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Completed

NCT Number: NCT04331964

The Use of Platelet-Rich Fibrin in Partial Pulpotomy Procedure

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.

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Key information

Conditions

Pulpitis Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endodontics and Operative Dentistry, University of Damascus Dental School, Damascus, Syria

Damascus, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Presence of systematic disease and medication consumption of any type.
  • Anti-inflammatory medicine taken before and during the time of study.
  • Premolars with caries, restoration or any abnormality on periapical radiographs.
  • If the premolar teeth were not fully erupted.
  • 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).

Treatment and study plan

Partial pulpotomy

Procedure

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.

Primary outcomes

  1. 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:

    • Thickness of dentin bridge is more than 0.25mm
    • Thickness of dentin bridge is less than 0.25mm but more than 0.1mm.
    • Thickness of dentin bridge is less than 0.1mm
    • Partial or absent bridge.

  2. 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:

    • 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.
    • Only irregular hard tissue deposition.
    • Only a thin layer of hard tissue deposition.
    • No hard tissue deposition

  3. 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:

    • Absent or very few inflammatory cells
    • Mild: defined as an average of inflammatory cells is less than 10 cells.
    • Moderate: defined as an average of inflammatory cells is more than10 cells but less than 25 cells.
    • Severe: defined as an average of inflammatory cells is more than 25 cells.

  4. 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:

    • Absent
    • Mild: defined as inflammatory cells only next to pulp exposure site
    • 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)
    • Severe: defined as all coronal pulp is infiltrated

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2020
Registry last updated
Feb 14, 2022

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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