Evaluation of Using Platelet-Rich Fibrin in Adult Pulpotomy

Not Applicable

Completed

• Conditions: Irreversible Pulpitis
• Interventions: Procedure: Pulpotomy

• Registration Number: NCT06437197
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-09
• Study Start: 2023-03-12
• Primary Completion: 2024-03-18
• Study Completion: 2024-03-23
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-26
• Last Update Submitted: 2024-05-26
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydraulic Calcium Silicate Cement	Pulpotomy	Pulpotomy of adult teeth using Hydraulic Calcium Silicate Cement.
platelet rich fibrin (PRF)	Pulpotomy	Pulpotomy of adult teeth using platelet Rich fibrin.

Primary Outcome Measures

Name	Time	Method
Radiographic changes in periapical area using periapical radiographs.	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 Outcome Measures

Name	Time	Method
Postoperative pain	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).

Trial Locations

Locations (1)

Faculty of Dental Medicine, Al-Azhar university; 🇪🇬 Cairo, Egypt