Revascularization of Immature Permenant TeethNCT07913880
Revascularization of Immature Teeth With Our Different Scaffolds
A study testing Blood Clot, Platelet Rich Plasma and Platelet Rich Fibrin in people with Revascularization of Immature Permenant Teeth, run by Tanta University at 1 site in Egypt.
Trial summary
the study concern with the patients who loss the vitality of their teeth before completion of root development and apply new treatment approaches to restore their vitality through different scaffolds applied in inside the root canal and allow growth completion of their immature root Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Revascularization of Immature Permenant Teeth
- What is being tested?
- Blood Clot, Platelet Rich Plasma and Platelet Rich Fibrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 10 Jan 2026
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria comprised medically healthy patients with clinical findings consistent with pulpal necrosis, with or without an associated periapical lesion, and radiographic evidence of incomplete root development, defined by an apical diameter >1 mm
Who cannot join
- Teeth were excluded if they exhibited a vital pulp and/or complete root maturation, were non-restorable, demonstrated radiographic evidence of root fracture, or if the patient had allergy to any medication or material required for the treatment protocol. Teeth associated with periodontal probing depths >4 mm were also excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Regenerative Potential of Four Different Biological Scaffolds in Treatment of Non Vital Immature Permanent Maxillary Incisors (A Randomized Controlled Clinical Trial)
the study concern with the patients who loss the vitality of their teeth before completion of root development and apply new treatment approaches to restore their vitality through different scaffolds applied in inside the root canal and allow growth completion of their immature root
Read the detailed description
the study assess the regenerative potential of four different biological scaffolds Blood Clot, Platelet rich plasma, Platelet rich fibrin and Collagen membrane as a new treatment modality for non-vital immature permanent incisors
- Being tested
- Blood Clot, Platelet Rich Plasma, Platelet Rich Fibrin, Collagen Membrane
- Keywords
- Blood clot, Collagen membrane, Cone beam computed tomography, Platelet rich fibrin, Platelet rich plasma, Scaffold
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood ClotOther
regenerative endodontic treatment using blood clot as scaffold
Platelet Rich PlasmaOther
regenerative endodontic treatment using platelet rich plasma as scaffold
Platelet Rich FibrinOther
regenerative endodontic treatment using platelet rich fibrin as scaffold
Collagen MembraneOther
regenerative endodontic treatment using collagen membrane as scaffold
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | For Blood Clot scaffold group, intracanal bleeding was intentionally induced by gently extending a sterile #40 stainless-steel K-file 1-2 mm beyond the apical foramen into the periapical tissues. Bleeding was allowed to reach at least 3 mm below the level of the CEJ, any excess blood above the CEJ coronally was removed with a suitable size of sterile paper points. After waiting nearly 10 minutes, the integrity of the newly formed clot was detected using a suitable sterile paper point Receives: Other: Blood Clot |
| Group II | Active comparator | For PRP group, 5 mL of peripheral venous blood was obtained from the antecubital vein of each patient by venipuncture and collected into a 10 mL sterile glass tube containing acid citrate dextrose as an anticoagulant. The blood sample was initially centrifuged at 2400 rpm for 10 minutes to separate PRP and platelet-poor plasma (PPP) from the erythrocyte fraction. Following the first centrifugation cycle, three distinct layers were observed within the tube.; a bottom red thick layer containing red blood cells, a central buffy lightly yellowish layer containing white blood cells and plasma cells, and a supernatant turbid liquid layer which is acellular plasma.
Supernatant layer (PRP + PPP) was carefully transferred to a sterile tube and subjected to a second centrifugation at 3600 rpm for 15 minutes to further separate the PRP from the PPP. After the second centrifugation cycle, PRP precipitated at the bottom of the tube as light yellowish slimy viscous substance which was retri Receives: Other: Platelet Rich Plasma |
| Group III | Active comparator | For PRF group, 5 mL of the own venous blood was collected from the patient arm then was placed in a sterile tube without anticoagulant and centrifuged immediately at 3000 rpm for 10 minutes using a centrifuge machine . Three layers were formed inside each tube: a base layer containing erythrocytes, an intermediate layer of PRF clot, and a surface layer of acellular plasma. The PRF clot was removed from the test tube with sterile cotton plier and then put on a sterile gauze then cleared from the base erythrocyte layer using sterile scissor. The freshly prepared PRF clot was compressed between two sterile gauze pieces to form a membrane. The freshly prepared PRF membrane was sectioned into small fragments using sterile #15 scalpel blade and was placed incrementally inside root canal till the full WL length and nearly up to 3 mm below the level of the CEJ. A sterile hand plugger of appropriate size, adjusted to a length 2-3 mm shorter than the WL, was used to facilitate controlled place Receives: Other: Platelet Rich Fibrin |
| Group IV | Active comparator | The collagen membrane scaffold, supplied in a 15 × 20 mm dimension was cut into small pieces using #15 sterile scalpel blade, The resulting collagen fragments were then introduced incrementally into the root canal and gently compacted using the same technique described previously for placement of the PRF scaffold Receives: Other: Collagen Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
changing in root length
Measured: 1 year
changing in periapical lesion size
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 posted3 Nov 2026
- Study start10 Jan 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revascularization of Immature Permenant TeethStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Mohamed Arb, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913880
- Sponsor's protocol ID
- #R-END-7-26-3283
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Regenerative Potential of Four Different Biological Scaffolds in Treatment of Non Vital Immature Permanent Maxillary Incisors (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07913880
- Acronym / sponsor ID
- #R-END-7-26-3283
- Keywords
- Blood clot, Collagen membrane, Cone beam computed tomography, Platelet rich fibrin, Platelet rich plasma, Scaffold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 3 Nov 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.
