A-prf,Nanochitosan Combined With A-prf Compared to Chitosan for Symptomatic Irreversible Pulpitis of Mature Teeth

NCT ID: NCT06438523

Last Updated: 2024-06-03

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-02

Study Completion Date

2025-09-02

Brief Summary

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Clinical and radiographic assessment of A-prf,A-prf combined with nanochitosan compared to chitosan for symptomatic irreversible pulpits in lower permanent first molar

Detailed Description

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3 groups are allocated using : Aprf Aprf combined with nanochitosan Chitosan

Each group will be subjected to tests:

Tooth sensibility via EPT (electrical pulp tester)and thermal test Radiolucency in digital radiograph Pain in NRS(6-12-24-72h)for 1 week

Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention:

Intervention 1 : Vital pulp therapy using A-PRF as capping material. Intervention 2 : Vital pulp therapy using A-PRF mixed with Nano-Chitosan as capping material.

Control/Comparator:

Vital pulp therapy using Chitosan as capping material.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Advanced Platelet rich fibrin,A-prf,A-PRF scaffold

A-PRF will be prepared according to Choukroun's technique by drawing whole blood from the median cubital vein into a 10 ml plain plastic test tubes (non-citrated) without the addition of an anticoagulant reagent .

To prevent the blood from coagulating, it will be centrifuged immediately using a table top centrifuge at 1500 rpm for 14 minute.

Group Type EXPERIMENTAL

PULPOTOMY OF MATURE PERMENANT TEETH

Intervention Type PROCEDURE

Removal of coronal pulp and expose the orifices to apply the materials with aim to preserve vitality of remaining pulp

A-prf mixed with nano chitosan

A-PRF will be prepared according to Choukroun's technique by drawing whole blood from the median cubital vein into a 10 ml plain plastic test tubes (non-citrated) without the addition of an anticoagulant reagent .

To prevent the blood from coagulating, it will be centrifuged immediately using a table top centrifuge at 1500 rpm for 14 minute then mixed with nanochitosan

Group Type EXPERIMENTAL

PULPOTOMY OF MATURE PERMENANT TEETH

Intervention Type PROCEDURE

Removal of coronal pulp and expose the orifices to apply the materials with aim to preserve vitality of remaining pulp

chitosan

he access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 1 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile excavator should be used to remove the pulp tissue to the level of the radicular/root canal orifices then chitosan will be applied

Group Type EXPERIMENTAL

PULPOTOMY OF MATURE PERMENANT TEETH

Intervention Type PROCEDURE

Removal of coronal pulp and expose the orifices to apply the materials with aim to preserve vitality of remaining pulp

Interventions

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PULPOTOMY OF MATURE PERMENANT TEETH

Removal of coronal pulp and expose the orifices to apply the materials with aim to preserve vitality of remaining pulp

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.

* Patients of either gender aged from 15-30.
* Tooth should give positive response to cold test.
* Haemostasias should be achieved after total pulpotomy.
* The tooth is restorable and free from advanced periodontal disease, cracks and splits.
* Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
* Patients who will agree to the consent and will commit to follow-up period.
* Patients with mature root.
* Patients with no internal or external resorption and no periapical lesions.
* Soft tissues around the tooth are normal with no swelling or sinus tract.

Exclusion Criteria

* Patients with immature roots.

* Haemostasias after 10 minutes can not be controlled after total pulpotomy
* Patients with any systemic disease that may affect normal healing.
* Patients with periapical lesions or infections.
* Pregnant females.
* Patients who could/would not participate in a 6 months follow-up.
* Patients with fistula or swelling
* Patients with necrotic pulp.
* Patients with old age.
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Mai Sherif

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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wael H Kamel, Prof.

Role: STUDY_DIRECTOR

Future University in Egypt

Hani s sadek, Prof.

Role: PRINCIPAL_INVESTIGATOR

Future University in Egypt

Locations

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Future university

Cairo, Fifth Settlement, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mai S abdelwahed, Bachelor

Role: CONTACT

01068609957 ext. 01010604352

Hala s abdelwahed, student

Role: CONTACT

01068609957 ext. 01010604352

Facility Contacts

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Mai Sheriff Abdelwahed, Researcher

Role: primary

Other Identifiers

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29

Identifier Type: -

Identifier Source: org_study_id

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