CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Az+SRP +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05506371
NCT05506371N/ACompleted

Azithromycin as an Adjunct to Scaling and Root Planning Causes an Increase of CD68+, CD163+ Macrophages Density in the Gingival Tissues of Periodontitis Patients: a Randomized Controlled Short-term Clinical Trial

Ukrainian Medical Stomatological Academy·interventional·Posted Aug 18, 2022·Updated Oct 31, 2023

In Brief

A clinical study evaluating Az+SRP, SRP, and 1 other intervention for Periodontitis. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeriodontitis
CountriesUkraine
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 18, 2022
Enrollment StartSep 16, 2017
Primary CompletionJun 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.9 years ago

Interventions

Az+SRPdrug

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

SRPdrug

Scaling and root planning (SRP) treatment of periodontitis

No interventionsdrug

Diagnostocs to confirm the healthy state of the gingiva