NCT05534334

Brief Summary

Gingival Pyogenic granuloma in the esthetic zone represents an esthetic problem. While surgical treatment may not give the premium esthetic demands, corticosteroid may acheive this balance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

September 6, 2022

Last Update Submit

September 12, 2022

Conditions

Oral Pyogenic Granuloma

Outcome Measures

Primary Outcomes (1)

  • Remaining width of the attached gingiva

    Remaining width of the attached gingival it is measured using graduated probe

    6 month

Secondary Outcomes (1)

  • Recurrence of the lesion

    6 months

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Surgical excision of the gingival pyogenic granuloma

Drug: Solu-Cortef

Intervention

EXPERIMENTAL

Intralesional injection with corticosteroids solution (1.8 mL of 100 mg hydrocortisone)

Drug: Solu-Cortef

Interventions

Solu-CortefDRUG

A vial sol. used for intra-mascular injection

Also known as: Hydrocortisone
Control armIntervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with oral pyogenic granuloma at the esthetic zone

You may not qualify if:

  • Patients who were not compliant to oral hygiene instructions and can not be motivated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beni_Suef University

Banī Suwayf, Beni Suweif Governorate, 1172, Egypt

RECRUITING

Eman Ahmed

Banī Suwayf, Benisuef, 1178, Egypt

RECRUITING

MeSH Terms

Interventions

hydrocortisone hemisuccinateHydrocortisone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Eman Magdy, PhD

    Lecturer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Magdy, PhD

CONTACT

01001077882emysanfora82@yahoo.com

Eman Magdy, PhD

CONTACT

01142131053dentistsherif@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 9, 2022

Study Start

May 1, 2022

Primary Completion

November 29, 2022

Study Completion

November 29, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)