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Clinical management of immature non-vital (necrotic) permanent teeth is challenging, due to inherent structural weakness. Earlier management of such teeth relied on the traditional calcium hydroxide (Ca(OH)2) apexification procedure or the application of apical barriers However, neither procedure allows for promoting root dentin maturation. In 2004, a novel management technique for treating immature, non-vital teeth called regenerative endodontic procedures (REP; also known as revascularization) was introduced. This procedure allowed for continued root maturation presented in an increase in root length and dentin wall thickness. The key points of REP include minimal or no instrumentation of the dentinal walls, disinfection with irrigant solutions and intracanal medicaments, provocation of bleeding into the canal space for creation of a blood clot, capping with calcium silicate-based material, and an effective coronal seal to prevent reinfection of the root canal system. Several case reports and clinical studies reported promising results for REP treatment. However, studies widely varied in their treatment methods, hence the search for an optimal REP protocol is still ongoing. A recent review reported that the methodological quality of REP clinical trials available to date, was low with a moderate to high risk of bias. To date, only few studies evaluated the outcome of REPs based on different types of intracanal medicaments. These studies either presented a retrospective design, low sample size and/or short follow up period. Hence, the need for randomized, controlled clinical studies to provide persuasive evidence on the efficacy of different intracanal medicaments in REP is of utmost importance. The aim of this study is to prospectively assess and compare the clinical and radiographic outcomes of REP in non-vital immature permanent teeth using an intracanal medicament modified TAP or non-setting Ca(OH)2 paste. Forty-five patients yielding a total of 50 anterior and posterior non-vital immature teeth were randomly divided into 2 groups. REP utilizing either non-setting calcium hydroxide (Ca(OH)2) (n=25) or modified triple antibiotic paste (TAP) (n=25), as intracanal medicaments were performed. NeoMTA Plus was applied for coronal sealing. Cases were followed up clinically and radiographically for 24 months. Survival rate, success rate, and clinical outcome measures were analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-setting calcium hydroxide | Experimental | Regenerative Endodontic Procedure utilizing non-setting calcium hydroxide as intracanal medicament |
|
| modified triple antibiotic paste | Experimental | Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regenerative Endodontic Procedures | Procedure | Regenerative Endodontic procedures were performed by one operator following similar protocols according to the clinical considerations for a regenerative procedure advised by the American Association of Endodontists and European Society of Endodontology |
| Measure | Description | Time Frame |
|---|---|---|
| treatment success | disappearance of clinical signs and symptoms including tenderness to percussion or palpation, a swelling or sinus tract, or spontaneous pain, and absence or reduction in the size of periapiacl radiolucency | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| root elongation | increased root length | 36 months |
| root maturation | increased root dentin thickness | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aladdin A Al-Qudah, PhD | Jordan University of Science & Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of Science & Technology | Irbid | 22110 | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28508244 | Result | Duggal M, Tong HJ, Al-Ansary M, Twati W, Day PF, Nazzal H. Interventions for the endodontic management of non-vital traumatised immature permanent anterior teeth in children and adolescents: a systematic review of the evidence and guidelines of the European Academy of Paediatric Dentistry. Eur Arch Paediatr Dent. 2017 Jun;18(3):139-151. doi: 10.1007/s40368-017-0289-5. Epub 2017 May 15. | |
| 25443280 |
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all IPD that underlie results in a publication will be shared
starting 12 months after publication
will be sent by email, upon request
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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This randomized clinical trial aimed to assess and compare the clinical and radiographic outcomes of Regenerative Endodontic Procedures (REP) in treating non-vital immature permanent teeth using two intracanal medicaments.
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|
| non-setting calcium hydroxide | Other | non-setting calcium hydroxide |
|
| modified triple antibiotic paste | Other | modified triple antibiotic paste |
|
| root completion | apical closure | 36 months |
| Result |
| Saoud TM, Zaazou A, Nabil A, Moussa S, Lin LM, Gibbs JL. Clinical and radiographic outcomes of traumatized immature permanent necrotic teeth after revascularization/revitalization therapy. J Endod. 2014 Dec;40(12):1946-52. doi: 10.1016/j.joen.2014.08.023. Epub 2014 Oct 16. |
| 33934366 | Result | European Society of Endodontology (ESE) developed by:; Krastl G, Weiger R, Filippi A, Van Waes H, Ebeleseder K, Ree M, Connert T, Widbiller M, Tjaderhane L, Dummer PMH, Galler K. European Society of Endodontology position statement: endodontic management of traumatized permanent teeth. Int Endod J. 2021 Sep;54(9):1473-1481. doi: 10.1111/iej.13543. Epub 2021 Jun 20. |
| 34352304 | Result | Sponchiado-Junior EC, Vieira WA, Frozoni M, Herkrath FJ, de-Jesus-Soares A. CONSORT Compliance in Randomized Clinical Trials of Regenerative Endodontic Treatments of Necrotic Immature Teeth: A Scoping Review. J Endod. 2021 Nov;47(11):1751-1766. doi: 10.1016/j.joen.2021.07.017. Epub 2021 Aug 3. |
| 28110920 | Result | Chan EK, Desmeules M, Cielecki M, Dabbagh B, Ferraz Dos Santos B. Longitudinal Cohort Study of Regenerative Endodontic Treatment for Immature Necrotic Permanent Teeth. J Endod. 2017 Mar;43(3):395-400. doi: 10.1016/j.joen.2016.10.035. Epub 2017 Jan 19. |
| 32249441 | Result | ElSheshtawy AS, Nazzal H, El Shahawy OI, El Baz AA, Ismail SM, Kang J, Ezzat KM. The effect of platelet-rich plasma as a scaffold in regeneration/revitalization endodontics of immature permanent teeth assessed using 2-dimensional radiographs and cone beam computed tomography: a randomized controlled trial. Int Endod J. 2020 Jul;53(7):905-921. doi: 10.1111/iej.13303. Epub 2020 Apr 30. |