Treatment time, pain experience and acceptability of the technique for caries removal in primary teeth using the ART approach with or without Brix3000™ papain gel: a preliminary randomised controlled clinical trial

T F de Souza, M L Martins, C M Tavares-Silva, A Fonseca-Gonçalves, L C Maia, T F de Souza, M L Martins, C M Tavares-Silva, A Fonseca-Gonçalves, L C Maia

Abstract

Purpose: To compare the Atraumatic Restorative Treatment (ART) associated with Brix3000™ to ART considering treatment time, pain experienced, and acceptability to children.

Methods: This study was accepted in Research Ethics Committee in July 2019 (number 3469402). Healthy patients (n = 20) aged 3-9 years, with at least one primary molar with occlusal dentine caries without cusp involvement were randomly allocated to either the ART + Brix3000™ group or the ART-only group. The sample was characterised by sex, age, tooth location and caries experience. Time spent and pain experience scores were recorded at prophylaxis, caries removal and restoration. The pain experience (intense, moderate, or mild) was evaluated by the Face, Legs, Activity, Cry, Consolability-revised scale (FLACC-r). Acceptability was assessed by a five-point hedonic facial scale (dichotomised into 'like' and 'indifferent/dislike' bins) and by an open-question interview. Mann-Whitney, Chi-square, and Fisher's exact tests were applied to discern differences in time, pain/sample characterisation and acceptability, respectively.

Results: The ART + Brix3000™ group required 8.6 ± 3.1 min to remove caries tissue, whereas the ART group required only 4.8 ± 2.0 min (p = 0.03). The total time spent with treatments was 13.1 ± 4.0 min for ART + Brix3000™, and 9.8 ± 2.7 min for ART (p = 0.03). There was no difference in pain experience and acceptability found among the groups (p > 0.05).

Conclusion: Although the ART + Brix3000™ technique demanded more treatment time than the ART alone, there were no differences in either pain experience or acceptability.

Keywords: Children; Dental caries; Pain; Papain.

Conflict of interest statement

The authors declare that Brix3000™ was donated for the study but any researcher have direct connection with the company involved in the donation. Besides, the company did not interfere in the analysis and results of this research.

© 2021. European Academy of Paediatric Dentistry.

Figures

Fig. 1
Fig. 1
Hedonic scale with five facial expressions that indicates: (1) disliked a lot, (2) disliked, (3) indifference, (4) liked, (5) loved
Fig. 2
Fig. 2
Consort flow diagram of the trial
Fig. 3
Fig. 3
Mean time of the prophylaxis, caries removal, restoration, and total of dental treatment. Statistical analyses were performed using Man-Whitney test and the significance level was considered as p < 0.05. Different lowercase letters show statistically significant differences between groups

