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Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

NCT04198649•University Hospital, Strasbourg, France

View on ClinicalTrials.gov

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

Eligibility

Age

35 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Key Dates

Start Date

November 2, 2021

Primary Completion Date

November 2, 2023

Completion Date

November 2, 2023

Last Updated

August 20, 2024

Enrollment

ACTUAL participants

Conditions

Severe Chronic Periodontitis

Interventions

Non-surgical periodontal treatment and azithromycin treatment

DRUG

Non-surgical periodontal treatment and placebo treatment

OTHER

Treatment of Periodontitis With Er:YAG Laser

NCT03628872

Generalized Moderate Chronic PeriodontitisGeneralized Severe Chronic Periodontitis+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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