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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04410679
Other study ID # FayoumU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2018
Est. completion date May 2, 2020

Study information

Verified date October 2021
Source Fayoum University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 2, 2020
Est. primary completion date June 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Faculty of dentistry Fayoum University Fayoum

Sponsors (1)

Lead Sponsor Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in volumetric size of internal root resorption lesions Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT 12 months
Secondary change in volumetric size of periapical lesions Measuring volumetric dimensions of periapical lesion pre and postoperatively using CBCT 12 months
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