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

NCT04198649 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-08-20

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2023-11-02
Completion
2023-11-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198649 on ClinicalTrials.gov