Number of remaining deep pockets after treatment of patients with chornic periodontitis MedDRA version: 18.1 Level: PT Classification code 10060945 Term: Bacterial infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Azibiot
Product Name: Azibiot
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AZITHROMYCIN
Other descriptive name: AZITHROMYCIN DIHYDRATE
Concentration unit: mg milligram(s)
Sponsors
Stomatološka klinika UKC, Ljubljana
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if the number of diseased sites in patients with advanced chronic periodontitis will be different after adjunctive use of azithromycin in comprisson to mechanical debridement alone;Secondary Objective: To determine if the treatment result is dependent on the presence of the most relevant periodontal pathogens (e. g. Aggregibacter actinomycetemcomitans);Primary end point(s): To evaluate if the number of diseased sites in patients with advanced chronic periodontitis will be different after adjunctive use of azithromycin in comprisson to mechanical debridement alone;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine if the treatment result is dependent on the presence of the most relevant pariodontal pathogens (e. g. Aggregibacter actinomycetemcomitans);Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Slovenia
Contacts
Public ContactCLinical Trials INformations
Stomatološka klinika UKC, Ljubljana
Outcome results
None listed