Corticosteroid Intralesional Injection as an Alternative... | NCT05534334

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

NCT05534334

Sponsor

Beni-Suef University

Status

Unknown status

Last Update Posted

Sep 14, 2022Actual

Enrollment

30Estimated

Phase

Phase 2Phase 3

Conditions

Oral Pyogenic Granuloma

Interventions

Solu-Cortef

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Nov 29, 2022Estimated

Completion Date

Nov 29, 2022Estimated

First Submitted Date

Sep 6, 2022

First Submission Date that Met QC Criteria

Sep 6, 2022

First Posted Date

Sep 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2022

Last Update Posted Date

Sep 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control arm	Active Comparator	Surgical excision of the gingival pyogenic granuloma	Drug: Solu-Cortef
Intervention	Experimental	Intralesional injection with corticosteroids solution (1.8 mL of 100 mg hydrocortisone)	Drug: Solu-Cortef

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Solu-Cortef	Drug	A vial sol. used for intra-mascular injection	Control arm Intervention

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eman Magdy, PhD	Contact	01001077882		emysanfora82@yahoo.com
Eman Magdy, PhD	Contact	01142131053		dentistsherif@gmail.com

Overall Officials

Name	Affiliation	Role
Eman Magdy, PhD	Lecturer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni_Suef University	Recruiting	Banī Suwayf	Beni Suweif Governorate	1172	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C007133	hydrocortisone hemisuccinate
D006854	Hydrocortisone

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided