NCT04410679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

May 27, 2020

Last Update Submit

October 1, 2021

Conditions

Root Resorption

Keywords

Pulp revascularizationinjectable Platelet rich fibrini-PRFroot resorptionCBCT

Outcome Measures

Primary Outcomes (1)

  • change in volumetric size of internal root resorption lesions

    Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT

    12 months

Secondary Outcomes (1)

  • change in volumetric size of periapical lesions

    12 months

Study Arms (1)

injectabl PRF for treatment of internal root resorption

EXPERIMENTAL
Biological: injectable PRF

Interventions

injectable PRFBIOLOGICAL

blood sample and centrifuged to obtain i-PRF

injectabl PRF for treatment of internal root resorption

Eligibility Criteria

Age13 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • old age
  • Medically medically compromised patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry Fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Study Officials

  • Mohamed Nageh, Lecturer

    Faculty of dentistry, Fayoum University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Endodontics

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 1, 2020

Study Start

June 3, 2018

Primary Completion

June 6, 2019

Study Completion

May 2, 2020

Last Updated

October 8, 2021

Record last verified: 2021-10

Locations

EG(1)