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Clinical Trials/NCT05534334
NCT05534334
Recruiting
Phase 2

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

Beni-Suef University2 sites in 1 country30 target enrollmentStarted: May 1, 2022Last updated:

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
30
Locations
2
Primary Endpoint
Remaining width of the attached gingiva

Overview

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Control arm

Active Comparator

Surgical excision of the gingival pyogenic granuloma

Intervention: Solu-Cortef (Drug)

Intervention

Experimental

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

Intervention: Solu-Cortef (Drug)

Outcomes

Primary Outcomes

Remaining width of the attached gingiva

Time Frame: 6 month

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

Secondary Outcomes

  • Recurrence of the lesion(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eman Magdy Ahmed

Principal Investigator

Beni-Suef University

Study Sites (2)

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