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

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ClinicalTrials.gov Identifier: NCT02937636
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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
Gingivitis Other: Stannous fluoride Other: Sodium monofluorophosphate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population.
Actual Study Start Date : September 19, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Mean Bleeding Index [ Time Frame: At 12 Weeks ]
    The Bleeding Index (BI) scoring system will be as follows: 0 = no bleeding after 30 seconds, 1 = bleeding upon probing after 30 seconds, 2 = immediate bleeding observed.


Secondary Outcome Measures :
  1. Number of bleeding sites [ Time Frame: At 12 Weeks ]
    The BI scoring system will be as follows: 0 = no bleeding after 30 seconds, 1 = bleeding upon probing after 30 seconds, 2 = immediate bleeding observed.

  2. Mean Modified Gingival Index [ Time Frame: At 12 Weeks ]
    The Modified Gingival Index (MGI) scoring system will be 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 unit, 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.

  3. Mean Plaque Index (overall and interproximal) [ Time Frame: At 12 Weeks ]
    Plaque Index (PI) will be 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 (1mm or smaller) at the cervical margin of the tooth, 3 = A band of plaque wider than 1mm but covering less than 1/3 of the area, 4 = Plaque covering at least 1/3 but less than 2/3 of the area, 5 = Plaque covering 2/3 or more of the crown of the tooth



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937636


Locations
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China
GSK Investigational Site
Shanghai, China, 200023
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02937636     History of Changes
Other Study ID Numbers: 207014
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fluorides
Tin Fluorides
Fluorophosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs