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CompletedNCT04410679Updated Oct 8, 2021

Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technque

An interventional study of injectable PRF in Root Resorption, sponsored by Fayoum University. Completed at 1 site in Egypt. Open to participants aged 13 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-08.

Sponsored by Fayoum University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
13 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Root Resorption

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Keywords

  • Pulp revascularization
  • injectable Platelet rich fibrin
  • i-PRF
  • root resorption
  • CBCT
03

Who can participate

Ages eligible
13 Years to 30 Years
Sexes eligible
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

Exclusion Criteria:

  • old age
  • Medically medically compromised patients
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    injectabl PRF for treatment of internal root resorption

    Biological: injectable PRF

Interventions

  • Biologicalinjectable PRF

    blood sample and centrifuged to obtain i-PRF

05

What researchers measure

Primary outcomes

  1. change in volumetric size of internal root resorption lesions

    Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT

    Time frame: 12 months

Secondary outcomes

  1. change in volumetric size of periapical lesions

    Measuring volumetric dimensions of periapical lesion pre and postoperatively using CBCT

    Time frame: 12 months

06

Study locations

1 site
  • Faculty of dentistry Fayoum University
    Fayoum, Egypt
07

Registry details

Key details

Study ID
NCT04410679
Lead sponsor
Fayoum University
Responsible party
Mohamed Nageh (Lecturer of Endodontics, Fayoum University) — Principal investigator
First posted
Jun 1, 2020
Start date
Jun 3, 2018
Primary completion
Jun 6, 2019
Completion
May 2, 2020
Last update
Oct 8, 2021

Study contacts

Mohamed Nageh, Lecturer
principal investigator · Faculty of dentistry, Fayoum University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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