Effects of Azithromycin as an Adjunct to Scaling and Root Planning in the Treatment of Periodontitis

• Status: Completed
• Trial end date: 2019-06-28
• Target enrollment: 0
• Participant gender: All

Summary

The growing interest in the possibilities of modulating macrophages in inflammatory diseases with therapeutic purpose has prompted the development of new approaches for the treatment of periodontitis.

This randomized add-on open clinical study evaluated the short-term effects of azithromycin (Az) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis.

The investigators measured periodontal parameters, and collected gingival biopsies from patients with periodontitis (P group, n=50) before and 1 month after scaling and root planning (SRP group, n=25), after scaling and root planning with oral azithromycin administration (Az group, n=25), and from periodontally healthy individuals (H group, n=25). The last served as a reference group. Macrophage subpopulations were identified through immunohistochemistry as single positive CD68+ and CD163+ cells. The levels of M1-, and M2-related cytokines (IL1-β, IL-6, IL-10, TGF-β) assay in the tissue culture medium was provided by ELISA. The data were statistically analyzed by appropriate methods.

The null hypothesis tested was that L-arginine and L-ornithine have no influences on CD68+ and CD163+ Mφs densities.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ukrainian Medical Stomatological Academy

Criteria

Inclusion criteria for healthy volunteers:

• Presence of more than 20 teeth (for each tooth, the probing pocket depth ≤3 mm

• Absence of clinical gingival inflammation at intact or reduced periodontium

Inclusion Criteria:

• The presence of at least 15 natural teeth, at least 10 sites with the periodontal pocket depth (PPD) ≥4 mm, and/or clinical attachment loss of ≥4 mm at the same site, and satisfactory general health

Exclusion Criteria:

• Taking antibiotics or anti-inflammatory medications within the previous 3 months

• Periodontal therapy within the previous 6 months

• Purulent exudation from periodontal pockets

• Pregnancy or breastfeeding

• Severe, uncontrolled (decompensated) diseases of the internal organs, or neuropsychiatric disorders

• Other conditions that determined the patient's inability to understand the nature and possible consequences of the study