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PulpitisNCT04331964

The Use of Platelet-Rich Fibrin in Partial Pulpotomy Procedure

A study testing partial pulpotomy in people with Pulpitis, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Pulpitis
What is being tested?
partial pulpotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSyria
Study dates
1 May 2020to 23 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Syria1 site

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

    Damascus, DM20AM18

Other trials in Syria

About this study

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

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.

Read the 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.

Conditions
Pulpitis
Being tested
partial pulpotomy
Keywords
Partial pulpotomy, platelet rich fibrin
Medical subject headings
Pulpitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • partial pulpotomyProcedure or surgery

    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.

Study groups in NCT04331964
Study groupRoleWhat they receive
Mineral Trioxide Aggregate (MTA)Active comparatorA 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.
Receives: Procedure: partial pulpotomy
MTA with platelet rich fibrin (PRF).ExperimentalA 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.
Receives: Procedure: partial pulpotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: eight weeks after intervention

  2. 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

    Measured: eight weeks after intervention

  3. 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.

    Measured: eight weeks after intervention

  4. 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

    Measured: eight weeks after intervention

Secondary outcomes (2)

  1. Postoperative pain: VAS

    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.

    Measured: using a 0 to 10-cm visual analog scale (VAS) scale, pain will be record every 24 hours until the seventh day after intervention

  2. Sensitivity to thermal stimuli

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2020
  2. Study start1 May 2020
  3. Primary completion15 Oct 2021
  4. Study completion23 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04331964
Sponsor's protocol ID
UDDS-OperDent-01-2020
Status last verified
Feb 2022
First submitted
29 Mar 2020
Last updated
14 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24330490

  • 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.

    PubMed 28822566

  • 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.

    PubMed 24299006

  • 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.

    PubMed 22077790

  • 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.

    PubMed 28833942

  • 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.

    PubMed 26097752

  • 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.

    PubMed 26364004

Questions about this trial

What is this clinical trial studying?

A study testing partial pulpotomy in people with Pulpitis, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thickness of dentin bridge (time frame: eight weeks after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04331964, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.

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