). 2scores recorded buccally/labially, 2scores lingually/palatally. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-4). Scoring was performed using standard dental light: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 plus t

At week 12

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	1.43	± 0.403
Control Sodium Monofluorophosphate Dentifrice	1.87	± 0.237

At week 24

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	1.46	± 0.373
Control Sodium Monofluorophosphate Dentifrice	1.78	± 0.316

Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks Secondary · At Week 12 and Week 24

MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:\<=2.00,High:\>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring: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

At week 12 with baseline MGI <=2.00

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	1.26	± 0.409
Control Sodium Monofluorophosphate Dentifrice	1.74	± 0.199

At week 24 with baseline MGI <=2.00

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	1.29	± 0.383
Control Sodium Monofluorophosphate Dentifrice	1.60	± 0.319

Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks Secondary · At Week 12 and Week 24

MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:\<=2.00,High:\>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring: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

At week 12 with baseline MGI >2.00

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	1.54	± 0.364
Control Sodium Monofluorophosphate Dentifrice	1.96	± 0.220

At week 24 with baseline MGI >2.00

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	1.57	± 0.324
Control Sodium Monofluorophosphate Dentifrice	1.93	± 0.231

Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks Secondary · At Week 12 and Week 24

Turesky Modification of Quigley Hein Plaque Index-to assess plaque on all gradable teeth. Participants rinsed the plaque in dye solution of 5milliliters(mL)of solution for 10 sec, then expectorated and rinsed with 10 mL of water for 10 sec and then expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-5). Disclosed plaque scored as:0

Overall analysis at week 12

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	2.60	± 0.454
Control Sodium Monofluorophosphate Dentifrice	2.90	± 0.407

Overall analysis at week 24

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	2.56	± 0.527
Control Sodium Monofluorophosphate Dentifrice	2.83	± 0.355

Interproximal analysis at week 12

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	2.82	± 0.399
Control Sodium Monofluorophosphate Dentifrice	3.05	± 0.354

Interproximal analysis at week 24

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	2.78	± 0.469
Control Sodium Monofluorophosphate Dentifrice	3.00	± 0.317

Number of Bleeding Sites After 12 and 24 Weeks Secondary · At Week 12 and Week 24

Number of gingival bleeding sites were measured as part of bleeding index via a single examiner using a color-coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. For each participant, the scoring system used to measure bleeding sites is as follows: 0= no bleeding after 30 sec, 1= bleeding upon probing after 30 sec, 2= immediate bleeding observed. Lower bleeding sites indicate better results.

At week 12

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	12.26	± 10.468
Control Sodium Monofluorophosphate Dentifrice	23.92	± 11.024

At week 24

Group	Value	95% CI
Experimental Test Stannous Fluoride Dentifrice	12.69	± 10.120
Control Sodium Monofluorophosphate Dentifrice	20.19	± 9.225

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline up to week 24. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental Test Stannous Fluoride Dentifrice

Serious: 0/50 (0%)

Deaths: 0/50

Control Sodium Monofluorophosphate Dentifrice

Serious: 0/48 (0%)

Deaths: 0/48

Other adverse events (1 terms — click to expand)

Reaction	System	Experimental Test Stannous…	Control Sodium Monofluorop…
Mouth Ulceration	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT04123665 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate and compare the gingival health of a test dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to a negative control dentifrice by comparing modified gingival index, bleeding index and plaque index scores.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Gingivitis efficacy of a 0.454% w/w stannous fluoride dentifrice: a 24-week randomized controlled trial.
   Parkinson CR, Milleman KR, Milleman JL. · · 2020 · cited 10× · PMID 32216778 · DOI 10.1186/s12903-020-01079-6