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

September 22, 2025 updated by: Ahmed Salah Abdulmahdi Finajn, Al-Mustansiriyah University

Evaluation the Effects of Propolis Lozenges Extract on Salivary Biomarkers and Its Effect on Oral Health Condition in (19_24) Years Old

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

100 subjects will be enrolled, who show generalized gingivitis (moderate gingivitis) with no Periodontal pocket depth>3 mm, intact periodontium, and no loss of periodontal attachment), caused by the accumulation of plaque. 50 subjects are case that given a lozenge containing propolis and oral hygiene instructions, and 50 subjects were control that were given oral hygiene instructions only. The participants will be asked to chew a lozenge twice per day and Discontinuation of the lozenges will be advised in cases of any allergic reaction. in baseline visit at the beginning, Saliva collection for IL-1β and IL-10 measurement, then clinical periodontal parameters examination starting with gingival index (Loe and Silness in 1963) designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency, and bleeding on probing. A periodontal probe will be run along the gingival margin. The gingiva surrounding the tooth is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial papilla and lingual marginal gingiva. Then finally followed by the Plaque Index (Loe and Silness in 1963). the data had been recorded from labial/buccal and lingual/palatal surfaces.

First visit after 7 days, from the baseline visit. Saliva collection and clinical periodontal parameters scoring (GI, PI) will be performed again as described at the baseline visit.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq
        • Almustansiriyah University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age of patients (19_24) who volunteered to participate.
  2. Apparently, good general health. With no systemic diseases.
  3. plaque and gingival indices were ranged from (1.1_2.0)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Other Names:
  • bee glue
No Intervention: standard of care
Participants will be instructed to ordinary oral hygiene instruction only, No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the clinical periodontal parameter (Gingival index)
Time Frame: (0, 7days)

Subjects will undergo the measurement of the gingival index according to (Loe & Silness in 1963), designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency, and bleeding on probing. The Gingival Index (GI) scores each site on a 0 to 3 scale

Score 0 : Normal gingiva

score 1: Mild Inflammation- slight change in color, Slight oedema. No bleeding on probing.

score 2: Moderate inflammation-redness, oedema and glazing. Bleeding on probing.

score 3: Sever inflammation-marked redness and edema. Ulceration. Tendency to spontaneous bleeding.
(0, 7days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the clinical periodontal parameter (Plaque index )
Time Frame: (0, 7days)

To determine the patients' plaque index, their dental plaque thickness was evaluated by probing the mesial, distal, buccal, and palatal surfaces of all teeth using a Williams periodontal probe. The individual's plaque index was determined by summing the values obtained for each tooth and calculating the averages.Silness & Löe (Silness & Löe,1964) reference values were taken as a basis The Plaque Index (PI) scores each site on a 0 to 3 scale

Score 0 : No plaque is in the area adjacent to the gingiva.

Score 1: There is a plaque in the form of a thin film on the gingival margin.

Score 2: There is a visible plaque in the gingival pocket and gingival margin.

Score 3: There is a dense plaque in the gingival pocket and on the gingival margin.
(0, 7days)
Changes in salivary cytokines (IL- 1β , IL-10)
Time Frame: (0, 7days)

ELISA kit will analyze salivary interleukins, and concentrations are measured according to manufacturing instructions, were picogram per liter for interleukin 1 beta levels and nanogram per milliliter for interleukin 10 levels

0 day: Saliva collection for IL-1β and IL-10 measurement, then clinical periodontal parameters examination starting with the gingival index finally followed by the Plaque index

7 days: Saliva collection and clinical periodontal parameters scoring (GI, PI) will be performed again as described at the baseline visit,
(0, 7days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Mustansiriyah University

Investigators

  • Principal Investigator: ahmed s aljanaby, B.D.S, Al-Mustansiriyah University
  • Study Director: mohammed K Mahmoud, M.S.C, Al-Mustansiriyah University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2025

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

April 20, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 15, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL-Mustansiriyah University

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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