Clinical trial NCT04331964: The Use of Platelet-Rich Fibrin in Partial Pulpotomy Procedure
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpitis
Keywords: Partial pulpotomy, platelet rich fibrin
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Thickness of dentin bridge
timeFrame: eight weeks after intervention
measure: Appearance of dentin bridge
timeFrame: eight weeks after intervention
measure: Intensity of Pulp Inflammation
timeFrame: eight weeks after intervention
measure: Extension of Pulp Inflammation
timeFrame: eight weeks after intervention
Secondary outcomes:
measure: Postoperative pain: VAS
timeFrame: using a 0 to 10-cm visual analog scale (VAS) scale, pain will be record every 24 hours until the seventh day after intervention
measure: Sensitivity to thermal stimuli
timeFrame: this outcome will be examined every week until the eighth week after intervention
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Endodontics and Operative Dentistry, University of Damascus Dental School, Damascus, Syria
Study officials:
affiliation: PhD student at the Endodontic and Operative Dentistry Department, University of Damascus Dental School, Damascus, Syrian Arab Republic
name: Rami Zenaldeen, DDS MSc
role: STUDY_DIRECTOR
affiliation: Professor at Endodontic and Operative Dentistry Department, University of Damascus Dental School, Damascus, Syrian Arab Republic
name: Ossama Aljabban, DDS MSc PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor at Department of Orthodontics, University of Damascus Dental School, Damascus, Syrian Arab Republic
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.