GingivitisNCT02937636
To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population
A study testing Stannous fluoride and Sodium monofluorophosphate in people with Gingivitis, run by GlaxoSmithKline at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Stannous fluoride and Sodium monofluorophosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2017to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population.
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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- Stannous fluoride, Sodium monofluorophosphate
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous fluorideOther
Experimental dentifrice containing 0.454% w/w stannous fluoride \& 0.0721% w/w sodium fluoride containing1450 parts per million (ppm) fluoride
Sodium monofluorophosphateOther
Dentifrice containing 0.14% w/w sodium monofluorophosphate containing1400 ppm fluoride
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | 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. Receives: Other: Stannous fluoride |
| Reference Product | Active comparator | 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. Receives: Other: Sodium monofluorophosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Bleeding Index (BI)
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.
Measured: At Week 12
Secondary outcomes (3)
Number of Bleeding Sites
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.
Measured: At Week 12
Mean Modified Gingival Index (MGI)
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.
Measured: At Week 12
Mean Plaque Index (PI) (Overall and Interproximal)
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.
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start19 Sep 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937636
- Sponsor's protocol ID
- 207014
- Status last verified
- Mar 2019
- First submitted
- 17 Oct 2016
- Last updated
- 14 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population.
- ClinicalTrials.gov ID
- NCT02937636
- Acronym / sponsor ID
- 207014
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 14 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Other: Stannous fluorideParticipants 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. |
| Reference Product | Active comparator | Other: Sodium monofluorophosphateParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stannous fluorideExperimental dentifrice containing 0.454% w/w stannous fluoride \& 0.0721% w/w sodium fluoride containing1450 parts per million (ppm) fluoride | Other | Test Product |
| Sodium monofluorophosphateDentifrice containing 0.14% w/w sodium monofluorophosphate containing1400 ppm fluoride | Other | Reference Product |
Primary outcome
Mean Bleeding Index (BI)
Time frame: 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.
3 secondary outcomes
Number of Bleeding Sites
Time frame: At Week 12
Mean Modified Gingival Index (MGI)
Time frame: At Week 12
Mean Plaque Index (PI) (Overall and Interproximal)
Time frame: At Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stannous fluoride and Sodium monofluorophosphate in people with Gingivitis, run by GlaxoSmithKline at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Bleeding Index (BI) (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.