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.
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.
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
- Primary outcome: Resolution of apical periodontitis.
- Secondary outcome: a) Increase in root length b) Increase in root width c) Decrease in apical area
Using the following techniques:
- Blood clot revascularization (BC).
- Platelet-rich fibrin (PRF).
Methods:
- 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.
- 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:
- Patients was given local anesthesia.
- Dental dam isolation then access was done.
- 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.
- Canals was dried using paper points.
- Calcium hydroxide (CH) was injected using 29gauge NaviTip to the full length of the canals.
- 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.
- The patients was given anesthesia without vasoconstrictor, proper isolation will be done; the temporary restoration and cotton pellet was removed.
- Canals were irrigated with 20 ml of 17% EDTA for 1 minute.
- Canals were then dried using sterile paper points.
- 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.
- 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.
- 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.
- After 2 days adhesive composite resin was used to seal the access cavity.
- Conditions
- Regenerative Endodontic Procedures
- 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 group | Role | What they receive |
|---|---|---|
| Immature non-vital anterior teeth treated using palette rich fibrin | Active comparator | Not described Receives: Procedure: endodontic regenerative procedure using platelet rich fibrin |
| Immature non-vital anterior teeth treated using blood clot | Active comparator | Not described Receives: Procedure: endodontic regenerative procedure using blood clot |
| Immature non-vital molar teeth treated using palette rich fibrin | Active comparator | Not described Receives: Procedure: endodontic regenerative procedure using platelet rich fibrin |
| Immature non-vital molar teeth treated using blood clot | Active comparator | Not 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.
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)
percent of change in root length
Radiographically using CBCT: percent of change in length in millimeters
Measured: 1 year
percent of change in apical area
Radiographically using CBCT: percent of change in apical area in squared millimeters.
Measured: 1 year
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.
- First posted21 Jan 2026
- Study start2 Sep 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative Endodontic ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholoud Emam, Future University in Egypt
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success of Endodontic Regenerative Approaches in Anterior and Posterior Immature Non Vital Teeth A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07355686
- Acronym / sponsor ID
- FADASU-Rec D032121
- Conditions
- Regenerative Endodontic Procedures
- Keywords
- regereration, immature teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the Study
To compare between anterior and posterior immature non vital teeth regarding:
- Primary outcome: Resolution of apical periodontitis.
- Secondary outcome: a) Increase in root length b) Increase in root width c) Decrease in apical area
Using the following techniques:
- Blood clot revascularization (BC).
- Platelet-rich fibrin (PRF).
Methods:
- 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.
- 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:
- Patients was given local anesthesia.
- Dental dam isolation then access was done.
- 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.
- Canals was dried using paper points.
- Calcium hydroxide (CH) was injected using 29gauge NaviTip to the full length of the canals.
- 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.
- The patients was given anesthesia without vasoconstrictor, proper isolation will be done; the temporary restoration and cotton pellet was removed.
- Canals were irrigated with 20 ml of 17% EDTA for 1 minute.
- Canals were then dried using sterile paper points.
- 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.
- 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.
- 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.
- After 2 days adhesive composite resin was used to seal the access cavity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immature non-vital anterior teeth treated using palette rich fibrin | Active comparator | Procedure: endodontic regenerative procedure using platelet rich fibrin |
| Immature non-vital anterior teeth treated using blood clot | Active comparator | Procedure: endodontic regenerative procedure using blood clot |
| Immature non-vital molar teeth treated using palette rich fibrin | Active comparator | Procedure: endodontic regenerative procedure using platelet rich fibrin |
| Immature non-vital molar teeth treated using blood clot | Active comparator | Procedure: endodontic regenerative procedure using blood clot |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- • Age 8-15.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endodontic regenerative procedure using blood clotregenerative endodontic procedure according to the American association of endodontics while using blood clot as a scaffold | Procedure or surgery | Immature non-vital anterior teeth treated using blood clot, Immature non-vital molar teeth treated using blood clot |
| endodontic regenerative procedure using platelet rich fibrinregenerative endodontic procedure according to the American association of endodontics guidelines while using Palette rich fibrin as a scaffold | Procedure or surgery | Immature non-vital anterior teeth treated using palette rich fibrin, Immature non-vital molar teeth treated using palette rich fibrin |
Primary outcome
percent of change in apical lesion size
Time frame: 1 year
▪ Radiographically using cone beam computed tomography: percent of change in periapical lesion size in cubic millimeters
3 secondary outcomes
percent of change in root length
Time frame: 1 year
percent of change in apical area
Time frame: 1 year
percent of change in root width
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Regenerative Endodontic Procedures
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The Effect of Using Different Scaffolds in Retreated Teeth on The Clinical and Radiological Success of Regenerative Endodontic Treatment
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Regenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.