Assessment of I-PRF Versus Nano MTA Combined with I-PRF Scaffold in Vital Pulp Therapy in Mature Mandibular First Molars

Not Applicable

Recruiting

• Conditions: Pulpotomy

• Registration Number: NCT06640205
• Lead Sponsor: Future University in Egypt

Brief Summary

Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF in pulpotomy in mature Mandibular First Molars

Detailed Description

Clinical and Radiographic Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: "Randomized Controlled Trial"

Study Timeline

• Study Start: 2023-09-03
• Study First Submitted: 2024-08-16
• Primary Completion: 2024-09-02
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Study Completion: 2025-09-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 51

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.
  • The tooth is restorable
  • 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 periapical lesions or infections.
  • Pregnant females.
  • Patients with fistula or swelling
  • Patients with necrotic pulp.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post operative pain assessments	6 hours post operative , 12 hours post operative , 24h (one day) post operative , 72h (3 days ) post operative and 7 days (one week) post operative	Pain assessments were made postoperatively with numerical rate scale. The scale includes scores from 0 to 10 where 0 indicates no pain , scores 1 to 3 indicates mild pain , scores 4 to 6 indicates moderate and scores 7 to 10 indicates severe pain.

Secondary Outcome Measures

Name	Time	Method
Clinical and radiographic success	1 month post operative ,3 months clinical and radiograph ,6 months clinical and radiograph ,9 months clinical and radiograph and 12 months clinical and radiograph.	Clinically success : this includes that the tooth must be symptoms free ( No pain on percussion , no pain on biting and no pain with cold and hot ) . Also the tooth must not has any signs of failure as appearance of sinus tract or fistula during the follow up periods.; Radiographic success : this includes that the tooth did not develop a periapical radiolucency as periapical periodontitis .; Any deviation from the previous success criteria ( as clinical or radiographic ) considered as failure and the tooth will be shifted to root canal treatment.

Trial Locations

Locations (1)

Future university in egypt; 🇪🇬 Cairo, Egypt