Efficacy of the non-instrumentation endodontic treatment with CTZ paste in primary molars: Protocol of a multicenter randomized clinical trial with two years of follow-up
DOI:
https://doi.org/10.33448/rsd-v11i16.37140Keywords:
Endodontic Treatment; Primary Teeth; Non-instrumentation technique; CTZ paste; Pulpectomy.Abstract
Objective: There is a lack of high-quality evidence on the efficacy of the non-instrumentation endodontic treatment (NIET) in primary molars, compared to the conventional endodontic treatment technique. This protocol describes a multicenter randomized clinical trial that aims to evaluate the efficacy of a NIET technique for primary molars using a paste containing antibiotics (chloramphenicol and tetracycline – CTZ group) compared to a control group of conventional technique and root filling with zinc oxide eugenol (ZOE). Methodology: Children aged 3 to 9 years (N=218) will be randomly allocated to one of the groups: CTZ or ZOE. In CTZ, after the location of root canals entrance, irrigation will be performed using 1% sodium hypochlorite and CTZ paste will be placed over the root canal entrances, with no instrumentation of the root canals. In ZOE group, manual instrumentation of root canals with endodontic K-files will be performed, and then, the root canals will be filled with ZOE paste. At the same appointment, teeth will be restored with a double-seal of glass ionomer and a bulk fill resin composite. Children will be followed-up for 6, 12, 18 and 24 months. The primary endpoint will be the success of endodontic treatments evaluated by clinical and radiographic criteria after 24 months. Conclusions: NIET with CTZ paste could be an option to manage primary teeth, once the technique could have non-inferior efficacy to the conventional technique that involves root canal instrumentation. The approach could have good acceptance from children and parents considering the reduced clinical time.
References
Agarwal, S. R., Bendgude, V. D., & Kakodkar, P. (2019). Evaluation of Success Rate of Lesion Sterilization and Tissue Repair Compared to Vitapex in Pulpally Involved Primary Teeth: A Systematic Review. Journal of Conservative Dentistry, 22(6), 510–515. https://doi.org/10.4103/JCD.JCD_76_20
Barbosa, T. de S., Vicentin, M. D. S., & Gavião, M. B. D. (2011). Qualidade de vida e saúde bucal em crianças - Parte I: versão brasileira do Child Perceptions Questionnaire 8-10. Ciência & Saúde Coletiva, 16(10), 4077–4085. https://doi.org/10.1590/S1413-81232011001100013
Buchanan, H., & Niven, N. (2002). Validation of a Facial Image Scale to assess child dental anxiety. International Journal of Paediatric Dentistry, 12(1), 47–52. https://doi.org/10.1046/j.0960-7439.2001.00322.x
Cappiello, J. (1964). Tratamientos pulpares en incisivos primarios. Revista de La Asociación Odontológica Argentina, 52(4), 139–145.
Chan, A. W., Tetzlaff, J. M., Gøtzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., & Moher, D. (2013). SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 346, e7586. https://doi.org/10.1136/BMJ.E7586
Chouchene, F., Masmoudi, F., Baaziz, A., Maatouk, F., & Ghedira, H. (2021). Antibiotic Mixtures in Noninstrumental Endodontic Treatment of Primary Teeth with Necrotic Pulps: A Systematic Review. International Journal of Dentistry. https://doi.org/10.1155/2021/5518599
Coll, J. A., Dhar, V., Vargas, K., Chen, C. Y., Crystal, Y. O., AlShamali, S., & Marghalani, A. A. (2020). Use of Non-Vital Pulp Therapies in Primary Teeth. Pediatric Dentistry, 42(5), 337–349.
Coll, J. A., Vargas, K., Marghalani, A. A., Chen, C. Y., AlShamali, S., Dhar, V., & Crystal, Y. O. (2020). A Systematic Review and Meta-Analysis of Nonvital Pulp Therapy for Primary Teeth. Pediatric Dentistry, 42(4), 256–461.
De Deus Moura, L. de F. A., De Lima, M. de D. M., Lima, C. C. B., Machado, J. I. A. G., De Moura, M. S., & De Carvalho, P. V. (2016). Endodontic Treatment of Primary Molars with Antibiotic Paste: A Report of 38 Cases. The Journal of Clinical Pediatric Dentistry, 40(3), 175–177. https://doi.org/10.17796/1053-4628-40.3.175
de Oliveira, S. C. M., Floriano, I., Tedesco, T. K., Gimenez, T., Imparato, J. C. P., & Calvo, A. F. B. (2021). Cost analysis of endodontic treatment in primary teeth: results from a randomized clinical trial. Brazilian Oral Research, 35. https://doi.org/10.1590/1807-3107BOR-2021.VOL35.0126
Duarte, M. L., Pires, P. M., Ferreira, D. M., Pintor, A. V. B., Neves, A. de A., Maia, L. C., & Primo, L. G. (2020). Is there evidence for the use of lesion sterilization and tissue repair therapy in the endodontic treatment of primary teeth? A systematic review and meta-analyses. Clinical Oral Investigations, 24(9), 2959–2972. https://doi.org/10.1007/S00784-020-03415-0
Frankl, S. N. (1962). Should the parent remain with the child in the dental operatory? Journal of Dentistry for Children, 29(2), 150–162.
Garrocho-Rangel, A., Jalomo-Ávila, C., Rosales-Berber, M. Á., & Pozos-Guillén, A. (2021). Lesion Sterilization Tissue Repair (LSTR) Approach Of Non-Vital Primary Molars With A Chloramphenicol-Tetracycline-ZOE Antibiotic Paste: A Scoping Review. The Journal of Clinical Pediatric Dentistry, 45(6), 369–375. https://doi.org/10.17796/1053-4625-45.6.1
Hoshino, E., Kurihara-Ando, N., Sato, I., Uematsu, H., Sato, M., Kota, K., & Iwaku, M. (1996). In-vitro antibacterial susceptibility of bacteria taken from infected root dentine to a mixture of ciprofloxacin, metronidazole and minocycline. International Endodontic Journal, 29(2), 125–130. https://doi.org/10.1111/J.1365-2591.1996.TB01173.X
Lima, C. C. B., Conde Júnior, A. M., Rizzo, M. S., Moura, R. D., Moura, M. S., Lima, M. D. M., & Moura, L. F. A. D. (2015). Biocompatibility of root filling pastes used in primary teeth. International Endodontic Journal, 48(5), 405–416. https://doi.org/10.1111/IEJ.12328
Lokade, A., Thakur, S., Singhal, P., Chauhan, D., & Jayam, C. (2019). Comparative evaluation of clinical and radiographic success of three different lesion sterilization and tissue repair techniques as treatment options in primary molars requiring pulpectomy: An in vivo study. Journal of the Indian Society of Pedodontics and Preventive Dentistry, 37(2), 185. https://doi.org/10.4103/JISPPD.JISPPD_6_19
Luengo-Fereira, J., Ayala-Jiménez, S., Carlos-Medrano, L. E., Toscano-Garciá, I., & Anaya-Álvarez, M. (2019). Clinical and Radiographic Evaluation of Formocresol and Chloramphenicol, Tetracycline and Zinc Oxide-Eugenol Antibiotic Paste in Primary Teeth Pulpotomies: 24 month follow up. The Journal of Clinical Pediatric Dentistry, 43(1), 16–21. https://doi.org/10.17796/1053-4625-43.1.4
Martins-Júnior, P. A., Ramos-Jorge, J., Paiva, S. M., Marques, L. S., & Ramos-Jorge, M. L. (2012). Validations of the Brazilian version of the Early Childhood Oral Health Impact Scale (ECOHIS). Cadernos de Saúde Pública, 28(2), 367–374. https://doi.org/10.1590/S0102-311X2012000200015
Moura, J., Lima, M., Nogueira, N., Castro, M., Lima, C., Moura, M., & Moura, L. (2021). LSTR Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for the Treatment of Primary Molars with Pulp Necrosis: A Randomized Controlled Trial. Pediatric Dentistry, 43(6), 435–442.
Piaggio, G., Elbourne, D. R., Pocock, S. J., Evans, S. J. W., & Altman, D. G. (2012). Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA, 308(24), 2594–2604. https://doi.org/10.1001/JAMA.2012.87802
Sato, I., Ando-Kurihara, N., Kota, K., Iwaku, M., & Hoshino, E. (1996). Sterilization of infected root-canal dentine by topical application of a mixture of ciprofloxacin, metronidazole and minocycline in situ. International Endodontic Journal, 29(2), 118–124. https://doi.org/10.1111/J.1365-2591.1996.TB01172.X
Sato, T., Hoshino, E., Uematsu, H., & Noda, T. (1993). In vitro antimicrobial susceptibility to combinations of drugs on bacteria from carious and endodontic lesions of human deciduous teeth. Oral Microbiology and Immunology, 8(3), 172–176. https://doi.org/10.1111/J.1399-302X.1993.TB00661.X
Smaïl-Faugeron, V., Glenny, A. M., Courson, F., Durieux, P., Muller-Bolla, M., & Fron Chabouis, H. (2018). Pulp treatment for extensive decay in primary teeth. The Cochrane Database of Systematic Reviews, 5(5). https://doi.org/10.1002/14651858.CD003220.PUB3
Sousa, H. C. S., de Lima, M. de D. M., Lima, C. C. B., de Moura, M. S., Bandeira, A. V. L., & de Deus Moura, L. de F. A. (2020). Prevalence of Enamel Defects in Premolars Whose Predecessors Were Treated with Extractions or Antibiotic Paste. Oral Health & Preventive Dentistry, 18(1), 793–798. https://doi.org/10.3290/J.OHPD.A45083
Takushige, T., Cruz, E. V., Asgor Moral, A., & Hoshino, E. (2004). Endodontic treatment of primary teeth using a combination of antibacterial drugs. International Endodontic Journal, 37(2), 132–138. https://doi.org/10.1111/J.0143-2885.2004.00771.X
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2022 Pablo Silveira Santos; Natália Matsuda de Oliveira; Tatiane Ramos; Ana Paula Dornellas; Aurélio de Oliveira Rocha; Filipe Colombo Vitali; Bárbara Suelen Moccelini; Danielle Cristina Alves Rigo; Renata Pereira de Samuel Marques; Laura Regina Antunes Pontes; Juliana de Medeiros Matos; Márcia Costa Louvain; Vera Ligia Vieira Mendes Soviero; Tatiana Kelly da Silva Fidalgo; Michele Bolan; Carla Miranda Santana; Mariane Cardoso; Fausto Medeiros Mendes
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:
1) Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
2) Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
3) Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.