Platelet Rich Fibrin(PRF) Injection for Treatment of Dent... | NCT04330768

Studies
Platelet Rich Fibrin(PRF) Injection for Treatment of Dental Pulp Exposure:Randomized Clinical Trial

NCT04330768

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 2, 2020Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Dental Pulp Exposure
Dental Caries

Interventions

PRF pulp capping
MTA pulp capping

Countries

Not provided

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2021Estimated

Primary Completion Date

Mar 2022Estimated

Completion Date

Jun 2022Estimated

First Submitted Date

Mar 30, 2020

First Submission Date that Met QC Criteria

Mar 31, 2020

First Posted Date

Apr 1, 2020Actual

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

Mar 31, 2020

Last Update Posted Date

Apr 2, 2020Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

platelet rich fibrin(PRF) obtained from patient from patient blood sample (before start of treatment)is injected in the site of exposure of exposure(intervention group) control group will receive normal pulp capping procedure by MTA follow up will be one year

Detailed Description

intervention group:patient with deep caries lesion ,free from sign and symptoms of irreversible pulpitis the blood sample will be taken before the beginning of dental treatment..PRF will be obtained by blood centrifugal and injected in the site of exposure covered by glass ionomer restoration control group: patient with same condition will receive pulp capping procedure by MTA followed by glass ionomer restoration

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRF	Experimental		Procedure: PRF pulp capping
MTA	Active Comparator		Procedure: MTA pulp capping

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRF pulp capping	Procedure	PRF is injected in the site of exposure	PRF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pulp vitality	no sign of irreversible pulpitis or pulpal necrosis	After 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

deep carious lesion- no sign of irreversible pulpitis

Exclusion Criteria:

old age- periapical lesion-

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D003789	Dental Pulp Exposure
D003731	Dental Caries

Ancestor Terms

ID	Term
D003788	Dental Pulp Diseases
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D017001	Tooth Demineralization

Browse Leaves

Not provided

Browse Branches

Not provided