To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This clinical study will be carried out in healthy adult volunteers with moderate gingivitis. Treatment effect will be determined by evaluating the efficacy, in a Chinese population, of a dentifrice containing 0.454% w/w stannous fluoride to control gingivitis and supra-gingival plaque following 6 and 12 weeks twice daily brushing, compared to a fluoride control dentifrice. During the 12 week treatment period, participant will brush with their allocated study product twice daily.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test Product Participants will apply a full strip of dentifrice to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. |
Other: Stannous fluoride
Experimental dentifrice containing 0.454% w/w stannous fluoride & 0.0721% w/w sodium fluoride containing1450 parts per million (ppm) fluoride
|
| Active Comparator: Reference Product Participants will apply a full strip of dentifrice to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. |
Other: Sodium monofluorophosphate
Dentifrice containing 0.14% w/w sodium monofluorophosphate containing1400 ppm fluoride
|
Outcome Measures
Primary Outcome Measures
- Mean Bleeding Index (BI) [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.
Secondary Outcome Measures
- Number of Bleeding Sites [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.
- Mean Modified Gingival Index (MGI) [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 inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.
- Mean Plaque Index (PI) (Overall and Interproximal) [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 than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.Overall PI score and interproximal PI score were calculated as the mean PI over all tooth sites and mean PI over interproximal sites (distal and mesial) respectively.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
-
Aged 18 to 65 years.
-
Understands and is willing, able and likely to comply with all study procedures and restrictions.
-
Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination, absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
-
A minimum of 20 natural teeth (all teeth; incisors, canines, pre-molars & molars), and a minimum of 40 gradable surfaces for MGI, BI and PI. A scorable surface is defined as a surface that has 50% of the surface gradable for each clinical index. Third molars, orthodontically banded/bonded, fully crowned or extensively restored or grossly carious teeth are not included in the tooth count, moderate gingivitis present at the screening visit (in the opinion of the clinical examiner from a gross visual examination) and mean whole mouth MGI between 1.75 and 2.30 and a mean overall PI score >1.5 at Baseline visit.
Exclusion Criteria:
-
Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
-
Women who are breast-feeding
-
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
-
Screening: Currently taking antibiotics or requiring antibiotic use prior to dental prophylaxis or other dental procedures, currently taking an anti-inflammatory medication or traditional Chinese medicines (TCM) which, in the opinion of the Investigator, could affect gingival condition, currently taking a systemic medication which, in the opinion of the Investigator, could affect gingival condition (e.g. calcium channel blockers, or aspirin therapy).
-
Baseline (Visit 2): Has taken, or currently taking, antibiotics in the previous 14 days, or an anti-inflammatory medication or a systemic medication days (e.g. calcium channel blockers, or aspirin therapy) which, in the opinion of the Investigator, could affect gingival condition in the previous 14 days.
-
Have current active caries or periodontitis that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, restorations in a poor state of repair, partial dentures or orthodontic appliances, teeth bleaching within 12 weeks of screening and use of a chlorhexidine mouthwash currently, or within 14 days of baseline.
-
Participation in another clinical study or receipt of an investigational drug or investigational oral care product within 30 days of Baseline (Visit 2) and previous participation in this study.
-
Recent history (within the last year) of alcohol or other substance abuse.
-
An employee of the sponsor or the study site or members of their immediate family and employed by any dentifrice manufacturer or their immediate family.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Shanghai | China | 200023 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
- Study Director: GSK Clinical Trials, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
Study Documents (Full-Text)
More Information
Publications
None provided.- 207014
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from one center in China. |
|---|---|
| Pre-assignment Detail | A total of 343 participates were screened, out of which 128 participants were randomized in the study. 215 participants were not randomized as 186 participants did not meet study criteria, 5 participants withdrew consent and 24 were not randomized for other reasons (not specified). |
| Arm/Group Title | Test Product | Reference Product |
|---|---|---|
| Arm/Group Description | Participants applied a full strip of dentifrice containing 0.454% weight by weight (w/w) stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 parts per million (ppm) fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. | Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. |
| Period Title: Overall Study | ||
| STARTED | 63 | 65 |
| COMPLETED | 60 | 63 |
| NOT COMPLETED | 3 | 2 |
Baseline Characteristics
| Arm/Group Title | Test Product | Reference Product | Total |
|---|---|---|---|
| Arm/Group Description | Participants applied a full strip of dentifrice containing 0.454% w/w stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 ppm fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. | Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. | Total of all reporting groups |
| Overall Participants | 63 | 65 | 128 |
| Age, Customized (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
40.8
(10.20)
|
42.9
(10.04)
|
41.9
(10.13)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
51
81%
|
52
80%
|
103
80.5%
|
| Male |
12
19%
|
13
20%
|
25
19.5%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
63
100%
|
65
100%
|
128
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Stratification n (%) (Count of Participants) | |||
| Male, Smoker, Baseline MGI <= 2.00 |
0
0%
|
0
0%
|
0
0%
|
| Male, Smoker, Baseline MGI > 2.00 |
1
1.6%
|
1
1.5%
|
2
1.6%
|
| Male, non-smoker, Baseline MGI <= 2.00 |
0
0%
|
0
0%
|
0
0%
|
| Male, non-smoker, Baseline MGI > 2.00 |
11
17.5%
|
12
18.5%
|
23
18%
|
| Female, Smoker, Baseline MGI <= 2.00 |
0
0%
|
0
0%
|
0
0%
|
| Female, Smoker, Baseline MGI > 2.00 |
0
0%
|
0
0%
|
0
0%
|
| Female, non-smoker, Baseline MGI <= 2.00 |
4
6.3%
|
3
4.6%
|
7
5.5%
|
| Female, non-smoker, Baseline MGI > 2.00 |
47
74.6%
|
49
75.4%
|
96
75%
|
Outcome Measures
| Title | Mean Bleeding Index (BI) |
|---|---|
| Description | 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. |
| Time Frame | At Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent to treat (ITT) (n=128) population is defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. |
| Arm/Group Title | Test Product | Reference Product |
|---|---|---|
| Arm/Group Description | Participants applied a full strip of dentifrice containing 0.454% w/w stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 ppm fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. | Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. |
| Measure Participants | 63 | 65 |
| Mean (Standard Deviation) [Score on Scale] |
0.07
(0.059)
|
0.15
(0.128)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Product |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | From ANCOVA with treatment, gender, smoking status and baseline MGI stratification as factors and baseline as covariate. | |
| Method of Estimation | Estimation Parameter | Least square (LS) mean difference |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -0.12 to -0.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference is the first named treatment minus second named treatment such that a negative difference favors the first named treatment. | |
| Title | Number of Bleeding Sites |
|---|---|
| Description | 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. |
| Time Frame | At Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT (n=128) population is defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. |
| Arm/Group Title | Test Product | Reference Product |
|---|---|---|
| Arm/Group Description | Participants applied a full strip of dentifrice containing 0.454% w/w stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 ppm fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. | Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. |
| Measure Participants | 63 | 65 |
| Mean (Standard Deviation) [Number of bleeding sites] |
10.37
(8.499)
|
20.92
(15.881)
|
| Title | Mean Modified Gingival Index (MGI) |
|---|---|
| Description | 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 inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. |
| Time Frame | At Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT (n=128) population is defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. |
| Arm/Group Title | Test Product | Reference Product |
|---|---|---|
| Arm/Group Description | Participants applied a full strip of dentifrice containing 0.454% w/w stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 ppm fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. | Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. |
| Measure Participants | 63 | 65 |
| Mean (Standard Deviation) [Score On Scale] |
1.62
(0.211)
|
1.89
(0.198)
|
| Title | Mean Plaque Index (PI) (Overall and Interproximal) |
|---|---|
| Description | 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 than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.Overall PI score and interproximal PI score were calculated as the mean PI over all tooth sites and mean PI over interproximal sites (distal and mesial) respectively. |
| Time Frame | At Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT (n=128) population is defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. |
| Arm/Group Title | Test Product | Reference Product |
|---|---|---|
| Arm/Group Description | Participants applied a full strip of dentifrice containing 0.454% w/w stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 ppm fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine | Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. |
| Measure Participants | 63 | 65 |
| Mean Plaque Index (PI) (overall) |
1.85
(0.319)
|
2.19
(0.245)
|
| Mean Plaque Index (PI) (interproximal) |
1.92
(0.313)
|
2.24
(0.240)
|
Adverse Events
| Time Frame | 12 Weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Test Product | Reference Product | ||
| Arm/Group Description | Participants applied a full strip of dentifrice containing 0.454% w/w stannous fluoride and 0.0721% w/w sodium fluoride containing 1450 ppm fluoride to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. | Participants applied a full strip of dentifrice containing 0.14% w/w sodium monofluorophosphate (1400 ppm fluoride) to cover the head of the toothbrush provided and brush their teeth with the assigned dentifrice twice daily (morning and evening) for one timed minute following their normal routine. | ||
All Cause Mortality |
||||
| Test Product | Reference Product | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/63 (0%) | 0/65 (0%) | ||
Serious Adverse Events |
||||
| Test Product | Reference Product | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/63 (0%) | 0/65 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Test Product | Reference Product | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/63 (4.8%) | 2/65 (3.1%) | ||
| Gastrointestinal disorders | ||||
| SENSITIVITY OF TEETH | 1/63 (1.6%) | 1 | 0/65 (0%) | 0 |
| STOMATITIS | 1/63 (1.6%) | 1 | 0/65 (0%) | 0 |
| APHTHOUS ULCER | 0/63 (0%) | 0 | 1/65 (1.5%) | 1 |
| Infections and infestations | ||||
| ORAL HERPES | 1/63 (1.6%) | 1 | 0/65 (0%) | 0 |
| NASOPHARYNGITIS | 0/63 (0%) | 0 | 1/65 (1.5%) | 1 |
| PHARYNGITIS | 0/63 (0%) | 0 | 1/65 (1.5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
| GSKClinicalSupportHD@gsk.com |
- 207014