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CompletedNCT07913880Updated Nov 3, 2026

Revascularization of Immature Teeth With Our Different Scaffolds

An interventional study of Blood Clot and Platelet Rich Plasma in Revascularization of Immature Permenant Teeth, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Jan 2024, registered Oct 2026).
Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Revascularization of Immature Permenant Teeth

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Keywords

  • Blood clot, Collagen membrane, Cone beam computed tomography, Platelet rich fibrin, Platelet rich plasma, Scaffold
03

In context

Thrombosis

955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.

This study's enrollment of 40 is below the median of 83 across 530 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Group I

    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

    Other: Blood Clot

  • Active comparator
    Group II

    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

    Other: Platelet Rich Plasma

  • Active comparator
    Group III

    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

    Other: Platelet Rich Fibrin

  • Active comparator
    Group IV

    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

    Other: Collagen Membrane

Interventions

  • OtherBlood Clot

    regenerative endodontic treatment using blood clot as scaffold

  • OtherPlatelet Rich Plasma

    regenerative endodontic treatment using platelet rich plasma as scaffold

  • OtherPlatelet Rich Fibrin

    regenerative endodontic treatment using platelet rich fibrin as scaffold

  • OtherCollagen Membrane

    regenerative endodontic treatment using collagen membrane as scaffold

06

What researchers measure

Primary outcomes

  1. changing in root length

    Time frame: 1 year

  2. changing in periapical lesion size

    Time frame: 1 year

07

Study locations

1 site
  • Hanan arb
    Tanta, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Jan 2025, 12 months.

Of 108 non-industry interventional studies with no phase under Thrombosis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's 12 months is below that.

Counting every sponsor, half of 115 studies reached it within 24 months; a quarter within 9 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 3, 2026
StartActual
Jan 10, 2024
Primary completionActual
Jan 10, 2025
CompletionActual
Jan 10, 2026
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07913880
Lead sponsor
Tanta University
Responsible party
Hanan Mohamed Arb (lecturer of endodontics, Tanta University) — Principal investigator
First posted
Nov 3, 2026
Start date
Jan 10, 2024
Primary completion
Jan 10, 2025
Completion
Jan 10, 2026
Last update
Nov 3, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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