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

NCT06888453 | Completed Phase 1

• 1 other identifier: AL-Mustansiriyah University
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.Investigate and compare the association of salivary interleukins of IL-Beta and IL-10 in periodontal health and generalized gingivitis.
4. 4.Evaluate the correlation between clinical periodontal parameters and salivary (IL-1Beta and IL-10).
5. 5.Evaluate subjects' perception of lozenges containing propolis extract and oral hygiene instructions after 7 days.

Conditions

Plaque Induced Gingivitis; Mouth Diseases; Periodontal Diseases

Keywords

gingivitis; plaque; propolis; lozenges

Outcome Measures

Primary Outcomes (1)

• Changes in the clinical periodontal parameter (Gingival index)

  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 Outcomes (2)

• Changes in the clinical periodontal parameter (Plaque index )

  (0, 7days)

• Changes in salivary cytokines (IL- 1β , IL-10)

  (0, 7days)

Study Arms (2)

lozenges containing propolis

EXPERIMENTAL

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

standard of care

NO INTERVENTION

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.

Interventions

lozenges containing propolis DRUG

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

Also known as: bee glue

lozenges containing propolis

Eligibility Criteria

• Age: 19 Years - 24 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• \. Individuals with chronic illnesses, immunocompromised individuals, pregnant women, those on contraceptive medications, and breastfeeding mothers.
• \. 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.
• \. Individuals have a history of hypersensitivity to any substance utilized in the current investigation.
• \. Individuals who have undergone a recent tooth extraction. 6. Individuals with Periodontal pocket depth Equal or less than 4 or attachment loss.
• \. Individuals who smoke. 8. Individuals with orthodontic equipment, removable dentures, implants.

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Almustansiriyah University

Baghdad, Iraq

Location

Related Publications (3)

• Shi H, Yang H, Zhang X, Yu LL. Identification and quantification of phytochemical composition and anti-inflammatory and radical scavenging properties of methanolic extracts of Chinese propolis. J Agric Food Chem. 2012 Dec 19;60(50):12403-10. doi: 10.1021/jf3042775. Epub 2012 Dec 5.

  PMID: 23176258 BACKGROUND

• El-Allaky HS, Wahba NA, Talaat DM, Zakaria AS. Antimicrobial Effect of Propolis Administered through Two Different Vehicles in High Caries Risk Children: A Randomized Clinical Trial. J Clin Pediatr Dent. 2020 Sep 1;44(5):289-295. doi: 10.17796/1053-4625-44.5.1.

  PMID: 33181849 BACKGROUND

• Alghutaimel H, Matoug-Elwerfelli M, Alhaji M, Albawardi F, Nagendrababu V, Dummer PMH. Propolis Use in Dentistry: A Narrative Review of Its Preventive and Therapeutic Applications. Int Dent J. 2024 Jun;74(3):365-386. doi: 10.1016/j.identj.2024.01.018. Epub 2024 Feb 19.

  PMID: 38378400 BACKGROUND

MeSH Terms

Conditions

Mouth Diseases; Periodontal Diseases; Gingivitis; Plaque, Amyloid

Interventions

Propolis

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Infections; Gingival Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• ahmed s aljanaby, B.D.S

  Al-Mustansiriyah University

  PRINCIPAL INVESTIGATOR

• mohammed K Mahmoud, M.S.C

  Al-Mustansiriyah University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master student

Model Details: 100 subjects with plaque induced gingivitis, caused by accumulation of plaque, will be selected and enrolled in this study. Subsequently, subjects will be equally divided case and control groups

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 21, 2025
• Study Start: March 23, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 20, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

IR (1)