Propolis in Primary Herpetic Gingivostomatitis | NCT06778655

Studies
Propolis in Primary Herpetic Gingivostomatitis

NCT06778655

Sponsor

Fayoum University

Status

Completed

Last Update Posted

Jan 30, 2025Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Herpetic Gingivostomatitis

Interventions

5% propolis gel
Placebo gel

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2024Actual

Primary Completion Date

Jan 15, 2025Actual

Completion Date

Jan 15, 2025Actual

First Submitted Date

Jan 12, 2025

First Submission Date that Met QC Criteria

Jan 12, 2025

First Posted Date

Jan 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2025

Last Update Posted Date

Jan 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Salsabeel A Afifi, PhD, lecturer of oral medicine and periodontology, Fayoum UniversityPrincipal Investigator

Lead Sponsor

Fayoum UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propolis group	Experimental		Dietary Supplement: 5% propolis gel
Control group	Placebo Comparator		Other: Placebo gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rania Shalaby, associate professor	Fayoum University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
fayoum University		Al Fayyum			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

upon request

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013283	Stomatitis, Herpetic

Ancestor Terms

ID	Term
D006561	Herpes Simplex
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided