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Regenerative Endodontic ProceduresNCT07355686

Success of Endodontic Regenerative Approaches in Anterior and Posterior Immature Non Vital Teeth

A study testing endodontic regenerative procedure using blood clot and endodontic regenerative procedure using platelet rich fibrin in people with Regenerative Endodontic Procedures, run by Future University in Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim of the Study To compare between anterior and posterior immature non vital teeth regarding: 1. Primary outcome: Resolution of apical periodontitis. 2. Secondary outcome: a) Increase in root length b) Increase in root width c) Decrease in apical area Using the following techniques: 1. Read more about this study

Who is it for?
Ages 8 to 15 years
Conditions the study is for
Regenerative Endodontic Procedures
What is being tested?
endodontic regenerative procedure using blood clot and endodontic regenerative procedure using platelet rich fibrin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
2 Sep 2023to 1 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • • Age 8-15.
  • Medically free.
  • Single rooted immature necrotic permanent teeth.
  • Tooth without vertical root fracture or resorption.
  • Compliant patient/parent.
  • Patient not allergic to medicaments and antibiotics necessary to complete procedure.

Who cannot join

  • Avulsed teeth immediately after replantation (as revitalization may occur naturally).
  • Luxation injuries.
  • Impossibility of adequate tooth isolation.
  • Teeth with extensive loss of coronal tissue that require restoration with a post that will occupy the space required for blood clot formation.
  • Medically compromised patients.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Future University in Egypt

    Cairo, New Cairo, 11835

Other trials in Egypt

About this study

Official title: Success of Endodontic Regenerative Approaches in Anterior and Posterior Immature Non Vital Teeth A Randomized Controlled Clinical Trial

Aim of the Study

To compare between anterior and posterior immature non vital teeth regarding:

Read more
  1. Primary outcome: Resolution of apical periodontitis.
  2. Secondary outcome: a) Increase in root length b) Increase in root width c) Decrease in apical area

Using the following techniques:

  1. Blood clot revascularization (BC).
  2. Platelet-rich fibrin (PRF).

Methods:

  1. Diagnosis: Diagnostic data was collected \& recorded in a medical \& dental history sheet. A full history of the chief complaint was recorded including the intensity, nature, quality, onset, location, duration, course as well as initiating \& relieving factors of pain (if present). Clinical Examination:
  • Visual examination using mirror \& probe to detect caries, previous restorations or discoloration. - Examination of the Intraoral tissues for the detection of any swelling or sinus tract related to the tooth.
  • Palpation, Percussion, Bite \& Mobility tests was done to evaluate the periapical \& periodontal status of the involved tooth.
  • Periodontal probing of pocket depth was recorded for each of the involved teeth at 6 points: Mesiobuccally, Mid buccally, Distobuccally, Mesiolingually, Mid lingually \& Distolingually.
  • Pulp Sensibility tests, both Thermal (cold) \& Electrical was done \& recorded for the involved tooth as well as the contralateral tooth, in order to affirm the diagnosis as well as to serve as a reference for follow up. Radiographic examination:
  • An Intraoral periapical digital radiograph with standardized paralleling angle technique using XCP film holder \& standardized exposure settings (60 kV, 7 mA \& 0.160) was taken pre-operatively for the involved tooth using a size 2 PSP imaging plate.
  • Pre-operative CBCT with a limited field of view (40×40) was done in which the lesion size, bone density in the area of periapical lesion \& normal adjoining bony regions, \& the length \& width of the roots along with the diameter of the apex will be measured.
  1. clinical procedure:

The clinical procedures was done (according to the guide lines of the American Association of Endodontics over 2 visits that are 2 weeks apart, unless persistence of clinical signs \& symptoms occur.

First appointment:

  1. Patients was given local anesthesia.
  2. Dental dam isolation then access was done.
  3. Minimal circumferential filing using hand files along with Copious, gentle irrigation will be done in the canals with 1.5% sodium hypochlorite ( NaOCl) (20mL) using needle with closed end and side-vents to minimize the possibility of extrusion of solutions into the periapical space and then will be irrigated with 17% ethylene diamine tetra acetic acid (EDTA) (20 mL), with irrigating needle positioned about 1 mm from root end.
  4. Canals was dried using paper points.
  5. Calcium hydroxide (CH) was injected using 29gauge NaviTip to the full length of the canals.
  6. Access was sealed with 3-4mm of glass ionomer then patient will be dismissed for 1-4 weeks.

Second appointment: (regeneration procedure):

2 weeks after the first visit: For the four groups final visit was scheduled when tooth is asymptomatic and no signs of discharge. In cases of persistent infection one or more visits will be scheduled for discharge and disinfection.

  1. The patients was given anesthesia without vasoconstrictor, proper isolation will be done; the temporary restoration and cotton pellet was removed.
  2. Canals were irrigated with 20 ml of 17% EDTA for 1 minute.
  3. Canals were then dried using sterile paper points.
  4. In group I and group III: sterile hand file size #50 will be used in sharp strokes 2mm beyond the apex into the peri-apical tissues until bleeding is evident in cervical portion of the canal.
  5. In group II and group IV: The prepared PRF will be inserted into the root canal orifice and plugged into the premeasured length of the root canal using endodontic pluggers up to 1 mm below the root canal orifice.
  6. Collagen matrix was placed at the orifice, over the blood clot and white mineral trioxide aggregate (MTA )to seal the canal orifice with a wet sterile cotton pellet above. Temporary filling will be used to seal the cavity.
  7. After 2 days adhesive composite resin was used to seal the access cavity.
Being tested
endodontic regenerative procedure using blood clot, endodontic regenerative procedure using platelet rich fibrin
Keywords
regereration, immature teeth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endodontic regenerative procedure using blood clotProcedure or surgery

    regenerative endodontic procedure according to the American association of endodontics while using blood clot as a scaffold

  • endodontic regenerative procedure using platelet rich fibrinProcedure or surgery

    regenerative endodontic procedure according to the American association of endodontics guidelines while using Palette rich fibrin as a scaffold

Study groups in NCT07355686
Study groupRoleWhat they receive
Immature non-vital anterior teeth treated using palette rich fibrinActive comparatorNot described
Receives: Procedure: endodontic regenerative procedure using platelet rich fibrin
Immature non-vital anterior teeth treated using blood clotActive comparatorNot described
Receives: Procedure: endodontic regenerative procedure using blood clot
Immature non-vital molar teeth treated using palette rich fibrinActive comparatorNot described
Receives: Procedure: endodontic regenerative procedure using platelet rich fibrin
Immature non-vital molar teeth treated using blood clotActive comparatorNot described
Receives: Procedure: endodontic regenerative procedure using blood clot

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percent of change in apical lesion size

    ▪ Radiographically using cone beam computed tomography: percent of change in periapical lesion size in cubic millimeters

    Measured: 1 year

Secondary outcomes (3)
  1. percent of change in root length

    Radiographically using CBCT: percent of change in length in millimeters

    Measured: 1 year

  2. percent of change in apical area

    Radiographically using CBCT: percent of change in apical area in squared millimeters.

    Measured: 1 year

  3. percent of change in root width

    Radiographically using CBCT: percent of change in root width in millimeters

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start2 Sep 2023
  3. Primary completion1 Jun 2025
  4. Study completion1 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07355686
Sponsor's protocol ID
FADASU-Rec D032121
Status last verified
Dec 2025
First submitted
2 Dec 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing endodontic regenerative procedure using blood clot and endodontic regenerative procedure using platelet rich fibrin in people with Regenerative Endodontic Procedures, run by Future University in Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percent of change in apical lesion size (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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