The Use of Platelet-Rich Fibrin in Partial Pulpotomy Procedure

NCT04331964 | Completed DMC

• 1 other identifier: UDDS-OperDent-01-2020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpitis

Keywords

Partial pulpotomy, platelet rich fibrin

Outcome Measures

Primary Outcomes (4)

• Thickness of dentin bridge

  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

  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

  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

  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 Outcomes (2)

• Postoperative pain: VAS

  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

  this outcome will be examined every week until the eighth week after intervention

Study Arms (2)

Mineral Trioxide Aggregate (MTA)

ACTIVE COMPARATOR

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

MTA with platelet rich fibrin (PRF).

EXPERIMENTAL

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

Interventions

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.

MTA with platelet rich fibrin (PRF).; Mineral Trioxide Aggregate (MTA)

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

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

Damascus, DM20AM18, Syria

Location

Related Publications (7)

• Azimi S, Fazlyab M, Sadri D, Saghiri MA, Khosravanifard B, Asgary S. Comparison of pulp response to mineral trioxide aggregate and a bioceramic paste in partial pulpotomy of sound human premolars: a randomized controlled trial. Int Endod J. 2014 Sep;47(9):873-81. doi: 10.1111/iej.12231. Epub 2014 Jan 13.

  PMID: 24330490 BACKGROUND

• Bakhtiar H, Nekoofar MH, Aminishakib P, Abedi F, Naghi Moosavi F, Esnaashari E, Azizi A, Esmailian S, Ellini MR, Mesgarzadeh V, Sezavar M, About I. Human Pulp Responses to Partial Pulpotomy Treatment with TheraCal as Compared with Biodentine and ProRoot MTA: A Clinical Trial. J Endod. 2017 Nov;43(11):1786-1791. doi: 10.1016/j.joen.2017.06.025. Epub 2017 Aug 16.

  PMID: 28822566 BACKGROUND

• Chailertvanitkul P, Paphangkorakit J, Sooksantisakoonchai N, Pumas N, Pairojamornyoot W, Leela-Apiradee N, Abbott PV. Randomized control trial comparing calcium hydroxide and mineral trioxide aggregate for partial pulpotomies in cariously exposed pulps of permanent molars. Int Endod J. 2014 Sep;47(9):835-42. doi: 10.1111/iej.12225. Epub 2014 Jan 28.

  PMID: 24299006 BACKGROUND

• Hiremath H, Saikalyan S, Kulkarni SS, Hiremath V. Second-generation platelet concentrate (PRF) as a pulpotomy medicament in a permanent molar with pulpitis: a case report. Int Endod J. 2012 Jan;45(1):105-12. doi: 10.1111/j.1365-2591.2011.01973.x. Epub 2011 Nov 14.

  PMID: 22077790 BACKGROUND

• Mehrvarzfar P, Abbott PV, Mashhadiabbas F, Vatanpour M, Tour Savadkouhi S. Clinical and histological responses of human dental pulp to MTA and combined MTA/treated dentin matrix in partial pulpotomy. Aust Endod J. 2018 Apr;44(1):46-53. doi: 10.1111/aej.12217. Epub 2017 Aug 18.

  PMID: 28833942 BACKGROUND

• Solomon RV, Faizuddin U, Karunakar P, Deepthi Sarvani G, Sree Soumya S. Coronal Pulpotomy Technique Analysis as an Alternative to Pulpectomy for Preserving the Tooth Vitality, in the Context of Tissue Regeneration: A Correlated Clinical Study across 4 Adult Permanent Molars. Case Rep Dent. 2015;2015:916060. doi: 10.1155/2015/916060. Epub 2015 May 17.

  PMID: 26097752 BACKGROUND

• Woo SM, Kim WJ, Lim HS, Choi NK, Kim SH, Kim SM, Jung JY. Combination of Mineral Trioxide Aggregate and Platelet-rich Fibrin Promotes the Odontoblastic Differentiation and Mineralization of Human Dental Pulp Cells via BMP/Smad Signaling Pathway. J Endod. 2016 Jan;42(1):82-8. doi: 10.1016/j.joen.2015.06.019. Epub 2015 Sep 9.

  PMID: 26364004 BACKGROUND

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rami Zenaldeen, DDS MSc

  PhD student at the Endodontic and Operative Dentistry Department, University of Damascus Dental School, Damascus, Syrian Arab Republic

  STUDY DIRECTOR

• Ossama Aljabban, DDS MSc PhD

  Professor at Endodontic and Operative Dentistry Department, University of Damascus Dental School, Damascus, Syrian Arab Republic

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor at Department of Orthodontics, University of Damascus Dental School, Damascus, Syrian Arab Republic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 2, 2020
• Study Start: May 1, 2020
• Primary Completion: October 15, 2021
• Study Completion: December 23, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

SY (1)