Propolis in Primary Herpetic Gingivostomatitis (RCT)

January 28, 2025 updated by: Salsabeel A Afifi, PhD, Fayoum University

Propolis in Management of Primary Herpetic Gingivostomatitis Measuring the Level of INF-γ in Saliva. Randomized Clinical Trial

The purpose of the present study is to investigate the efficacy of 5% propolis gel in the treatment of primary herpetic gingivostomatitis in children and its effect on salivary IFN-γ levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Egypt
      • Fayoum, Egypt
        • Fayoum 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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • clinical manifestations suggestive of PHGS
  • positive culture for HSV-1

Exclusion Criteria:

  • negative culture for HSV-1
  • allergic to honey or its products
  • patients diagnosed with any systemic diseases, immunosuppressed or immunocompromised patients

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Other: Placebo gel
placebo mucoadhesive gel having the same flavor, consistency, and color as the propolis.
Experimental: Propolis group
Dietary supplement: 5% propolis gel
5% propolis gel (prepared according to Joshy et al. 2018) Joshy A, Doggalli N, Patil K, Kulkarni PK. To Evaluate the Efficacy of Topical Propolis in the Management of Symptomatic Oral Lichen Planus: A Randomized Controlled Trial. Contemp Clin Dent. 2018 Jan-Mar;9(1):65-71.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The severity of oral lesions
Time Frame: one week
mild, moderate, severe
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: one week
Visual Analogue Scale
one week
measurement of salivary INF-γ level
Time Frame: one week
by ELISA
one week

Collaborators and Investigators

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

Sponsor

Fayoum University

Investigators

  • Study Director: Rania Shalaby, associate professor, Fayoum University

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)

October 10, 2024

Primary Completion (Actual)

January 15, 2025

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

January 12, 2025

First Submitted That Met QC Criteria

January 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1212025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Herpetic Gingivostomatitis

Clinical Trials on 5% propolis gel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe