Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technque

Sponsor
Fayoum University (Other)
Overall Status
Completed
CT.gov ID
NCT04410679
Collaborator
(none)
10
1
1
23
0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: injectable PRF
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technique: A Clinical Study With Cone Beam Computed Tomography Evaluation
Actual Study Start Date :
Jun 3, 2018
Actual Primary Completion Date :
Jun 6, 2019
Actual Study Completion Date :
May 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: injectabl PRF for treatment of internal root resorption

Biological: injectable PRF
blood sample and centrifuged to obtain i-PRF

Outcome Measures

Primary Outcome Measures

  1. change in volumetric size of internal root resorption lesions [12 months]

    Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT

Secondary Outcome Measures

  1. change in volumetric size of periapical lesions [12 months]

    Measuring volumetric dimensions of periapical lesion pre and postoperatively using CBCT

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of dentistry Fayoum University Fayoum Egypt

Sponsors and Collaborators

  • Fayoum University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Nageh, Lecturer of Endodontics, Fayoum University
ClinicalTrials.gov Identifier:
NCT04410679
Other Study ID Numbers:
  • FayoumU
First Posted:
Jun 1, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Nageh, Lecturer of Endodontics, Fayoum University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021