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

Sponsor
Beni-Suef University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05534334
Collaborator
(none)
30
Enrollment
2
Locations
2
Arms
7
Anticipated Duration (Months)
15
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Nov 29, 2022
Anticipated Study Completion Date :
Nov 29, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Remaining width of the attached gingiva [6 month]

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

    Secondary Outcome Measures

    1. Recurrence of the lesion [6 months]

      Assessed as clinical reoccurrence of the lesion at the same site

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni_Suef University Banī Suwayf Bani Suwayf Egypt 1172
    2 Eman Ahmed Banī Suwayf Benisuef Egypt 1178

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    • Principal Investigator: Eman Magdy, PhD, Lecturer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eman Magdy Ahmed, Principal Investigator, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05534334
    Other Study ID Numbers:
    • 17/4/21
    First Posted:
    Sep 9, 2022
    Last Update Posted:
    Sep 14, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Granuloma
    Granuloma, Pyogenic
    Hydrocortisone
    Hydrocortisone 17-butyrate 21-propionate
    Hydrocortisone acetate
    Hydrocortisone hemisuccinate

    Study Results

    No Results Posted as of Sep 14, 2022