the study concern with the patients who loss the vitality of their teeth before completion of root development and apply new treatment approaches to restore their vitality through different scaffolds applied in inside the root canal and allow growth completion of their immature root
Detailed description
the study assess the regenerative potential of four different biological scaffolds Blood Clot, Platelet rich plasma, Platelet rich fibrin and Collagen membrane as a new treatment modality for non-vital immature permanent incisors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Other: Blood ClotFor Blood Clot scaffold group, intracanal bleeding was intentionally induced by gently extending a sterile #40 stainless-steel K-file 1-2 mm beyond the apical foramen into the periapical tissues. Bleeding was allowed to reach at least 3 mm below the level of the CEJ, any excess blood above the CEJ coronally was removed with a suitable size of sterile paper points. After waiting nearly 10 minutes, the integrity of the newly formed clot was detected using a suitable sterile paper point |
| Group II | Active comparator | Other: Platelet Rich PlasmaFor PRP group, 5 mL of peripheral venous blood was obtained from the antecubital vein of each patient by venipuncture and collected into a 10 mL sterile glass tube containing acid citrate dextrose as an anticoagulant. The blood sample was initially centrifuged at 2400 rpm for 10 minutes to separate PRP and platelet-poor plasma (PPP) from the erythrocyte fraction. Following the first centrifugation cycle, three distinct layers were observed within the tube.; a bottom red thick layer containing red blood cells, a central buffy lightly yellowish layer containing white blood cells and plasma cells, and a supernatant turbid liquid layer which is acellular plasma. Supernatant layer (PRP + PPP) was carefully transferred to a sterile tube and subjected to a second centrifugation at 3600 rpm for 15 minutes to further separate the PRP from the PPP. After the second centrifugation cycle, PRP precipitated at the bottom of the tube as light yellowish slimy viscous substance which was retri |
| Group III | Active comparator | Other: Platelet Rich FibrinFor PRF group, 5 mL of the own venous blood was collected from the patient arm then was placed in a sterile tube without anticoagulant and centrifuged immediately at 3000 rpm for 10 minutes using a centrifuge machine . Three layers were formed inside each tube: a base layer containing erythrocytes, an intermediate layer of PRF clot, and a surface layer of acellular plasma. The PRF clot was removed from the test tube with sterile cotton plier and then put on a sterile gauze then cleared from the base erythrocyte layer using sterile scissor. The freshly prepared PRF clot was compressed between two sterile gauze pieces to form a membrane. The freshly prepared PRF membrane was sectioned into small fragments using sterile #15 scalpel blade and was placed incrementally inside root canal till the full WL length and nearly up to 3 mm below the level of the CEJ. A sterile hand plugger of appropriate size, adjusted to a length 2-3 mm shorter than the WL, was used to facilitate controlled place |
| Group IV | Active comparator | Other: Collagen MembraneThe collagen membrane scaffold, supplied in a 15 × 20 mm dimension was cut into small pieces using #15 sterile scalpel blade, The resulting collagen fragments were then introduced incrementally into the root canal and gently compacted using the same technique described previously for placement of the PRF scaffold |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The inclusion criteria comprised medically healthy patients with clinical findings consistent with pulpal necrosis, with or without an associated periapical lesion, and radiographic evidence of incomplete root development, defined by an apical diameter >1 mm
Key exclusion criteria (1 listed)
- Teeth were excluded if they exhibited a vital pulp and/or complete root maturation, were non-restorable, demonstrated radiographic evidence of root fracture, or if the patient had allergy to any medication or material required for the treatment protocol. Teeth associated with periodontal probing depths >4 mm were also excluded
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 |
|---|---|---|
| Blood Clotregenerative endodontic treatment using blood clot as scaffold | Other | Group I |
| Platelet Rich Plasmaregenerative endodontic treatment using platelet rich plasma as scaffold | Other | Group II |
| Platelet Rich Fibrinregenerative endodontic treatment using platelet rich fibrin as scaffold | Other | Group III |
| Collagen Membraneregenerative endodontic treatment using collagen membrane as scaffold | Other | Group IV |
Primary outcome
changing in root length
Time frame: 1 year
changing in periapical lesion size
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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The Present Study Was Conducted to Evaluate Bioceramic Root Repair Material Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.
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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 Blood Clot, Platelet Rich Plasma and Platelet Rich Fibrin in people with Revascularization of Immature Permenant Teeth, run by Tanta University 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 1 inclusion and 1 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 3 Nov 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?
changing in root length (time frame: 1 year). The study lists 2 primary outcomes in all. 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 3 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.