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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04330768

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dental Pulp Exposure Dental Caries	Procedure: PRF pulp capping Procedure: MTA pulp capping	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Platelet Rich Fibrin(PRF) Versus Pulp Capping in Treatment of Dental Pulp Exposure:Randomized Clinical Trial

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRF	Procedure: PRF pulp capping PRF is injected in the site of exposure
Active Comparator: MTA	Procedure: MTA pulp capping conventional pulp capping procedure

Arm

Intervention/Treatment

Experimental: PRF

Procedure: PRF pulp capping

PRF is injected in the site of exposure

Active Comparator: MTA

Procedure: MTA pulp capping

conventional pulp capping procedure

Outcome Measures

Primary Outcome Measures

pulp vitality [After 1 year]
no sign of irreversible pulpitis or pulpal necrosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

deep carious lesion- no sign of irreversible pulpitis

Exclusion Criteria:

old age- periapical lesion-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dina mounir elkady, Lecturer at conservative department, Cairo University

ClinicalTrials.gov Identifier:

NCT04330768

Other Study ID Numbers:

0555

First Posted:

Apr 1, 2020

Last Update Posted:

Apr 2, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Dental Pulp Exposure

Study Results

No Results Posted as of Apr 2, 2020