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

NCT05506371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-31

No results posted yet for this study

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.

Conditions

  • Periodontitis

Interventions

DRUG

Az+SRP

Azithromycin as an adjunct to scaling and root planning in the treatment of periodontitis

DRUG

SRP

Scaling and root planning (SRP) treatment of periodontitis

DRUG

No interventions

Diagnostocs to confirm the healthy state of the gingiva

Sponsors & Collaborators

  • Ukrainian Medical Stomatological Academy

    lead OTHER

Principal Investigators

  • Igor P. Kaidashev, MD · Ukrainian Medical Stomatological Academy Poltava, Ukraine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-16
Primary Completion
2019-06-28
Completion
2019-06-28

Countries

  • Ukraine

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 NCT05506371 on ClinicalTrials.gov