Concentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors

August 28, 2022 updated by: Ahmad Elheeny
Regenerative endodontic procedures (REPs) are the most recent proposal to manage immature permanent teeth with necrotic pulps. So in this study, the investigator will evaluate the clinical and radiographical revitalization success in necrotic young permanent anterior teeth of participants by using Concentrated Growth Factor versus Platelet-Rich Fibrin

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

has been entered

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy patients with immature permanent incisors
  • Presence of clinical signs and symptoms of necrosis or chronic apical periodontitis. The chronic apical periodontitis signs and symptoms include little discomfort with intermittent episodes of pus discharge through the sinus tract.

Exclusion Criteria

1. Abnormal tooth mobility.

  • Positive history of allergic reaction, systemic diseases, severe emotional or behavioral problems.
  • Unrestorable teeth
  • Abnormal tooth mobility
  • Children with systemic, severe behavioral, or emotional problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: revitalization by concentrated growth factor
modified platelet concentrate
Procedure: revitalization by concentrated growth factor
modified platelet concentrate
Other Names:
  • revitalization by platelet rich fibrin
Active Comparator: revitalization by platelet rich fibrin
platelet concentrate
Procedure: revitalization by concentrated growth factor
modified platelet concentrate
Other Names:
  • revitalization by platelet rich fibrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success rate
Time Frame: one year
Regaining tooth vitality with electric pulp testing Clinical examination includes pain absence, normal tooth mobility, and no sensitivity to percussion
one year
Radiographic success using Periapical index (PAI)
Time Frame: one year

Criteria of PAI scores:

score "1" normal periapical structure score "2" small changes in bone structures score "3" changes in bone structure with some mineral loss score "4" periodontitis with well-defined radiolucent area score "5" severe periodontitis with exacerbating features
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmad Elheeny

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 28, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 28, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

12 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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