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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| 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:
| eight weeks after intervention |
| Extension of Pulp Inflammation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | using a 0 to 10-cm visual analog scale (VAS) scale, pain will be record every 24 hours until the seventh day after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endodontics and Operative Dentistry, University of Damascus Dental School, Damascus, Syria | Damascus | DM20AM18 | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24330490 | Background | 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. | |
| 28822566 | Background |
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| ID | Term |
|---|---|
| D011671 | Pulpitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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:
|
| eight weeks after intervention |
| 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:
| this outcome will be examined every week until the eighth week after intervention |
| 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. |
| 24299006 | 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. |
| 22077790 | 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. |
| 28833942 | 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. |
| 26097752 | 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. |
| 26364004 | 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. |