Back to resultsCorticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone.
Primary Purpose
Oral Pyogenic Granuloma
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Solu-Cortef
Sponsored by
About this trial
This is an interventional treatment trial for Oral Pyogenic Granuloma
Eligibility Criteria
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
Sites / Locations
- Beni_Suef UniversityRecruiting
- Eman AhmedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control arm
Intervention
Arm Description
Surgical excision of the gingival pyogenic granuloma
Intralesional injection with corticosteroids solution (1.8 mL of 100 mg hydrocortisone)
Outcomes
Primary Outcome Measures
Remaining width of the attached gingiva
Remaining width of the attached gingival it is measured using graduated probe
Secondary Outcome Measures
Recurrence of the lesion
Assessed as clinical reoccurrence of the lesion at the same site
Full Information
NCT ID
NCT05534334
First Posted
September 6, 2022
Last Updated
September 12, 2022
Sponsor
Beni-Suef University
1. Study Identification
Unique Protocol Identification Number
NCT05534334
Brief Title
Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone.
Official Title
Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 29, 2022 (Anticipated)
Study Completion Date
November 29, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
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
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Pyogenic Granuloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Surgical excision of the gingival pyogenic granuloma
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intralesional injection with corticosteroids solution (1.8 mL of 100 mg hydrocortisone)
Intervention Type
Drug
Intervention Name(s)
Solu-Cortef
Other Intervention Name(s)
Hydrocortisone
Intervention Description
A vial sol. used for intra-mascular injection
Primary Outcome Measure Information:
Title
Remaining width of the attached gingiva
Description
Remaining width of the attached gingival it is measured using graduated probe
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Recurrence of the lesion
Description
Assessed as clinical reoccurrence of the lesion at the same site
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Magdy, PhD
Phone
01001077882
Email
emysanfora82@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Magdy, PhD
Phone
01142131053
Email
dentistsherif@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Magdy, PhD
Organizational Affiliation
Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni_Suef University
City
Banī Suwayf
State/Province
Bani Suwayf
ZIP/Postal Code
1172
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman Magsy, Lecturer
Phone
01001077882
Email
emanmagdy@dent.bsu.edu.eg
Facility Name
Eman Ahmed
City
Banī Suwayf
State/Province
Benisuef
ZIP/Postal Code
1178
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman Ahmed, PhD
Phone
01001077882
Email
emanmagdy@dent.bsu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone.
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