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

A therapeutic equivalence study, comparing two chlorhexidine digluconate formulations, the test formulation Chlorel® Or. T. Sol. 0,2% w / v and the reference formulation Corsodyl® 0.2% w / v Mint Mouthwash. - INTERMED-CHX-SD2X15

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000260-17-GR
Enrollment
Unknown
Registered
2012-08-27
Start date
2012-09-07
Completion date
Unknown
Last updated
2013-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Therapeutic equivalence study, comparing two chlorhexidine digluconate formulations 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: 15.0 Level: LLT Classification code 10063390 Term: Oral hygiene System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 15.0 Level: LLT Classification code 10058078 Term: Tooth plaque System Organ Class: 10017947 - Gas

Interventions

Trade Name: Corsodyl Mint Mouthwash 0.2% w/v Pharmaceutical Form: Oromucosal solution INN or Proposed INN: CHLORHEXIDINE DIGLUCONATE CAS Number: 18472-51-0 Other descriptive name: CHLORHEXIDINE DIGLUC

Sponsors

IOULIA & IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.-INTERMED S.A.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects taking any medication. Subjects with history of allergy to chlorhexidine.

Design outcomes

Primary

MeasureTime frame
Main Objective: The objective of the study is to compare the efficacy and safety of the Test and Reference products both containing 0.2%w/v of chlorhexidine digluconate using specific indices (Plaque Index, Gingival Index, Discoloration Index).;Secondary Objective: N/A;Primary end point(s): No significant difference between the test and reference group for plaque and gingival bleeding and for discoloration at the end of the study. The presence and quantity of plague will be recorded using the plaque index (PI) of Silness and Löe (0-3 rating). In the same surfaces and using the same rating (0-3) the gingival inflammation will be evaluated using the gingival index (GI) of Löe and Silness. Finally the discoloration index of dental tissues will be recorded (DI-Tilliss TSI et al). The index records discoloration both qualitatively (color intensity) and quantitatively (area-amount).;Timepoint(s) of evaluation of this end point: Whole study will be completed within approximately 10 weeks.—

Secondary

MeasureTime frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A—

Countries

Greece

Contacts

Public ContactRegulatory Affairs department

IOULIA & IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.-INTERMED S.A.

intermed@intermed.com.gr00302106253905

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026