Pulp Necroses Clinical Trial
Official title:
Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry (A Randomized Controlled Clinical Trial)
Verified date | March 2022 |
Source | University of Alexandria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim of the study is to assess canal disinfection using matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) in single visit and multiple visit regeneration protocols, and to assess clinical and radiographic outcomes of single visit and multiple visit regeneration protocols.
Status | Terminated |
Enrollment | 16 |
Est. completion date | March 15, 2021 |
Est. primary completion date | March 10, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 18 Years |
Eligibility | Inclusion Criteria: - Immature permanent upper anterior teeth. - Necrotic teeth confirmed by sensibility test. - Teeth with periapical lesions confirmed by periapical radiograph using paralleling device. Exclusion Criteria: - Teeth with orthodontic wires or brackets. - Patient with history of allergy to any medication. - Patient with history of bleeding disorders. - Patient with medical illness or taking medications. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Nourhan M.Aly | Alexandria University |
Egypt,
Aggarwal V, Miglani S, Singla M. Conventional apexification and revascularization induced maturogenesis of two non-vital, immature teeth in same patient: 24 months follow up of a case. J Conserv Dent. 2012 Jan;15(1):68-72. doi: 10.4103/0972-0707.92610. — View Citation
Altaii M, Richards L, Rossi-Fedele G. Histological assessment of regenerative endodontic treatment in animal studies with different scaffolds: A systematic review. Dent Traumatol. 2017 Aug;33(4):235-244. doi: 10.1111/edt.12338. Epub 2017 Apr 20. Review. — View Citation
Chaniotis A. The use of a single-step regenerative approach for the treatment of a replanted mandibular central incisor with severe resorption. Int Endod J. 2016 Aug;49(8):802-12. doi: 10.1111/iej.12515. Epub 2015 Aug 21. — View Citation
Chueh LH, Ho YC, Kuo TC, Lai WH, Chen YH, Chiang CP. Regenerative endodontic treatment for necrotic immature permanent teeth. J Endod. 2009 Feb;35(2):160-4. doi: 10.1016/j.joen.2008.10.019. Epub 2008 Dec 12. — View Citation
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El Ashiry EA, Farsi NM, Abuzeid ST, El Ashiry MM, Bahammam HA. Dental Pulp Revascularization of Necrotic Permanent Teeth with Immature Apices. J Clin Pediatr Dent. 2016;40(5):361-6. doi: 10.17796/1053-4628-40.5.361. — View Citation
Estrela C, Bueno MR, Azevedo BC, Azevedo JR, Pécora JD. A new periapical index based on cone beam computed tomography. J Endod. 2008 Nov;34(11):1325-1331. doi: 10.1016/j.joen.2008.08.013. Epub 2008 Sep 17. — View Citation
Flanagan TA. What can cause the pulps of immature, permanent teeth with open apices to become necrotic and what treatment options are available for these teeth. Aust Endod J. 2014 Dec;40(3):95-100. doi: 10.1111/aej.12087. Review. — View Citation
Garcia-Godoy F, Murray PE. Recommendations for using regenerative endodontic procedures in permanent immature traumatized teeth. Dent Traumatol. 2012 Feb;28(1):33-41. doi: 10.1111/j.1600-9657.2011.01044.x. Epub 2011 Jul 27. Review. — View Citation
Jung IY, Lee SJ, Hargreaves KM. Biologically based treatment of immature permanent teeth with pulpal necrosis: a case series. J Endod. 2008 Jul;34(7):876-87. doi: 10.1016/j.joen.2008.03.023. Epub 2008 May 16. — View Citation
Khoshkhounejad M, Shokouhinejad N, Pirmoazen S. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes. J Dent (Tehran). 2015 Jun;12(6):460-8. — View Citation
McCabe P. Revascularization of an immature tooth with apical periodontitis using a single visit protocol: a case report. Int Endod J. 2015 May;48(5):484-97. doi: 10.1111/iej.12344. Epub 2014 Aug 27. — View Citation
McTigue DJ, Subramanian K, Kumar A. Case series: management of immature permanent teeth with pulpal necrosis: a case series. Pediatr Dent. 2013 Jan-Feb;35(1):55-60. — View Citation
Nagata JY, Rocha-Lima TF, Gomes BP, Ferraz CC, Zaia AA, Souza-Filho FJ, De Jesus-Soares A. Pulp revascularization for immature replanted teeth: a case report. Aust Dent J. 2015 Sep;60(3):416-20. doi: 10.1111/adj.12342. Epub 2015 Jul 29. — View Citation
Saoud TM, Huang GT, Gibbs JL, Sigurdsson A, Lin LM. Management of Teeth with Persistent Apical Periodontitis after Root Canal Treatment Using Regenerative Endodontic Therapy. J Endod. 2015 Oct;41(10):1743-8. doi: 10.1016/j.joen.2015.07.004. Epub 2015 Aug 14. — View Citation
Saoud TMA, Ricucci D, Lin LM, Gaengler P. Regeneration and Repair in Endodontics-A Special Issue of the Regenerative Endodontics-A New Era in Clinical Endodontics. Dent J (Basel). 2016 Feb 27;4(1). pii: E3. doi: 10.3390/dj4010003. Review. — View Citation
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Topçuoglu G, Topçuoglu HS. Regenerative Endodontic Therapy in a Single Visit Using Platelet-rich Plasma and Biodentine in Necrotic and Asymptomatic Immature Molar Teeth: A Report of 3 Cases. J Endod. 2016 Sep;42(9):1344-6. doi: 10.1016/j.joen.2016.06.005. Epub 2016 Jul 15. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microbiological assessment | The presence or absence of reduction in types of micro-organisms in root canals | 24 hours | |
Primary | Tooth vitality | Tooth vitality will be assessed by sensibility testing using thermal stimulation, binary (yes or no). | up to 12 months | |
Primary | Tooth mobility | 4. Mobility will be recorded according to Grace & Smales Mobility Index
Grade 0: No apparent mobility Grade 1: Perceptible mobility <1mm in buccolingual direction Grade 2: 1mm< but <2mm Grade 3: 2mm< or depressibility in the socket |
up to 12 months | |
Primary | Healing of periapical lesions | Periapical index score (PAI) will be used for identification of apical periodontitis on both periapical radiography and Cone-beam computed tomographic (CBCT).
It is a 6-point (0 -5) scoring system with 2 additional variables, expansion of cortical bone and destruction of cortical bone.The PAI will be determined by the largest extension of the lesion on periapical radiography and CBCT scans in 3 dimensions: axial, sagittal, and coronal. Score 0 Intact periapical bone structures. Score 1 Diameter of periapical radiolucency "0.5-1 mm. Score 2 Diameter of periapical radiolucency "1-2 mm. Score 3 Diameter of periapical radiolucency "2-4 mm. Score 4 Diameter of periapical radiolucency "4-8 mm. Score 5 Diameter of periapical radiolucency "8 mm. Score (n)# E: Expansion of periapical cortical bone. Score (n)# D: Destruction of periapical cortical bone. |
up to 12 months | |
Primary | Root lengthening | The root length will be measured as a straight line from the CEJ to the radiographic apex of the tooth. This will be measured on both periapical radiography and Cone-beam computed tomographic (CBCT) in millimeters. | up to 12 months | |
Primary | Root thickening | The dentinal wall thickness for both the preoperative and recall images will be measured at the level of the apical one third of the preoperative root canal length measured from the CEJ. The root canal width and the pulp space will be measured at this level, and the remaining dentin thickness will be calculated by subtracting the pulp space from the root canal width. | up to 12 months |
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