NCT06778655

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 12, 2025

Last Update Submit

January 28, 2025

Conditions

Herpetic Gingivostomatitis

Outcome Measures

Primary Outcomes (1)

  • The severity of oral lesions

    mild, moderate, severe

    one week

Secondary Outcomes (2)

  • Pain

    one week

  • measurement of salivary INF-γ level

    one week

Study Arms (2)

Propolis group

EXPERIMENTAL
Dietary Supplement: 5% propolis gel

Control group

PLACEBO COMPARATOR
Other: Placebo gel

Interventions

5% propolis gelDIETARY_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.

Propolis group
Placebo gelOTHER

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

Control group

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Stomatitis, Herpetic

Condition Hierarchy (Ancestors)

Herpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsStomatitisMouth DiseasesStomatognathic Diseases

Study Officials

  • Rania Shalaby, associate professor

    Fayoum University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral medicine and periodontology

Study Record Dates

First Submitted

January 12, 2025

First Posted

January 16, 2025

Study Start

October 10, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

upon request

Shared Documents
STUDY PROTOCOL, SAP

Locations

EG(1)