Gingivitis MedDRA version: 12.0 Level: LLT Classification code 10018292 Term: Gingivitis
Conditions
Interventions
Product Name: GSK Experimental Dentifrice MFC02753
Product Code: GSK Experimental Dentifrice MFC02753
Pharmaceutical Form: Toothpaste
INN or Proposed INN: Sodium Fluoride
CAS Number: 7681-49-4
Other d
Sponsors
GlaxoSmithKline Consumer Healthcare (GSKCH)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Consent Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 2. Age Aged at least 18 years. 3. Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions. 4. General Health Good general health in the opinion of the investigator, with no clinically significant and relevant abnormalities of medical history or physical examination. 5. Dental Health a) A minimum of 20 permanent gradable teeth. A scorable surface is defined as a surface that has 50% of the surface gradable. Third molars, orthodontically banded/ bonded, fully crowned or extensively restored, grossly carious or abutment teeth are not included in the tooth count. b) Mild to moderate gingivitis present at the screening visit in the opinion of the investigator. c) MGI between 1.50 and 2.30 at Pre-Prophy Baseline and Randomisation visit. d) Reduction in MGI between Pre-Prophy Baseline and Randomisation visit. e) All teeth required for plaque sampling are present (for sub-set of subjects undergoing plaque sampling only). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. 2. Breast-feeding Women who are breast–feeding. 3. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 4. Dental Health a) Have current active caries or periodontitis that may compromise the study or the health of the subjects in the opinion of the investigator or MGI examiner. b) Restorations in a poor state of repair. c) Partial dentures or orthodontic appliances. 5. Smokers Current smokers or smokers who have quit within the past 6 months prior to screening. 6. Medication a) Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to gingival health examinations. b) Use of any systemic medication which would have an effect on gingival conditions within 14 days of gingival health examinations (e.g. calcium channel blockers, ibuprofen or aspirin therapy). 7. Clinical Study/Experimental Medication a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. b) Previous participation in this study. 8. Substance abuse Recent history (within the last year) of alcohol or other substance abuse. 9. Personnel a) An employee of the sponsor or the study site or members or their immediate family. b) An employee of any toothpaste manufacturer or their immediate family.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare gingivitis as measured by Modified Gingival Index (MGI) and Bleeding Index (BI) following twice daily use of an experimental toothpaste compared to a reference toothpaste after 12 weeks;Secondary Objective: To evaluate and compare gingivitis as measured by MGI and BI following twice daily use of experimental toothpaste compared to reference toothpaste after 4 and 8 weeks. To evaluate and compare dental plaque scores (overall and interproximal) following twice daily use of experimental toothpaste compared to reference toothpaste after 4, 8 and 12 weeks. To evaluate and compare changes in cultivable plaque bacterial groups in plaque samples, following twice daily use of experimental toothpaste compared to reference toothpaste after 4 and 12 weeks ;Primary end point(s): Modified Gingival Index | — |
Countries
United Kingdom
Outcome results
None listed