Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone.

NCT ID: NCT05534334

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-11-29

Brief Summary

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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.

Detailed Description

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In our practice, the investigators have found the use of topical steroids effectively induced regression of PGs. This protocol has been suggested by published case reports supported by the anti-inflammatory actions corticosteroid.

This is a particularly valuable approach for patients who have PG in the esthetic zone allowing the surgeon to keep maximum amount of periodontal tissues.

Conditions

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Oral Pyogenic Granuloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control arm

Surgical excision of the gingival pyogenic granuloma

Group Type ACTIVE_COMPARATOR

Solu-Cortef

Intervention Type DRUG

A vial sol. used for intra-mascular injection

Intervention

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

Group Type EXPERIMENTAL

Solu-Cortef

Intervention Type DRUG

A vial sol. used for intra-mascular injection

Interventions

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Solu-Cortef

A vial sol. used for intra-mascular injection

Intervention Type DRUG

Other Intervention Names

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Hydrocortisone

Eligibility Criteria

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Inclusion Criteria

* Patients with oral pyogenic granuloma at the esthetic zone

Exclusion Criteria

* Patients who were not compliant to oral hygiene instructions and can not be motivated
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Eman Magdy Ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Magdy, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

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Beni_Suef University

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status RECRUITING

Eman Ahmed

Banī Suwayf, Benisuef, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman Magdy, PhD

Role: CONTACT

01001077882

Eman Magdy, PhD

Role: CONTACT

01142131053

Facility Contacts

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Eman Magsy, Lecturer

Role: primary

01001077882

Eman Ahmed, PhD

Role: primary

01001077882

Other Identifiers

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17/4/21

Identifier Type: -

Identifier Source: org_study_id

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