Regenerative Ability of Immature Necrotic Permanent Teeth Using Different Scaffolds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2024-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to compare effect of different scaffolds on the regenerative potential of young permanent immature teeth with necrotic pulp. The main question it aims to answer is:

is there difference in regenerative potential using Hyaluronic acid and platelets rich fibrin as scaffolds in permanent immature teeth with necrotic pulp? participants will undergo regeneration protocol including hyaluronic acid and platelets rich fibrin as scaffolds Researchers will compare \[hyaluronic acid , platelets rich fibrin , and no scaffold \] to see the regenerative potential

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical and Radiographic Outcome of Regeneration in Immature Permanent Human Teeth Using a New Scaffold

NCT06812351

Randomized Clinical Trial

COMPLETED PHASE1

Evaluation of Platelet-rich Fibrin for Revascularization of Immature Permanent Teeth Versus Standard Apexification

NCT06693349

To Evaluate the Clinical and Radiographic Effect of Platelet-rich Fibrin in Treatment of Necrotic Permanent Teeth with Open Apices

COMPLETED PHASE3

Effect of Different NanoScaffolds on Pulp Regeneration in Non-Vital Immature Permanent Teeth (Randomized Clinical Trial)

NCT07121348

Necrotic Immature Permanent Incisors

ACTIVE_NOT_RECRUITING NA

Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth

NCT04390854

Pulp Necroses

COMPLETED PHASE2

Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant

NCT04298294

Bone Loss

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will be conducted on 30 maxillary anterior teeth with open apex; with 10 maxillary anterior teeth with open apex in each group (n=10). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. single blinding will be maintained in this study as the Outcomes Assessor and the patients will not be aware of their group/used scaffold Group (I) control group with no scaffold used. Group (II) using platelets rich fibrin ( PRF) as a scaffold. Group (III) using hyaluronic acid (HYA) as a scaffold.

Procedural steps:

1st visit

1.Patients will be given anesthesia with vasoconstrictor . rubber dam isolation and access will be done 2. gentle irrigation with 1.5-3% sodium hypochlorite (NaOCl) (20ml/5 mins) using needle with closed end and side-vents with needle placed 1mm from apex will be done 3.then, irrigation will be done with saline or 17% Ethylenediaminetetraacetic acid (EDTA) (20 mL/canal, 5 min) 4. The canal space will be dried using sterile paper points 5.1ml of calcium hydroxide (metapaste) will be delivered into canal space 6.Sterile cotton pellet will be inserted and access cavity will be sealed using 3-4mm of temporary restoration (Coltosol F; Coltene Whaledent, Altstatten, Switzerland) for 3 weeks.

2nd visit

1. Final visit for three groups will be scheduled when tooth is asymptomatic with no signs of discharge.
2. In case of persistent infection one or more visits will be scheduled for discharge and disinfection.
3. patient will be anesthetized using 3% mepivacaine without vasoconstrictor, proper isolation will be done, the temporary restoration and cotton pellet will be removed.
4. Canal will be irrigated using 17% EDTA (20ml/5mins).
5. Canals will be dried using sterile paper points.
6. In group (I) A sterile hand file size #50 will be used sharp strokes 2 mm beyond apex into the periapical tissue until bleeding is evident in cervical portion of canal In group (II) For the PRF preparation, 10Ml of the patient's whole blood will be collected in sterile tubes from the cubital vein. The tubes will be centrifuged for 10 minutes with a speed of 3000 rpm .

Inside each test tube three layers will be formed: a base layer containing erythrocytes, an intermediate layer of PRF clot, and a surface layer of acellular plasma. The PRF clot will be separated from the other layers and then compressed in a PRF box (Intra-Lock International).

The compressed PRF membrane will be rolled over itself to allow its implantation into the canal .

The PRF membrane will be inserted inside the root canal and condensed apically with an endodontic hand plugger.

In group (III)A sterile hand file size #50 will be used sharp strokes 2 mm beyond apex into the periapical tissue until bleeding is evident in cervical portion of canal then, hyaluronic acid hydrogel will be inserted inside the canal
7. MTA plug orifice plug as a capping material will be used to seal canal orifice.
8. 3-4 mm layer of glass ionomer (e.g. Fuji IX™, GC America, Alsip, IL) will be flowed gently over the capping material and light-cured for 40 s to seal the access cavity.
9. A postoperative standardized periapical radiograph will be taken for baseline records
10. After treatment is done patient will be recalled for follow-up every three months for one year.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Regeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

no scaffold

initiate bleeding using hand files size beyond apex with sharp strokes

Group Type ACTIVE_COMPARATOR

no scaffold

Intervention Type PROCEDURE

initiate bleeding using hand files size beyond apex with sharp strokes with no PRF or hyaluronic acid placed

platelets rich fibrin

PRF is used as Scaffold by placing the compressed PRF membrane into canal

Group Type EXPERIMENTAL

Platelet rich fibrin

Intervention Type PROCEDURE

PRF membrane is placed as a scaffold inside the canal with no hyaluronic acid

hyaluronic acid

hyaluronic acid will be delivered by syringe into canal

Group Type EXPERIMENTAL

hyaluronic acid

Intervention Type PROCEDURE

hyaluronic acid gel is placed as a scaffold inside the canal with no PRF

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Platelet rich fibrin

PRF membrane is placed as a scaffold inside the canal with no hyaluronic acid

Intervention Type PROCEDURE

hyaluronic acid

hyaluronic acid gel is placed as a scaffold inside the canal with no PRF

Intervention Type PROCEDURE

no scaffold

initiate bleeding using hand files size beyond apex with sharp strokes with no PRF or hyaluronic acid placed

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with age range from 9-20 years with no sex predilection. Systemically healthy patients.
* Non-vital maxillary anterior presenting with or without signs and/or symptoms of periapical pathology.
* No mobility.
* Pocket depth less than 3 mm.