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

Phase 1

• Conditions: umber of remaining deep pockets after treatment of patients with chornic periodontitis; MedDRA version: 18.1Level: PTClassification code 10060945Term: Bacterial infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

• Registration Number: EUCTR2015-004306-42-SI
• Lead Sponsor: Stomatološka klinika UKC, Ljubljana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-17
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

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