Using Nano Bioactive Glass with i-PRF for treating pulpitis in molars

Short Term Clinical and Radiographic Evaluation of Nano Bioactive Glass Combined With i-PRF Scaffold in Vital Pulp Treatments in Mature Permanent Mandibular Molars: A Triple Blinded "Randomized Controlled Trial"

This study is testing if using a special glass with a blood product can help treat painful tooth pulp better than just using the blood product alone in patients with severe tooth pain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 10 Years to 50 Years
• Sex: All
• Sponsor: Cairo University (other)
• Locations: 1 site (Cairo)
• Trial ID: NCT05902936 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of combining Nano Bioactive Glass (Nano-BAG) with injectable Platelet Rich Fibrin (i-PRF) as a pulpotomy material compared to using i-PRF alone in treating symptomatic irreversible pulpitis in mature permanent mandibular molars. Patients will be randomly assigned to receive either treatment, and outcomes will be assessed based on pain relief, maintenance of radicular pulp vitality, and dentin bridge formation. Both treatment groups will have their pulpotomy material sealed with a layer of premixed bioceramic putty. The study aims to determine if the combination of Nano-BAG and i-PRF offers superior results over i-PRF alone.

Who should consider this trial

Good fit: Ideal candidates are patients suffering from symptomatic irreversible pulpitis in mature permanent mandibular molars.

Not a fit: Patients with immature root apices or systemic diseases affecting healing may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the success rates of pulpotomy procedures in patients with irreversible pulpitis.

How similar studies have performed: While the combination of i-PRF and Nano-BAG is a novel approach, previous studies have shown promising results with i-PRF in dental treatments.

Eligibility criteria

Inclusion Criteria:

* • Patients suffering from symptomatic irreversible pulpitis.

  * Tooth should give positive response to cold test
  * Heamostatis should be achieved after complete pulpotomy
  * Diagnosis is irreversible pulpitis with/without apical periodontitis
  * The tooth is restorable and free from advanced periodontal disease
  * Tooth is free from cracks or splits
  * Patients should be free from any systemic disease that may affect normal healing and predictable outcomes.
  * Patients who will agree to the consent and will commit to follow-up period.
  * Patients with mature root (closed apices)
  * Teeth with no periapical lesion, resorption or widening.
  * Soft tissues around the tooth are normal with no swelling or sinus tract
  * Mandibular posterior teeth only will be involved.

Exclusion Criteria:

* • Patients with immature root apices.

  * Patients with any systemic disease that may affect normal healing.
  * Patients with periapical lesions or infections.
  * If heamostasis couldn't be achieved within 5-10 minutes
  * 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.
  * Badly destructed teeth
  * Teeth that are non-restorable
  * Teeth that require post and core build up

Where this trial is running

Cairo

• Faculty of oral and dental medicine - Cairo University — Cairo, Egypt (RECRUITING)

Study contacts

• Study coordinator: Geraldine Ahmed, Professor

Conditions: Pulpitis - Irreversible, Apical Periodontitis