A clinical study, comparing the efficacy of two mouthwashes containingchlorhexidine digluconate - the test formulation Chlorel® Or. T. Sol. 0,2% w / v and the reference formulation Corsodyl® 0.2% w / v Mint Mouthwash.

• Conditions: Therapeutic equivalence study, comparing two chlorhexidine digluconateformulations indicated for inhibition of the formation of dental plaque, as an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene.; MedDRA version: 15.0Level: LLTClassification code 10063390Term: Oral hygieneSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 15.0Level: LLTClassification code 10058078Term: Tooth plaqueSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 15.0Level: LLTClassification code 10018294Term: Gingivitis infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2012-000260-17-GR
• Lead Sponsor: IOULIA & IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.-INTERMED S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-27
• Last Update Posted: 22 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

?ealthy male and female volunteers, at least 18 years of age, students of the School of Dentistry of the University of Athens, non-smokers, with high level of oral hygiene(CPITN <2), with no active dental caries and with no removable dental prostheses or fixed or removable orthodontic appliances.
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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects taking any medication.
Subjects with history of allergy to chlorhexidine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified