Clinical trial NCT06438523: A-prf,Nanochitosan Combined With A-prf Compared to Chitosan for Symptomatic Irreversible Pulpitis of Mature Teeth
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulpitis - Irreversible
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: pain assessment
timeFrame: 6,12,24,72hours and 7 days postoperative
Secondary outcomes:
measure: Clinical and radiographic success
timeFrame: 1,3,6,9and 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future university
state: Fifth Settlement
Study officials:
affiliation: Future University in Egypt
name: wael H Kamel, Prof.
role: STUDY_DIRECTOR
affiliation: Future University in Egypt
name: Hani s sadek, Prof.
role: PRINCIPAL_INVESTIGATOR
References: