drugset / Trial / NCT06888453

Propolis Lozenges Extract and Their Effect on Salivary Biomarkers and on Oral Health Condition in (19_24) Years Old

NCT06888453 ↗

Phase 1 Completed 100 enrolled Al-Mustansiriyah University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to test the efficiency of using lozenges containing propolis extract over one week to control gingival inflammation and plaque accumulation by measuring the clinical periodontal parameters (Gingival index, plaque index) in comparison with a control group given oral hygiene instruction only in patients with biofilm induced gingivitis (moderate gingivitis) Objectives: 1. Evaluate the clinical efficiency of using lozenges containing propolis extract over 7 days to control gingival inflammation and plaque accumulation by measuring the clinical periodontal parameters (Gingival index, plaque index) in comparison with a control group given oral hygiene instruction only in patients with biofilm induced gingivitis (moderate gingivitis). 2. Measuring levels of salivary cytokines, IL-1Beta, and IL-10 by ELISA at Baseline visit before using lozenges containing propolis and after 7 days of using lozenges containing propolis compared to a control group with oral hygiene instruction only. 3. Investigate and compare the association of salivary interleukins of IL-Beta and IL-10 in periodontal health and generalized gingivitis. 4. Evaluate the correlation between clinical periodontal parameters and salivary (IL-1Beta and IL-10). 5. Evaluate subjects' perception of lozenges containing propolis extract and oral hygiene instructions after 7 days.

Timeline

Start
2025-03-23
Primary completion
2025-04-01
Completion
2025-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject lozenges containing propolis Unknown — Oral

Indications