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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Pyogenic Granuloma
• Intervention / Treatment: Drug: Solu-Cortef

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Eman Magdy, PhD; Phone Number: 01001077882; Email: emysanfora82@yahoo.com
• Study Contact Backup: Name: Eman Magdy, PhD; Phone Number: 01142131053; Email: dentistsherif@gmail.com

Study Locations

• Egypt
  • Bani Suwayf
    • Banī Suwayf, Bani Suwayf, Egypt, 1172
      • Recruiting
      • Beni_Suef University
      • Contact: Eman Magsy, Lecturer; Phone Number: 01001077882; Email: emanmagdy@dent.bsu.edu.eg
  • Benisuef
    • Banī Suwayf, Benisuef, Egypt, 1178
      • Recruiting
      • Eman Ahmed
      • Contact: Eman Ahmed, PhD; Phone Number: 01001077882; Email: emanmagdy@dent.bsu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm; Surgical excision of the gingival pyogenic granuloma	Drug: Solu-Cortef; A vial sol. used for intra-mascular injection; Other Names: Hydrocortisone
Experimental: Intervention; Intralesional injection with corticosteroids solution (1.8 mL of 100 mg hydrocortisone)	Drug: Solu-Cortef; A vial sol. used for intra-mascular injection; Other Names: Hydrocortisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remaining width of the attached gingiva	Remaining width of the attached gingival it is measured using graduated probe	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of the lesion	Assessed as clinical reoccurrence of the lesion at the same site	6 months

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Eman Magdy, PhD, lecturer

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): November 29, 2022
• Study Completion (Anticipated): November 29, 2022

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lymphoproliferative Disorders; Lymphatic Diseases; Granuloma; Granuloma, Pyogenic; Anti-Inflammatory Agents; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
• Other Study ID Numbers: 17/4/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No