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Clinical Trials/EUCTR2015-004306-42-SI
EUCTR2015-004306-42-SI
Active, not recruiting
Phase 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 enrollmentDecember 17, 2015
DrugsAzibiot

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Stomatološka klinika UKC, Ljubljana
Enrollment
40
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 17, 2015
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Stomatološka klinika UKC, Ljubljana

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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