Herpetic GingivostomatitisRCTNCT06778655

Propolis in Primary Herpetic Gingivostomatitis

A study testing 5% propolis gel in people with Herpetic Gingivostomatitis, run by Fayoum University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 3 to 8 years
Conditions the study is for: Herpetic Gingivostomatitis
What is being tested?: 5% propolis gel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 10 Oct 2024to 15 Jan 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

clinical manifestations suggestive of PHGS
positive culture for HSV-1

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

fayoum University
Al Fayyum

Other trials in Egypt

About this study

Official title: 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.

Conditions: Herpetic Gingivostomatitis
Being tested: 5% propolis gel, Placebo gel
Medical subject headings: Stomatitis, Herpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06778655
Study group	Role	What they receive
Propolis group	Experimental	Not described Receives: Dietary Supplement: 5% propolis gel
Control group	Placebo comparator	Not described Receives: Other: Placebo gel

What is being measured

The primary outcome is the main question the study is designed to answer.

The severity of oral lesions
mild, moderate, severe
Measured: one week

Secondary outcomes (2)

Pain
Visual Analogue Scale
Measured: one week
measurement of salivary INF-γ level
by ELISA
Measured: one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 202415 Jan 2025

First posted16 Jan 2025
Study start10 Oct 2024
Primary completion15 Jan 2025
Study completion15 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Herpetic GingivostomatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06778655
Sponsor's protocol ID: 1212025
Acronym: RCT
Status last verified: Jan 2025
First submitted: 12 Jan 2025
Last updated: 30 Jan 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: upon request

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Propolis in Management of Primary Herpetic Gingivostomatitis Measuring the Level of INF-γ in Saliva. Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06778655
Acronym / sponsor ID: RCT / 1212025
Conditions: Herpetic Gingivostomatitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Fayoum UniversityUniversity, hospital or other
Study start: 10 Oct 2024 (actual)
Primary completion: 15 Jan 2025 (actual)
Study completion: 15 Jan 2025 (actual)
First posted: 16 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Propolis group	Experimental	Dietary Supplement: 5% propolis gel
Control group	Placebo comparator	Other: Placebo gel

Who may qualify

Ages: 3 to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

clinical manifestations suggestive of PHGS
positive culture for HSV-1

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
5% propolis gel5% 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.	Dietary supplement	Propolis group
Placebo gelplacebo mucoadhesive gel having the same flavor, consistency, and color as the propolis.	Other	Control group

Primary outcome

The severity of oral lesions
Time frame: one week
mild, moderate, severe

2 secondary outcomes

Pain
Time frame: one week
measurement of salivary INF-γ level
Time frame: one week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
Individual participant dataSharing planned: Yes. upon request

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rania Shalaby, associate professor study director

Fayoum University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 5% propolis gel in people with Herpetic Gingivostomatitis, run by Fayoum University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The severity of oral lesions (time frame: one week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06778655.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.