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

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

Study Overview

• Status: Terminated
• Conditions: Severe Chronic Periodontitis
• Intervention / Treatment: Drug: Non-surgical periodontal treatment and azithromycin treatment; Other: Non-surgical periodontal treatment and placebo treatment

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • Les Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Azithromycin; 62 patients Non-surgical periodontal treatment and two 250mg azithromycin tablets one time daily for 3 days	Drug: 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
Placebo Comparator: Placebo; 62 patients Non-surgical periodontal treatment and two 250mg starch tablets one time daily for 3 days	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with failure of treatment, failure defined by persistence of at least one residual periodontal pocket > 5mm	At 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): November 2, 2023
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Chronic Disease; Periodontitis; Chronic Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: 6996 (Other Identifier: Pennsylvania State University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No