Gingival bleeding and gingivitis MedDRA version: 14.1 Level: PT Classification code 10018292 Term: Gingivitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: PT Classification code 10018276 Term: Gingival bleeding System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Corsodyl Mint Mouthwash
Product Name: Corsodyl Mint Mouthwash - alcohol containing
Pharmaceutical Form: Oromucosal solution
CAS Number: 18472-51-0
Other descriptive name: CHLORHEXIDINE DIG
Sponsors
GlaxoSmithKline Consumer Healthcare
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 and not over 64 years. 3. Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions. 4. General Health Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/ dental examination. 5. Dental Health a) Good oral health in the opinion of the investigator (allowing mild to moderate gingivitis to meet entry criteria). b) A minimum of 20 permanent gradable teeth at screening. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded). c) Mild to moderate gingivitis present at the screening visit in the opinion of the investigator. d) Positive response to bleeding on brushing exercise at screening visit. e) A total of 20 bleeding sites or greater at baseline visit. 6. Contraception Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. 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 360 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 pregnant, intending to become pregnant or who have a positive urine pregnancy test at the screening, baseline or prophylaxis visits. 2. Breast-feeding Women who are breast–feeding. 3. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds) or any of their stated ingredients. 4. 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. 5. Medical History/ Current Medications a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity. b) Subjects requiring prophylactic antibiotic treatment prior to dental therapy. c) Use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study or increases the risk to the subject (eg: phenytoin, calcium antagonists, cyclosporine, warfarin, antibiotics, immuno-suppressants). d) Use of antibiotics within two weeks prior to the screening visit or throughout the study. e) Use of any systemic medication which would have an effect on gingival conditions within 14 days of gingival examinations (eg: ibuprofen or aspirin therapy) 6. Dental Health a) Have current active caries b) More than 3 pockets with 5mm or over. c) Excessive calculus present that interferes with the probing examination for Gingival Index. d) Other severe oral/ gingival conditions (e.g. Acute Necrotizing Ulcerative Gingivitis) that may compromise the study or the subjects in the opinion of the investigator or gingivitis examiner. e) Medical conditions which may directly influence gingival bleeding. f) Restorations in a poor state of repair. g) Orthodontic appliances anterior cosmetic restorations and veneers. h) Enamel pitting/irregularities. 7. Tobacco Chewers Subjects using chewing tobacco, pan, pan-masala, gutkha or other chewing tobacco products or subjects who have quit using any of those within the past six months prior to screening. 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 Gingival Bleeding (as assessed by the gingival severity component of the Gingival Index [GI]) following twice daily use of a non-alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only.;Secondary Objective: To evaluate and compare Gingivitis (as assessed by the Gingival Index) following twice daily use of a non-alcohol 0.2% Chlorhexidine (CHX) mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. To evaluate and compare plaque control (overall and interproximal dental plaque scores) using Turesky modification of Quigley & Hein plaque index following twice daily use of a non-alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. ;Primary end point(s): Gingival Severity Index (a component of the Gingival Index assessing the proportion of bleeding sites);Timepoint(s) of evaluation of this end point: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Gingival index score - Overall plaque score (Turesky Modification of the Quigley Hein Index) - Interproximal plaque score (Turesky Modification of the Quigley Hein Index);Timepoint(s) of evaluation of this end point: 6 weeks | — |
Countries
United Kingdom
Contacts
Public ContactGSK CH Clinical Trials
GlaxoSmithKline Consumer Healthcare
Outcome results
None listed