Healing Assessment of Osseous Defects After Surgical Remo... | NCT05100615

Studies
Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions

NCT05100615

Sponsor

Minia University

Status

Unknown status

Last Update Posted

Oct 29, 2021Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Effects of the Elements

Interventions

surgery

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

Oct 2021

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

Nov 2021Estimated

Primary Completion Date

May 2022Estimated

Completion Date

May 2022Estimated

First Submitted Date

Sep 28, 2021

First Submission Date that Met QC Criteria

Oct 20, 2021

First Posted Date

Oct 29, 2021Actual

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

Oct 20, 2021

Last Update Posted Date

Oct 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amira mohammed elkholly, phD student- Endodontic Departement, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

recruited patients with periapical lesions will be divided into three groups and surgically treated with three types of bone graft (hydroxyappatite, nanohydroxyappatite and PRF WITH NANOHYDROXTAPPATITE) and then evaluated for month, three months and six months for the healing of periapical bone

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hydroxyappatite	Other	hydroxyapatite powder used for enhancement of bone regeneration	Procedure: surgery
nanohydroxyapatite	Other	nanohydroxyapatite powder used for enhancement of bone regeneration	Procedure: surgery
PRF with nanohydroxyapatite	Other	platelet rich fibrin mixed with nanohydroxyapatite used for enhancement of bone regeneration	Procedure: surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery	Procedure	applying the graft inside bony defect after surgery	PRF with nanohydroxyapatite hydroxyappatite nanohydroxyapatite

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
healing of periapical lesion	change in size of bony defect	interappointment at 1 month, 3 months and 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient will be in range of 20-45 years of age at the time of treatment, having periapical lesions starting from 5mm or more in diameter related to failed endodontically treated single canaled teeth.

Exclusion Criteria:

Any systemic debilitating disease such as:

Diabetes mellitus, renal disease, Liver disease or liver failure, Rheumatoid arthritis, Neoplastic disease or its treatment, chronic corticosteroid therapy, chronic hepatitis B or C , History of hepatitis A, pregnant females.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amira Elkholly, PHD	Contact	+201001902507	Egypt	dr.amiraelkholly@yahoo.com
Reham Hassan, Ass.prof	Contact	+201001542529	Egypt	reham-hassan@live.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amira mohammed fathy Elkholly	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided