Histological/ Immunohistological and Molecularpathologica... | NCT03829059

Studies
Histological/ Immunohistological and Molecularpathological Types of Epulides and Central Giant Cell Lesions of the Jaws

NCT03829059

Sponsor

Medical University of Graz

Status

Active, not recruiting

Last Update Posted

Nov 20, 2024Actual

Enrollment

83Actual

Phase

Not provided

Conditions

Epulis

Interventions

Not provided

Countries

Austria

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

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Feb 2026Estimated

Completion Date

Feb 2026Estimated

First Submitted Date

Feb 1, 2019

First Submission Date that Met QC Criteria

Feb 1, 2019

First Posted Date

Feb 4, 2019Actual

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

Nov 19, 2024

Last Update Posted Date

Nov 20, 2024Actual

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

This retrospective study will evaluate the patient collective of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University Graz concerning the frequency of epulis/giant cell lesion or underlying differential diagnoses and immunophenotypes as well as the resulting treatment methods and their success and compare these with international results

Detailed Description

Different histopathological differential diagnoses can underlay the clinical presentation of an epulis. Often the immunophenotype of these lesions is of particular importance. This also holds for the the central giant cell lesion.

This study will evaluate the patient collective of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University Graz concerning the frequency of epulis/giant cell lesion or underlying differential diagnoses and immunophenotypes as well as the resulting treatment methods and their success and compare these with international results.

This is a retrospective study using electronic patient records, written records, operative reports of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University Graz in the period from 1986 to March 2018. It is intended to gather the data within 12 months and analyze statistically subsequently.

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

No data available

No data is available for this block.

Enrollment

83Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of histological pathological differential diagnoses.		time period of evaluation from 1986 to March 2018
Frequency of immunohistochemical pathological differential diagnoses.		time period: from 1986 to March 2018
Frequency of molecular pathological differential diagnoses.		time period from 1986 to March 2018

Secondary Outcomes

Measure	Description	Time Frame
Frequency of recurrences	depending on differential diagnoses and therapy	time period from 1986 to March 2018

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

existence of a medical history and a histopathological finding of the surgical specimen
patients treated in the outpatient clinic for diseases of oral mucosa of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University Graz between 1986 and March 2018

Exclusion Criteria:

absence of a medical history or a histopathological finding.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

95 Years

Standard Ages

ChildAdultOlder Adult

Study Population

The patient cohort comprises 101 patients treated in the outpatient clinic for diseases of oral mucosa of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University Graz in the period from 1986 to March 2018.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University		Graz		8036	Austria

Condition Browse Module

MeSH Terms

ID	Term
D005882	Gingival Diseases

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided