NCT06227533

Brief Summary

This study was performed to compare endodontic regeneration outcome in necrotic mature single rooted teeth with periapical radiolucency using platelet rich fibrin (PRF) \& concentrated growth factor (CGF) as a different natural scaffold by evaluation of:

  • Regaining pulp sensibility by thermal test (hot and cold)
  • Periapical healing using digital radiography and selected samples will be evaluated using Cone Beam Computed Tomography (CBCT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

January 16, 2024

Last Update Submit

January 25, 2024

Conditions

Pulp Necroses

Keywords

regeneration, mature teeth

Outcome Measures

Primary Outcomes (1)

  • healing

    The elimination of symptoms and the evidence of periapical bony healing assessed radiographically (incidence of bone formation at the apex of root which indicate complete healing of chronic periapical abscess which assessed by periapical radiograph and cbct at 6 months \& 1 year after treatment , as it appear radiolucency in radiograph which decrease by time that indicate complete healing of abscess and reformation of bone apically

    1 year

Secondary Outcomes (1)

  • regaining of pulp sensibility

    1 year

Study Arms (2)

PRF group

EXPERIMENTAL

Five ml blood will be drawn from the patient's right median cubital vein into a test tube without the addition of an anticoagulant and centrifuged immediately at 3000 rpm for 10 minutes

Procedure: Endodontic regeneration using concentrated growth factor compared with Platelet rich fibrin

CGF group

EXPERIMENTAL

Ten ml of intravenous blood sample from the patient will be obtained and placed in centrifuge tubes without anticoagulants; accelerated for 30 seconds; centrifuged at 2700 rpm for 2 min, 2400 rpm for 4 min, 2700 rpm for 4 min, and 3000 rpm for 3 min; and decelerated for 36 secs to stop

Procedure: Endodontic regeneration using concentrated growth factor compared with Platelet rich fibrin

Interventions

Endodontic regeneration using concentrated growth factor compared with Platelet rich fibrinPROCEDURE

regeneration of mature necrotic teeth with periapical abscess using concentrated growth factor compared with Platelet rich fibrin to allow healing of periapical lesion and regaining sensibility

Also known as: Endodontic regeneration of mature teeth
CGF groupPRF group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Agree to participate in this study and provide informed consent
  • Age range of 18 - 30 years
  • Free from systemic diseases.
  • Having necrotic single-rooted maxillary central incisor with mature root and periapical radiolucency sized up to 5mm.
  • Restorable teeth that can be isolated with rubber dam and restored with direct coronal restoration.

You may not qualify if:

  • Pregnant females.
  • Generalized chronic periodontitis.
  • Non-restorable teeth.
  • Previous root canal treatment.
  • Developmental anomalies.
  • External and / or internal root resorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dental medicine for girls Al Azhar University

Cairo, Egypt

Location

Related Publications (1)

  • Salah T, Hussein W, Abdelkafy H. Regenerative potential of concentrated growth factor compared to platelet-rich fibrin in treatment of necrotic mature teeth: a randomized clinical trial. BDJ Open. 2025 Feb 3;11(1):10. doi: 10.1038/s41405-024-00288-3.

    PMID: 39900647DERIVED

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • heba abd el kafy, lecturer

    faculty of dental medicine for girls Al Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Eighteen papers were numbered from 1 to 18 and individually packed in opaque envelopes. Each patient picked an envelope before the beginning of the second visit. The number in the envelope determined the regenerative protocol which was to be performed for the participant. The patient was not informed of what procedure he/she was subjected to
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The current study was designed as randomized controlled clinical trial with an allocation ratio 1:1
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer assistant

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 29, 2024

Study Start

November 1, 2021

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations

EG(1)