Clinical and biological activity of Piascledine® 300 in patients with chronic periodontitis

Active, not recruiting

• Conditions: CHRONIC PERIODONTITIS; MedDRA version: 8.1Level: LLTClassification code 10009102Term: Chronic periodontitis

• Registration Number: EUCTR2005-004457-10-BE
• Lead Sponsor: aboratoires Expanscience

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-14
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Female and male patients, aged 40 to 70 years, suffering from chronic periodontitis with at least 6 teeth bearing a periodontal pocket = 5 mm which bleeds on probing, with at least 13 natural teeth, nonsmokers or having quit smoking for more than a year.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients presenting with the following problems will not be included into the study: aggressive periodontitis, severe immune depression or auto-immune disorder, active or past acute or chronic severe condition of the cardiovascular system, kidneys, liver, gastro-intestinal tract, endocrine system, hematologic system, nervous system, or allergy, judged by the investigator as incompatible with the trial, coagulopathy or anticoagulant treatment, concomitant addiction interfering with the disease, hypersensitivity to Piascledine® or one of its ingredients, antibiotic treatment during the past month, nonsteroidal or steroidal anti-inflammatory treatment during the past month, or periodontal surgical treatment during the previous three months.
Female patients will not be included if they are pregnant, are breast feeding, or are not making use of effective contraception.
Patients will not be included if they have undergone scaling and root planing in the previous three months.

Study & Design

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