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Clinical Trials/NCT06437197
NCT06437197CompletedNot Applicable

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

Al-Azhar University1 site in 1 country20 target enrollmentStarted: March 12, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Radiographic changes in periapical area using periapical radiographs.

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
25 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Immature teeth.
  • •Non-restorable teeth.
  • •Non-vital Teeth.
  • •Uncontrolled pulpal bleeding.
  • •Periodontally affected teeth.

Arms & Interventions

Hydraulic Calcium Silicate Cement

Active Comparator

Pulpotomy of adult teeth using Hydraulic Calcium Silicate Cement.

Intervention: Pulpotomy (Procedure)

platelet rich fibrin (PRF)

Experimental

Pulpotomy of adult teeth using platelet Rich fibrin.

Intervention: Pulpotomy (Procedure)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Postoperative pain(Immediately, 24, 48, 72 hours and 7 days.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Ibrahim Ahmed Qandeel

Demonstrator of Endodontics, Faculty of Dental Medicine

Al-Azhar University

Study Sites (1)

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