Periodontology
Conditions
Interventions
Trade Name: ZITHROMAX 250mg
Product Name: Azithromycine
Pharmaceutical Form: Capsule
INN or Proposed INN: AZITHROMYCIN
CAS Number: 83905
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient over 35 years of age - Patient with severe chronic periodontitis (loss of attachment = 5mm) generalized (>30% sites) (AAP 1999 classification) and pockets > 5mm on at least 5% of sites - Presence of bleeding on the catheter (= 30%) - Patient with at least 15 teeth including 2 molars (excluding wisdom teeth) - Patient benefiting from a social protection system - Voluntary patient with informed consent 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: - Patient with contraindications to treatment with azithromycin or its excipient: absolute contraindications are the history of allergy to macrolides or to one of the excipients used in this study, combination with ergot derivatives, cisapride, colchicine and severe liver failure (azithromycin being essentially eliminated by the bile ducts). Other contraindications are in patients at risk of cardiac arrhythmias (diagnosis of QT prolongation and/or concomitant treatments, electrolyte disorders (hypokalemia, hypomagnesia, cardiac arrhythmias, heart failure), severe renal failure, and some drug combinations (antivitamin K, statins) - Patient with aggressive periodontitis (AAP 1999 classification) - Patient smoking more than 10 cigarettes/day - Patient at risk of type B infection (endocarditis) or requiring antibiotic prophylaxis, - Patient who has received antibiotic treatment in the 6 months preceding the periodontal examination - Patient who has received anti-inflammatory treatment in the month preceding the periodontal examination and/or anti-inflammatory treatment for more than 3 consecutive days in the 3 months preceding the periodontal examination - Patient on or after drug treatment (cyclosporine and other anti-rejection, anti-epileptic, calcium channel blocker drugs) affecting periodontal status - Patient with pathologies affecting the periodontal state and/or the systemic or local inflammatory response, such as diabetes, infectious or non-infectious stomatitis, inflammatory and autoimmune diseases, immunosuppression - Patient with a prolonged oral hygiene disability (physical/psychic inability to brush teeth) - Patient with a dilapidated oral condition (untreated cavities, unrestated teeth), oral infectious foci whose management requires antibiotic treatment within 6 months - Patient who has had specialized periodontal treatment, curettage/surfacing, or periodontal surgery in the year preceding the examination. - Pregnant woman (controlled by a negative urine beta-HCG test at inclusion) or during breastfeeding - Patient with chronic infections that occur repeatedly (more than 3 times per year) and require antibiotics - Patients who received oral antiseptic treatment in the month prior to the examination - Patient with swallowing disorders - Patient included in another intervention research protocol, or in periods of exclusion (participation in observational research is still possible) - Patient under guardianship and safeguard of justice - Patient with a high risk of bleeding and/or INR>4. - Patient unable to cooperate or understand study and care instructions - Patient under guardianship, curatorship or guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Evaluate the effect of azithromycin on the persistence of pathological periodontal pockets >5mm during non-surgical treatments of severe chronic periodontitis at 3 and 6 months - Evaluate the effect of azithromycin on the evolution of clinical indices, periodontal flora, expression of macrolide resistance genes, and expression of antimicrobial peptides (MAPs) during the treatment of severe chronic periodontitis at 3 and 6 months - Assess compliance and side effects of antibiotic treatment - Evaluate the potential interactions of local clinical, bacterial (periodontal pathogens and resistance genes), and host defense (HDPs) factors with the effect of azithromycin on the proportion of failures of non-surgical treatments of severe chronic periodontitis at 3 and 6 months ;Main Objective: To evaluate the effect of azithromycin on the proportion of failures of non-surgical treatments for severe chronic periodontitis characterized by the persistence of at least one periodontal pocket > 5mm at 6 months.;Primary end point(s): Proportion of subjects showing treatment failure, failure defined by the persistence of at least one residual pocket >5mm at 6 months;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quantitative evolution of supragingival biofilms (Silness and Löe Plate Index) and of 6 main periodontopathogenic bacteria (qPCR) in subgingival biofilms - Evolution of erm(F) gene expression (qPCR) in subgingival biofilms - Evolution of gingival expression of MAPs, alpha-defensin-1, beta-defensin-2 and -3 and cathelicidin LL-37 (RT-qPCR) - Evolution of periodontal pocket depths (mm) at 3 months and 6 months - Evolution of clinical attachment levels (mm) at 3 and 6 months - Evolution of clinical inflammation (Löe and Silness Gingival Index) at 3 and 6 months - Collection of adverse events ;Timepoint(s) of evaluation of this end point: At 3 and 6 months | — |
Countries
France
Contacts
Public ContactErci DEMONSANT
Hôpitaux universitaires de Strasbourg
Outcome results
None listed