Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment

NCT ID: NCT04198649

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2023-11-02

Brief Summary

Primary purpose: Evaluate the effect of azithromycin on failure proportion of severe chronic periodontitis non-surgical treatment; failure characterized by the persistence of at least one periodontal pocket> 5mm at 6 months

Secondary purpose:

• Evaluate the effect of azithromycin on the persistence of pathological periodontal pockets > 5mm during non-surgical treatment of severe chronic periodontitis at 3 months and 6 months
• Evaluate the effect of azithromycin on the changes of clinical signs, periopathogen levels, expression of macrolides resistance genes, and expression of antimicrobial peptides (PAMs) during treatment of severe chronic periodontitis at 3 months and 6 months
• Assess therapeutic observance and side effects of antibiotic treatment
• Assess at 3 and 6 months the potential interactions of local, bacterial (periopathogen and resistance gene) clinical factors, and host defense (PAMs) with the effect of azithromycin, on failure proportion of severe chronic periodontitis non-surgical treatment

Conditions

Severe Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Azithromycin

62 patients Non-surgical periodontal treatment and two 250mg azithromycin tablets one time daily for 3 days

Group Type: EXPERIMENTAL

Non-surgical periodontal treatment and azithromycin treatment

Intervention Type: DRUG

Procedure: periodontal treatment: oral hygiene instruction, scaling and root planning Drug: two 250mg azithromycin tablets one time daily for 3 days after scaling and root planning sessions

Placebo

62 patients Non-surgical periodontal treatment and two 250mg starch tablets one time daily for 3 days

Group Type: PLACEBO_COMPARATOR

Non-surgical periodontal treatment and placebo treatment

Intervention Type: OTHER

Procedure: periodontal treatment: oral hygiene instruction, scaling and root planning Placebo: two 250mg starch tablets one time daily for 3 days after scaling and root planning sessions

Interventions

Non-surgical periodontal treatment and azithromycin treatment

Procedure: periodontal treatment: oral hygiene instruction, scaling and root planning Drug: two 250mg azithromycin tablets one time daily for 3 days after scaling and root planning sessions

Intervention Type: DRUG

Non-surgical periodontal treatment and placebo treatment

Procedure: periodontal treatment: oral hygiene instruction, scaling and root planning Placebo: two 250mg starch tablets one time daily for 3 days after scaling and root planning sessions

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient with severe generalized chronic periodontitis (loss of attachment ≥ 5mm at > 30% sites) (AAP classification 1999) and periodontal pockets >5mm on at least 5% of sites
• presence of bleeding on probing (≥ 30%)
• male or female subject older than 35 Years
• patient with at least 15 teeth including at least 2 molars (excluding wisdom teeth)
• patient with social assurance
• voluntary patient who signed informed consent

Exclusion Criteria

• Patient with contraindications to treatment with azithromycin or its excipient: absolute contraindications are the history of allergy to macrolides or one of the excipients used in this study, association with ergot derivatives Rye, Cisapride, colchicine, and severe hepatic deficiencies. Other contraindications are for patients at risk of cardiac arrhythmia (diagnosis of QT interval prolongation and/or concomitant treatments, electrolytic disorder (hypokalemia, hypomagnesemia, cardiac arrhythmia, heart failure), severe renal failure, and drug associations (Antivitamin K, statins)
• Patient with aggressive periodontitis (AAP classification 1999)
• Patient smoking more than 10 cigarettes/day
• Patient with endocarditis risk or requiring antibiotic prophylaxis
• Patient with antibiotic treatment within 6 months prior to periodontal examination
• Patient with anti-inflammatory treatment in the month preceding periodontal examination and/or anti-inflammatory treatment of more than 3 consecutive days in the 3 months preceding periodontal examination
• Patient following or having followed a drug treatment (cyclosporine and other anti-rejection drugs, antiepileptic, calcium inhibitor) influencing periodontal status
• Patient with pathologies influencing periodontal status and/or systemic or local inflammatory response, such as diabetes, infectious stomatitis or not, diseases inflammatory and autoimmune, immuno-depression
• Patient with prolonged oral hygiene disability (physical/psychic impossibility of brushing teeth)
• Patient with impaired oral condition (untreated cavities, non-dental teeth rehabilitated), dental infections whose management requires antibiotic treatment within 6 months
• Patient having specialized periodontal treatment, root planning, or a periodontal surgical treatment in the year prior to the examination
• Pregnant woman or breastfeeding
• Patient with repeated chronic infections (more than 3 times per year) requiring antibiotic treatment
• Patient who had oral antiseptic treatment in the previous month
• Patient included in another intervention research protocol or in periods of exclusion (participation in an observational study remains possible)
• Patient with high bleeding risk and/or INR > 4.
• Patient under guardianship and under protection of justice
• Patient unable to cooperate or understand the instructions related to the study and care

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

6996

Identifier Type: -

Identifier Source: org_study_id