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

NCT06888453 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-24

No results posted yet for this study

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.

Conditions

  • Plaque Induced Gingivitis
  • Mouth Diseases
  • Periodontal Diseases

Interventions

DRUG

lozenges containing propolis

lozenges containing propolis Participants will be given the test interventions, lozenges containing propolis, and will be asked to chew twice per day and will be instructed to ordinary oral hygiene instruction, No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days

Sponsors & Collaborators

  • Al-Mustansiriyah University

    lead OTHER

Principal Investigators

  • ahmed s aljanaby, B.D.S · Al-Mustansiriyah University

  • mohammed K Mahmoud, M.S.C · Al-Mustansiriyah University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
24 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Iraq

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 NCT06888453 on ClinicalTrials.gov