Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technque

October 1, 2021 updated by: Mohamed Nageh, Fayoum University

Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technique: A Clinical Study With Cone Beam Computed Tomography Evaluation

Currently Endodontics looks forward for regeneration rather than repair. Regenerative endodontic therapy was limited to pulp revascularization of necrotic pulp in immature teeth , followed by mature teeth. Recently pulp revascularization technique by induction of blood clot was applied in the treatment of inflammatory root resorption. So far, no clinical study for management of teeth with inflammatory internal root resorption by using injectable PRF revascularization has been described in the literature. Thus, this is the first clinical attempt to manage inflammatory root resorption in necrotic incisor teeth using injectable PRF regenerative approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

13 teeth in a total of 10 patients with inflammatory root resorption will be treated using revascualrization technique, iPRF will be prepared and unjected in the canal after previous canal disinfection with calcium hydroxide for 2-4 weeks. cBCT will be taken preoperative and 12 month follow up period, also clinical and radiographic follow uo will be considered every 3 months for 1 year.

Study Type

Interventional

Enrollment (Actual)

10

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 Locations

  • Egypt
      • Fayoum, Egypt
        • faculty of dentistry Fayoum university

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

13 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients 13-30 years old
  • no sex predilection
  • medically free
  • Suffering from internal inflammatory root resorption in permanent anterior mature teeth
  • associated with or without periapical radiolucency
  • no or grade I tooth mobility, and a pocket depth <3 mm

Exclusion Criteria:

  • old age
  • Medically medically compromised patients

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: injectabl PRF for treatment of internal root resorption
Biological: injectable PRF
blood sample and centrifuged to obtain i-PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in volumetric size of internal root resorption lesions
Time Frame: 12 months
Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in volumetric size of periapical lesions
Time Frame: 12 months
Measuring volumetric dimensions of periapical lesion pre and postoperatively using CBCT
12 months

Collaborators and Investigators

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

Sponsor

Fayoum University

Investigators

  • Principal Investigator: Mohamed Nageh, Lecturer, Faculty of dentistry, Fayoum University

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 (Actual)

June 3, 2018

Primary Completion (Actual)

June 6, 2019

Study Completion (Actual)

May 2, 2020

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FayoumU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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