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

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"

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

Study Overview

• Status: Recruiting
• Conditions: Pulpotomy
• Intervention / Treatment: Procedure: pulpotomy

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 Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: abdelrahman Mo Omar, Master; Phone Number: 002 00201000424892; Email: Abdulrahmanomar232@gmail.com
• Study Contact Backup: Name: Mai Sh abdelwahed, Master; Phone Number: 002 01068609957; Email: Memo_141967@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11835
    • Recruiting
    • Future university in egypt
    • Contact: Abdelrahman Mo omar, Master; Phone Number: 002 01000424892; Email: Abdelrahmanomar232@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MTA Pulpotomy; using MTA as pulpotomy capping agent in mature permanent teeth	Procedure: pulpotomy; Removal of coronal pulp tissue and then placing pulpotomy agent; Other Names: vital pulp therapy; full pulpotomy
Experimental: I-PRF pulpotomy; using I-PRF as pulpotomy capping agent in mature permanent teeth	Procedure: pulpotomy; Removal of coronal pulp tissue and then placing pulpotomy agent; Other Names: vital pulp therapy; full pulpotomy
Experimental: I-PRF combined with Nano MTA pulpotomy; using nano MTA mixed with I-prf as pulpotomy capping agent in mature permanent teeth	Procedure: pulpotomy; Removal of coronal pulp tissue and then placing pulpotomy agent; Other Names: vital pulp therapy; full pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain assessments	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and radiographic success	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.	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.

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Investigators: Study Chair: Abdelrahman Mo Omar, Master, Future university in egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2023
• Primary Completion (Actual): September 2, 2024
• Study Completion (Estimated): September 2, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: (32)/8-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No