NCT04198649

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-11-02
• Primary completion: 2023-11-02
• Completion: 2023-11-02
• First posted: 2019-12-13
• Last updated: 2024-08-20

Locations

1 site across 1 country: France