The Use of Platelet-Rich Fibrin in Partial Pulpotomy Procedure

February 10, 2022 updated by: Damascus University

Dental Pulp Response to The Combination Use of Platelet-Rich Fibrin and Mineral Trioxide Aggregate in Partial Pulpotomy of Sound Human Premolars: A Randomized Controlled Trial

The aim of this study is to evaluate the clinical and histological pulp responses when MTA and a combined of MTA/PRF is used as pulp-capping agents after partial pulpotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Partial pulpotomy is generally considered as the treatment of choice for immature permanent teeth with reversible injury. Mineral trioxide aggregate (MTA) is a gold standard material as pulp capping agent in term of vital pulp therapy. Despite many advantages, MTA has a long setting time, little biological inductivity, difficult handling characteristics and high cost.

An essential aspect of tooth tissue engineering is the identification of a suitable scaffold to support cell growth and tissue regeneration. Platelet-Rich Fibrin (PRF) is a second generation platelet concentrate. It is strictly autologous and helps to release the growth factors necessary for the regeneration of dentin pulp complex. Therefore, PRF seems to be a suitable scaffold in vital pulp therapy.

Study sample, 24 intact maxillary or mandibular premolars which will be extracted for orthodontic reasons in 12 healthy volunteers. The sample will be chosen from the patients who are coming to the Orthodontic department in the Faculty of dentistry - Damascus university.

This study will be performed as split mouth study. For each selected patient, one premolar will be randomly allocated to MTA only and the other to combined MTA/PRF by a toss of coin. The main operator will give each patient a numerical code (from 1 to 12) whilst the teeth will have an alphabetical coding (e.g. For the patient coded as 1, premolar with MTA will be coded as 1-a, the other premolar with MTA/PRF will be coded as 1-b). In all patient documents, the teeth will be labeled in the same way so that the clinical examiner and a pathologist will be blinded to the capping technique used for each tooth whilst the main operator who perform a pulpotomy will know which technique is used for each premolar.

Postoperative pain and sensitivity to thermal stimuli will be analyzed after the treatment between two sides.

After 8 weeks, the teeth will be extracted and histologically evaluated in terms of inflammation, dentin bridge formation and its appearance.

Study Type

Interventional

Enrollment (Actual)

12

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

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Endodontics and Operative Dentistry, University of Damascus Dental School, Damascus, Syria

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

12 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. No systemic disease and no medication consumption.
  2. Participants, with healthy first premolars in either of the jaws, assigned for orthodontic extraction (scheduled extraction of the maxillary/mandibular premolars).
  3. The premolar teeth needed to be fully erupted.
  4. The premolar teeth needed to respond within the normal range to cold testing and heat testing.
  5. The patients' parents had read, signed and thoroughly understood the informed consent.

Exclusion Criteria:

  1. Presence of systematic disease and medication consumption of any type.
  2. Anti-inflammatory medicine taken before and during the time of study.
  3. Premolars with caries, restoration or any abnormality on periapical radiographs.
  4. If the premolar teeth were not fully erupted.
  5. If the premolar teeth revealed a lingering pain (a pain sensation that had the tendency to linger as a dull ache after the stimulus had been removed upon cold testing and heat testing).

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
Active Comparator: Mineral Trioxide Aggregate (MTA)
A standardized partial pulpotomy procedure will be performed after administration of local anesthesia. The exposed pulp tissues will be directly capped with a 3mm of MTA (Pro Root MTA) layer.
Procedure: partial pulpotomy
Removal of a small portion of coronal pulp tissue after exposure, followed by application of a biomaterial directly onto the remaining pulp tissue prior to placement of a permanent restoration.
Experimental: MTA with platelet rich fibrin (PRF).
A standardized partial pulpotomy procedure will be performed after administration of local anesthesia. The PRF membrane obtained after centrifugation of the patient's own blood is going to be placed over the exposed pulp. Then, a 3mm of MTA (Pro Root MTA) will be placed over the PRF membrane.
Procedure: partial pulpotomy
Removal of a small portion of coronal pulp tissue after exposure, followed by application of a biomaterial directly onto the remaining pulp tissue prior to placement of a permanent restoration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thickness of dentin bridge
Time Frame: eight weeks after intervention

