Clinical trial NCT06888453: Propolis Lozenges Extract and Their Effect on Salivary Biomarkers and on Oral Health Condition in (19_24) Years Old
Official title: Evaluation the Effects of Propolis Lozenges Extract on Salivary Biomarkers and Its Effect on Oral Health Condition in (19_24) Years Old
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Plaque Induced Gingivitis
Mouth Diseases
Periodontal Diseases
Keywords: gingivitis
plaque
propolis
lozenges
Lead sponsor: Al-Mustansiriyah University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 100
Sex: MALE
Minimum age (years): 19
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the clinical periodontal parameter (Gingival index)
timeFrame: (0, 7days)
Secondary outcomes:
measure: Changes in the clinical periodontal parameter (Plaque index )
timeFrame: (0, 7days)
measure: Changes in salivary cytokines (IL- 1β , IL-10)
timeFrame: (0, 7days)
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Almustansiriyah University
Study officials:
affiliation: Al-Mustansiriyah University
name: ahmed s aljanaby, B.D.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Mustansiriyah University
name: mohammed K Mahmoud, M.S.C
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.