Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes
- Conditions
- Gingival bleeding and gingivitisMedDRA version: 14.1Level: PTClassification code 10018292Term: GingivitisSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 14.1Level: PTClassification code 10018276Term: Gingival bleedingSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
- Registration Number
- EUCTR2012-002236-87-GB
- Lead Sponsor
- GlaxoSmithKline Consumer Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method