This outcome will be evaluated by means of light microscopy linked to the camera with magnification of 4X, 20X, 40X and 100X. A periodontal probe will be placed over a histologic section to serve as a scale before image acquisition. The thickness of dentin bridge will be measured at the thickest, thinnest, and midmost point areas of the bridge. The average of the 3 values will be calculated. Each histologic section will be scored from 1-4, with 1 representing the most desired result and 4 representing the least desired result as follows:

  1. Thickness of dentin bridge is more than 0.25mm
  2. Thickness of dentin bridge is less than 0.25mm but more than 0.1mm.
  3. Thickness of dentin bridge is less than 0.1mm
  4. Partial or absent bridge.
eight weeks after intervention
Appearance of dentin bridge
Time Frame: eight weeks after intervention

This outcome will be evaluated by means of light microscopy linked to the camera with magnification of 4X, 20X, 40X and 100X. Each histologic section will be scored from 1-4, with 1 representing the most desired result and 4 representing the least desired result as follows:

  1. Dentin that displays a tubular structure or dentin associated with irregular hard tissue that is not exhibit the characteristic tubular structure, but resemble bony tissue and often display cellular inclusions.
  2. Only irregular hard tissue deposition.
  3. Only a thin layer of hard tissue deposition.
  4. No hard tissue deposition
eight weeks after intervention
Intensity of Pulp Inflammation
Time Frame: eight weeks after intervention

This outcome will be evaluated by means of light microscopy linked to the camera with magnification of 4X, 20X, 40X and 100X. Each histologic section will be scored from 1-4, with 1 representing the most desired result and 4 representing the least desired result as follows:

  1. Absent or very few inflammatory cells
  2. Mild: defined as an average of inflammatory cells is less than 10 cells.
  3. Moderate: defined as an average of inflammatory cells is more than10 cells but less than 25 cells.
  4. Severe: defined as an average of inflammatory cells is more than 25 cells.
eight weeks after intervention
Extension of Pulp Inflammation
Time Frame: eight weeks after intervention

This outcome will be evaluated by means of light microscopy linked to the camera with magnification of 4X, 20X, 40X and 100X. Each histologic section will be scored from 1-4, with 1 representing the most desired result and 4 representing the least desired result as follows:

  1. Absent
  2. Mild: defined as inflammatory cells only next to pulp exposure site
  3. Moderate: defined as inflammatory cells observed in part of coronal pulp (in one-third or more of the coronal pulp or in the middle pulp)
  4. Severe: defined as all coronal pulp is infiltrated
eight weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain: VAS
Time Frame: using a 0 to 10-cm visual analog scale (VAS) scale, pain will be record every 24 hours until the seventh day after intervention
Patients or their parents will be asked to rate their pain by placing a mark on the line corresponding to their current level of postoperative pain. Pain on the VAS will be further categorized as no pain (0), or mild (1-3), moderate (4-6), or severe (7-10) pain.
using a 0 to 10-cm visual analog scale (VAS) scale, pain will be record every 24 hours until the seventh day after intervention
Sensitivity to thermal stimuli
Time Frame: this outcome will be examined every week until the eighth week after intervention

Cold testing will be performed with a refrigerant spray that apply to the tooth on a large cotton pellet. The responses will be further categorized as:

  • Normal response: patient's report that a sensation is felt but disappears immediately upon removal of the thermal stimulus.
  • Abnormal response: lingering or intensification of a painful sensation after the stimulus is removed, or an immediate, excruciatingly painful sensation as soon as the stimulus is placed on the tooth.
  • Lack of response to the stimulus
this outcome will be examined every week until the eighth week after intervention

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Study Director: Rami Zenaldeen, DDS MSc, PhD student at the Endodontic and Operative Dentistry Department, University of Damascus Dental School, Damascus, Syrian Arab Republic
  • Principal Investigator: Ossama Aljabban, DDS MSc PhD, Professor at Endodontic and Operative Dentistry Department, University of Damascus Dental School, Damascus, Syrian Arab Republic
  • Study Director: Mohammad Y Hajeer, DDS MSc PhD, Associate Professor at Department of Orthodontics, University of Damascus Dental School, Damascus, Syrian Arab Republic

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)

May 1, 2020

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

December 23, 2021

Study Registration Dates

First Submitted

March 29, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-OperDent-01-2020

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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