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

Pulpitis - Irreversible Clinical Trial

Official title:

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 Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438523
• Other study ID #: 29
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2023
• Est. completion date: September 2, 2025

Study information

• Verified date: May 2024
• Source: Future University in Egypt
• Contact: mai S abdelwahed, Bachelor
• Phone: 01068609957
• Email: memo_141997[@]HOTMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2, 2025
• Est. primary completion date: May 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

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

Locations

Country	Name	City	State
Egypt	Future university	Cairo	Fifth Settlement

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain assessment	Pain assessment using numerical rate scale	6,12,24,72hours and 7 days postoperative
Secondary	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