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Completed

NCT Number: NCT06437197

Evaluation of Using Platelet-Rich Fibrin in Adult Pulpotomy

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.

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Key information

Conditions

Irreversible Pulpitis

Age range

25 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, Al-Azhar university

Cairo, 11651, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulpotomy

Procedure

Removal of the coronal pulp chamber in an adult teeth

Other names: Pulp amputation

Primary outcomes

  1. 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

  1. 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).

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2024
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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