References

    1. Abdul Khalek A, Elkateb MA, Abdel Aziz WE, El Tantawi M. Effect of papacarie and alternative restorative treatment on pain reaction during caries removal among children: a randomized controlled clinical trial. J Clin Pediatr Dent. 2017;41(3):219–224. doi: 10.17796/1053-4628-41.3.219.
    1. Alkhouli MM, Al Nesser SF, Bshara NG, AlMidani AN, Comisi JC. Comparing the efficacies of two chemo-mechanical caries removal agents (2.25% sodium hypochlorite gel and brix 3000), in caries removal and patient cooperation: A randomized controlled clinical trial. J Dent. 2020; 93:103280. 10.1016/j.jdent.2020.103280
    1. Ayres M, Ayres junior M, Ayres DL, Santos AAS. BioEstat 5.0: Aplicacoes Estatisticas Nas Areas Das Ciencias Biologicas E Médicas, Available at: MCT, IDSM, CNPq, Belem, 2007, p. 364 .
    1. Bussadori SK, Castro LC, Galvão AC. Papain gel: a new chemo-mechanical caries removal agent. J Clin Pediatr Dent. 2005;30(2):115–9. 10.17796/jcpd.30.2. xq641w720u101048
    1. Bussotti EA, Guinsburg R, Pedereira MLG. Adaptação cultural para o português do Brasil da escala de avaliação de dor Face, Legs, Activity, Cry, Consolability revised (FLACCr) Rev Latino-Am Enfermagem. 2015;23(4):651–659. doi: 10.1590/0104-1169.0001.2600.
    1. Carvalho TS, Ribeiro TR, Bönecker M, Pinheiro EC, Colares V. The atraumatic restorative treatment approach: an "atraumatic" alternative. Med Oral Patol Oral Cir Bucal. 2009;14(12):e668–e673. doi: 10.4317/medoral.14.e668.
    1. Deng Y, Feng G, Hu B, Kuang Y, Song J. Effects of Papacarie on children with dental caries in primary teeth: a systematic review and meta-analysis. Int J Paediatr Dent. 2018;28(4):361–372. doi: 10.1111/ipd.12364.
    1. Domene SMA, Veiga FM, Marino CRP, Assumpção ALM, Zabotto CB, Vítolo MR. Rev. Ciênc. Méd., Campinas, 2002;11(2): 129–136
    1. Frankl SN, Shire FR, Fogels HR. Should the parent remain with the child in the dental operatory? J Dent Child. 1962;29(2):150–162.
    1. Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135–40; discussion 161–3. 10.1111/j.1752-7325. 1996.tb02423. x.
    1. Kochhar GK, Srivastava N, Pandit IK, Gugnani N, Gupta M. An evaluation of different caries removal techniques in primary teeth: a comparitive clinical study. J Clin Pediatr Dent. 2011;36(1):5–9. 10.17796/jcpd.36.1.u2421l4j68847215.
    1. Kumar KVKS, Prasad MG, Sandeep RV, Reddy SP, Divya D, Pratyusha K. Chemomechanical caries removal method versus mechanical caries removal methods in clinical and community-based setting: A comparative in vivo study. Eur J Dent. 2016;10(3):386–391. doi: 10.4103/1305-7456.184151.
    1. Ladewig NM, Tedesco TK, Gimenez T, Braga MM, Raggio DP. Patient-reported outcomes associated with different restorative techniques in pediatric dentistry: A systematic review and MTC meta-analysis. PLoS One. 2018;13(12):e0208437. doi: 10.1371/journal.pone.0208437.
    1. Leal SC, Abreu DM, Frencken JE. Dental anxiety and pain related to ART. J Appl Oral Sci. 2009;17 Suppl(spe):84–8. 10.1590/s1678-77572009000700015
    1. Malviya S, Voepel-Lewis T, Burke C, Merkel S, Tait AR. The revised FLACC observational pain tool: improved reliability and validity for pain assessment in children with cognitive impairment. Paediatr Anaesth. 2006;16(3):258–265. doi: 10.1111/j.1460-9592.2005.01773.x.
    1. Mandari GJ, Truin GJ, van't Hof MA, Frencken JE. Effectiveness of three minimal intervention approaches for managing dental caries: survival of restorations after 2 years. Caries Res. 2001;35(2):90–4. 10.1159/000047438.
    1. Petersen, Poul Erik, Baez, Ramon J & World Health Organization (2013). Oral health surveys: basic methods, 5th ed. World Health Organization.
    1. Schulz KF, Altman DG, Moher D, for the CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. J Clin Epi. 2010;63(8):834–840. doi: 10.1016/j.jclinepi.2010.02.005.
    1. Schwendicke F. Chemomechanical excavation is more time-consuming than rotary, but not necessarily hand excavation. J Evid Based Dent Pract. 2015;15(4):190–192. doi: 10.1016/j.jebdp.2015.10.004.
    1. Schwendicke F. Caries removal in primary teeth using Papacarie. Evid Based Dent. 2018;19(3):74. doi: 10.1038/sj.ebd.6401321.
    1. Seligman LD, Hovey JD, Chacon K, Ollendick TH. Dental anxiety: An understudied problem in youth. Clin Psychol Rev. 2017;55:25–40. doi: 10.1016/j.cpr.2017.04.004.
    1. Silva FC, Thuller LCS. Tradução e adaptação transcultural de duas escalas para avaliação da dor em crianças e adolescente. J Pediatr (Rio J). 2008;84(4):344–349.
    1. Topaloglu-Ak A, Eden E, Frencken JE. Perceived dental anxiety among schoolchildren treated through three caries removal approaches. J Appl Oral Sci. 2007;15(3):235–240. doi: 10.1590/s1678-77572007000300015.
    1. Venkataraghavan K, Kush A, Lakshminarayana C, Diwakar L, Ravikumar P, Patil S, Karthik S. Chemomechanical caries removal: a review & study of an indigen-ously developed agent (Carie care (TM) gel) in children. J Int Oral Health. 2013;5(4):84–90.
    1. Vila-Sierra L, Candelario-Guette SS, Carrascal-Calderon CY, Miranda-Soraca X, Rodriguez-Oñate Y. Ansiedad, miedo y comportamentoen odontopediatria utilizando Brix 3000 y método rotatorio para remoción de caries. Duazary. 2019 mayo; 16(2número especial): 383–394. 10.21676/2389783X.3160.

Source: PubMed

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