NCT06888453CompletedPhase 1
Propolis Lozenges Extract and Their Effect on Salivary Biomarkers and on Oral Health Condition in (19_24) Years Old
Evaluation the Effects of Propolis Lozenges Extract on Salivary Biomarkers and Its Effect on Oral Health Condition in (19_24) Years Old
Source: ClinicalTrials.gov · Last updated 24 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 5 Mar 2025
- Start date
- 23 Mar 2025
- Primary completion date
- 1 Apr 2025
- Lead sponsor
- Al-Mustansiriyah University
- NCT number
- NCT06888453
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 100
- From 23 Mar 2025 to the primary completion date, 1 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Individuals with chronic illnesses, immunocompromised individuals, pregnant women, those on contraceptive medications, and breastfeeding mothers.
- 2\. People who use mouthwash at the moment or any preventive modalities. 3. Those taking anti-inflammatory drugs and antibiotics both during the study and in the final four weeks prior.
- 4\. Individuals have a history of hypersensitivity to any substance utilized in the current investigation.
- 5\. Individuals who have undergone a recent tooth extraction. 6. Individuals with Periodontal pocket depth Equal or less than 4 or attachment loss.
- 7\. Individuals who smoke. 8. Individuals with orthodontic equipment, removable dentures, implants.
Who the study is looking for
- Age of patients (19\_24) who volunteered to participate.
- Apparently, good general health. With no systemic diseases.
- plaque and gingival indices were ranged from (1.1\_2.0)
Age in the registry: 19 years to 24 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Almustansiriyah University Coordinator of this site? Confirm its status | Baghdad | Iraq | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.