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

NCT06640205 | Recruiting

• 1 other identifier: (32)/8-2023
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulpotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (3)

MTA Pulpotomy

ACTIVE COMPARATOR

using MTA as pulpotomy capping agent in mature permanent teeth

Procedure: pulpotomy

I-PRF pulpotomy

EXPERIMENTAL

using I-PRF as pulpotomy capping agent in mature permanent teeth

Procedure: pulpotomy

I-PRF combined with Nano MTA pulpotomy

EXPERIMENTAL

using nano MTA mixed with I-prf as pulpotomy capping agent in mature permanent teeth

Procedure: pulpotomy

Interventions

pulpotomy PROCEDURE

Removal of coronal pulp tissue and then placing pulpotomy agent

Also known as: full pulpotomy, vital pulp therapy

I-PRF combined with Nano MTA pulpotomy; I-PRF pulpotomy; MTA Pulpotomy

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future university in egypt

Cairo, 11835, Egypt

RECRUITING

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Abdelrahman Mo Omar, Master

  Future University in Egypt

  STUDY CHAIR

Central Study Contacts

abdelrahman Mo Omar, Master

CONTACT

00201000424892; Abdulrahmanomar232@gmail.com

Mai Sh abdelwahed, Master

CONTACT

01068609957; Memo_141967@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: October 15, 2024
• Study Start: September 3, 2023
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)