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

NCT06438523 | Recruiting

• 1 other identifier: 29
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (1)

• pain assessment

  Pain assessment using numerical rate scale

  6,12,24,72hours and 7 days postoperative

Secondary Outcomes (1)

• Clinical and radiographic success

  1,3,6,9and 12 months

Study Arms (3)

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

EXPERIMENTAL

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.

Procedure: PULPOTOMY OF MATURE PERMENANT TEETH

A-prf mixed with nano chitosan

EXPERIMENTAL

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

Procedure: PULPOTOMY OF MATURE PERMENANT TEETH

chitosan

EXPERIMENTAL

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

Procedure: PULPOTOMY OF MATURE PERMENANT TEETH

Interventions

PULPOTOMY OF MATURE PERMENANT TEETH 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; Advanced Platelet rich fibrin,A-prf,A-PRF scaffold; chitosan

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future university

Cairo, Fifth Settlement, 11813, Egypt

RECRUITING

Study Officials

• wael H Kamel, Prof.

  Future University in Egypt

  STUDY DIRECTOR

• Hani s sadek, Prof.

  Future University in Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mai S abdelwahed, Bachelor

CONTACT

01068609957; memo_141997@HOTMAIL.COM

Hala s abdelwahed, student

CONTACT

01068609957; MSNAHLARIAD@HOTMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 3, 2024
• Study Start: September 2, 2023
• Primary Completion: May 2, 2025
• Study Completion: September 2, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)