Evaluation of Using Platelet-Rich Fibrin in Adult Pulpotomy

May 26, 2024 updated by: Ahmed Ibrahim Ahmed Qandeel, Al-Azhar University

Clinical and Radiographic Evaluation of Platelets Rich Fibrin in Adult Pulpotomy: Randomized Clinical Trial

The goal of this interventional randomized clinical trial is to evaluate the use of platelet rich fibrin in full pulpotomy in mature adult teeth.

The main questions it aims to answer are:

  1. Does the use of platelet rich fibrin in complete pulpotomy in mature permanent teeth will raise the success rate of full pulpotomy of adult teeth?
  2. Does the use of cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs?

Participants will be asked to do the following:

  • Receive the pulpotomy treatment of their target tooth.
  • Record the pain score in the pain assessment chart.
  • Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target tooth. Researchers will evaluate the usage of platelet rich fibrin in performing the pulpotomy procedure of adult teeth and if cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Egypt
      • Cairo, Egypt, 11651
        • Faculty of Dental Medicine, Al-Azhar University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patient age: 25-35 years
  2. Mature permanent premolar teeth with two separate roots.
  3. Clinical diagnosis of irreversible pulpitis.
  4. Patients without existing medical condition.

Exclusion criteria:

  1. Immature teeth.
  2. Non-restorable teeth.
  3. Non-vital Teeth.
  4. Uncontrolled pulpal bleeding.
  5. Periodontally affected teeth.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hydraulic Calcium Silicate Cement
Pulpotomy of adult teeth using Hydraulic Calcium Silicate Cement.
Procedure: Pulpotomy
Removal of the coronal pulp chamber in an adult teeth
Other Names:
  • Pulp amputation
Experimental: platelet rich fibrin (PRF)
Pulpotomy of adult teeth using platelet Rich fibrin.
Procedure: Pulpotomy
Removal of the coronal pulp chamber in an adult teeth
Other Names:
  • Pulp amputation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic changes in periapical area using periapical radiographs.
Time Frame: 6 and 12 months.
The radiographic changes was evaluated using periapical radiographs. the outcome was measured using the periapical index scoring 1,2,3,4 or 5 with 1 indicating normal and 5 indicates severe periodontitis with exacerbating features.
6 and 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: Immediately, 24, 48, 72 hours and 7 days.
The postoperative pain was measured by modified modified Visual analog scale VAS which is is segmented into ten levels according to severity of pain, no pain (0), mild pain (1-3), moderate pain (4-6), or severe pain (7-10).
Immediately, 24, 48, 72 hours and 7 days.

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 12, 2023

Primary Completion (Actual)

March 18, 2024

Study Completion (Actual)

March 23, 2024

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

May 26, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 867/2992

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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