Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices

Overview

Clinical, Radiographic and pain assessment of Vital pulp treatment in patients suffering from irreversible pulpitis in mature permanent molars. Total pulpotomy is investigated using I-prf only vs I-prf mixed with Nano-bioactive glass.

Full Title of Study: “Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices: A Triple Blinded “Randomized Controlled Trial””

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2024

Interventions

  • Procedure: Total pulpotomy with I-prf mixed with Nano-bioactive glass
    • Total pulpotomy is done in mature permanent molars followed by I-prf mixed with Nano-Bioactive glass application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration

Arms, Groups and Cohorts

  • Other: Total pulpotomy with I-PRF only
    • Total pulpotomy is done in mature permanent molars followed by I-prf application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration

Clinical Trial Outcome Measures

Primary Measures

  • Clinical , Radiographic and Success rate
    • Time Frame: 6 month follow up
    • Presence or absence of clinical signs and symptoms + Radiographic periapical assessment + success rate based on Radiographic findings

Secondary Measures

  • Pain intensity
    • Time Frame: Within the first 24 hrs upto the 7th day
    • VAS used to record daily pain intensity

Participating in This Clinical Trial

Inclusion Criteria

  • Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved. – 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 apices – 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.

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 32 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Noor Mohammed Kamal Eldeen Ahmed Mohmammed Sayed, Resident of Endodontics – Cairo University
  • Overall Official(s)
    • Geraldine Ahmed, Study Director, Vice Dean of Faculty of Dentistry Cairo University
    • Ahmed S. Elsheshtawy, Study Chair, Lecturer of Endodontics
    • Ayah Abdolwahab, Study Chair, Lecturer of Biomaterials
    • Noor K. Sayed, Principal Investigator, Resident of Endodontics
  • Overall Contact(s)
    • Noor K. Sayed, 00201121818177, noor.kamal@dentistry.cu.edu.eg

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