EUCTR2012-002236-87-GB
Active, not recruiting
Not Applicable
Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes
GlaxoSmithKline Consumer Healthcare0 sitesJune 7, 2012
ConditionsGingival 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]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gingival bleeding and gingivitis
- Sponsor
- GlaxoSmithKline Consumer Healthcare
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
- •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).
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
Outcomes
Primary Outcomes
Not specified
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