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

A-prf,Nanochitosan Combined With A-prf Scaffold Compared to Chitosan in Vital Pulp Therapy for Symptomatic Irreversible Pulpitis of Mature Permanent Mandibular First Molar Teeth .Randomized Controlled Trials

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

Study Overview

• Status: Recruiting
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Procedure: PULPOTOMY OF MATURE PERMENANT TEETH

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mai S abdelwahed, Bachelor; Phone Number: 01010604352 01068609957; Email: memo_141997@HOTMAIL.COM
• Study Contact Backup: Name: Hala s abdelwahed, student; Phone Number: 01010604352 01068609957; Email: MSNAHLARIAD@HOTMAIL.COM

Study Locations

• Egypt
  • Fifth Settlement
    • Cairo, Fifth Settlement, Egypt, 11813
      • Recruiting
      • Future university
      • Contact: Mai Sheriff Abdelwahed, Researcher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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
Experimental: 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	Procedure: 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
Experimental: 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	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain assessment	Pain assessment using numerical rate scale	6,12,24,72hours and 7 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and radiographic success	It includes clinical and radiographic success if either of them failed the case will considered failed. Clinical failure :signs and symptoms of inflammation or infection Radiograph success and failure based on periapical index	1,3,6,9and 12 months

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Investigators: Study Director: wael H Kamel, Prof., Future University in Egypt; Principal Investigator: Hani s sadek, Prof., Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2023
• Primary Completion (Estimated): May 2, 2025
• Study Completion (Estimated): September 2, 2025

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: 29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No