Assessment of L-PRF, Nanohydroxyapatite Combined With L-PRF Using Pulpotomy in Mature Mandibular First Molars

September 25, 2024 updated by: Nada Ayman El-Sayed Ibraim, Future University in Egypt

Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite Material Combined With L-PRF Scaffold in Vital Pulp Therapy. Treatments in Mandibular First Molars With Closed Apices "Randomized Controlled Trial"

Clinical and Radiographic Assessment of L-PRF, Nanohydroxyapatite material combined with L-PRF scaffold in Vital pulp Therapy. Treatments in Mandibular First Molars with Closed Apices, Randomized Controlled Trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

pulpotomy by using 3 materials. The first group(control group ) uses hydroxyapatite material as a pulpotomy agent, and the second group uses L-PRF as a pulpotomy agent. the third group uses combined material (L-PRF = Nano hydroxyapatite )as a pulpotomy agent .. then assesses the clinical and radiographic result of the 2 interventions group with control group

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: toka A metwally, bachelor's
  • Phone Number: +02 01068681660

Study Locations

  • Egypt
    • New Cairo
      • Cairo, New Cairo, Egypt, 11835
        • Recruiting
        • Future University in Egypt
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

Patients should be free from any systemic disease. Patients of either gender aged from 15-30. Patients will agree to the consent and will commit to a follow-up period. Soft tissues around the tooth are normal with no swelling or sinus tract. The tooth is restorable tooth has signs and symptoms of irreversible pulpitis of the mature root The tooth doesn't contain any internal or external resorption or periapical lesions.

The tooth should give a positive response to the cold test.

Exclusion criteria:

Pregnant and lactating females. Patients with Mental disturbance. Patients who could/would not participate in a 6-month follow-up. A tooth with immature roots. Patients with necrotic pulp.• tooth with periapical lesions or infections. Soft tissue having fistula or swelling Homoeostasis after 10 minutes can not be controlled after total pulpotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hydroxyapatite
using hydroxyapatite as a pulpotomy agent and reviewing its clinical and radiographic performance compared to the other groups
Procedure: pulpotomy
removal of the coronal pulp tissue and preservation of the radicular portion to ensure continuation of growth and vitality of tooth structure
Other Names:
  • vital pulp therapy
Experimental: L-PRF
using L-PRF as a pulpotomy agent and assessing the clinical and radiographic result compared to other groups
Procedure: pulpotomy
removal of the coronal pulp tissue and preservation of the radicular portion to ensure continuation of growth and vitality of tooth structure
Other Names:
  • vital pulp therapy
Experimental: L-PRF combined with Nano-hydroxyapatite
using the combined material (nanohydroxyapatite mixed to L-PRF ) and assessing the clinical and radiographic result compared to other groups
Procedure: pulpotomy
removal of the coronal pulp tissue and preservation of the radicular portion to ensure continuation of growth and vitality of tooth structure
Other Names:
  • vital pulp therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative Pain assessment
Time Frame: 6, 12, 24, 72hours and 7 days after treatment
Pain evaluations were conducted preoperatively with numerical rating scale ( a verbal or writing determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain .
6, 12, 24, 72hours and 7 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentine bridge formation
Time Frame: 12 months post operative
evaluating the thickness of dentine bridge formed after the procedure by comparing immediate post operative CBCT with the one year follow up scans
12 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Investigators

  • Study Director: wael K hussein, professor, future

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (37)11-2023

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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