Management of Plasma Cell Gingivitis by Two Surgical Tech... | NCT05236322

Studies
Management of Plasma Cell Gingivitis by Two Surgical Techniques

NCT05236322

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Feb 11, 2022Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Plasma Cell Gingivitis

Interventions

soft tissue laser

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

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Jan 10, 2022Actual

Completion Date

Jan 20, 2022Actual

First Submitted Date

Jan 23, 2022

First Submission Date that Met QC Criteria

Feb 2, 2022

First Posted Date

Feb 11, 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

Feb 2, 2022

Last Update Posted Date

Feb 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yasser Mohamed Nabil Ahmed Khirat El Hadidi, principle investigator, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Two surgical protocols for management of Plasma cell Ginigivitis; either by surgical enblock resection of cold laser resection

Detailed Description

Tow groups will be included the first will have six cases and second will have six cases. the first will be treated by ordinary surgical resection and second will be removed using soft tissue laser.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group		Removal by soft tissue laser of the tumor	Device: soft tissue laser
control group		Removal by ordinary surgical scalpel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
soft tissue laser	Device	Surgical laser used in excision purpose	study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete removal	complete removal of lesion with safety margin	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- patients suffering from the plasma cell gingivitis

Exclusion Criteria:

- Patient not eligible for maxillofacial surgery

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

Patient suffering from plasma cell gingivitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mohamed diaa, professor	Ain Shams University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams University		Cairo		11757	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

yes planning to share

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided