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Clinical Trials/EUCTR2015-004306-42-SI
EUCTR2015-004306-42-SIActive, not recruitingPhase 1

Comparison of the efficacy of treatment of chronic periodontitis with scaling and root-planning alone or in combination with azithromycin - a prospective, double blind, randomised clinical trial - Azythromicin as an adjunct for non-surgical treatment of chronic periodontitis

Stomatološka klinika UKC, Ljubljana0 sites40 target enrollmentStarted: December 17, 2015Last updated:
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
40

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • This will include systemically healthy smokers and non-smokers aged between 25 and 65 years, with untreated, moderate to advanced form of chronic periodontitis ( Armitage 1999), which will have at least 16 teeth and at least 12 teeth suitable for the evaluation (not including wisdom teeth, teeth with orthodontic wires , bridges, crowns and implants ) having at least six sites with probing depth > 4 mm, clinical attachemnt loss = 2 mm, and radiographic bone loss.
  • 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 40
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • Excluded will be systemically ill (diabetes, cancer patients, HIV infection, and patients with metabolic bone diseases and diseases that disrupt the processes of wound healing, patients treated with radiation or chemotherapy , immunosuppressants, anti-epileptic drugs, calcium channel blockers, non-steroidal anti-inflammatory drugs, pregnant women and breastfeeding women and patients who have been in the last 12 months treated with antibiotics, allergic or with suspected hypersensitivity to azithromycin , patients who have been in the last year treated due to periodontal disease.

Investigators

Sponsor
Stomatološka klinika UKC, Ljubljana

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