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Completed

NCT Number: NCT06778655

Propolis in Primary Herpetic Gingivostomatitis

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.

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Key information

Conditions

Herpetic Gingivostomatitis DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Mouth Diseases Stomatitis Stomatitis, Herpetic Stomatognathic Diseases Virus Diseases

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

fayoum University

Al Fayyum, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5% propolis gel

Dietary Supplement

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.

Placebo gel

Other

placebo mucoadhesive gel having the same flavor, consistency, and color as the propolis.

Primary outcomes

  1. The severity of oral lesions

    Time frame: one week

    mild, moderate, severe

Secondary outcomes

  1. Pain

    Time frame: one week

    Visual Analogue Scale

  2. measurement of salivary INF-γ level

    Time frame: one week

    by ELISA

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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