Crossover studies of pediatric dental sedation are inappropriate

Abstract Crossover studies continue to be published in spite of warnings about their inherent risks in relation to behavioral outcomes. This study took the opportunity of access to secondary data analysis in order to demonstrate the impact of a crossover design on the outcomes of randomized clinical trials aimed at the behavior of children during dental treatment. We evaluated the effect of the sequence of sedative administration, the sedative and the participant's age on the behavior of children undergoing two sequential dental visits. Eighteen uncooperative healthy young children were equally randomly assigned to: (G1) 1.0 mg/kg oral midazolam (first session) and oral placebo (second session); (G2) oral placebo (first) and 1.0 mg/kg oral midazolam (second). One trained observer assessed children's behavior. Data were analyzed by three-way mixed ANOVA. Both midazolam [mean(SD); 71.7%(16.5)] and placebo [48.6%(33.1)] produced more struggling behavior when they were administered in the first session compared to the second one (p=0.001). For the placebo, children aged 2-3 years exhibited more struggling behavior [G1 54.9%(36.2); G2 80.5%(8.3)] than those aged 4-5 years (p=0.04). Also, the reduction of percentage of struggling behavior was higher in G1 for older children (76.2%) and in G2 for younger children (32.9%). There were significant interactions between drug and sequence of administration, and between drug and age. The results of our study confirm the conventional wisdom that crossover study design is inappropriate to evaluate children's behavior/anxiety related-dental treatment under sedation and the results of crossover studies of dental sedation should be treated with extreme caution.

Resumo Pouco se sabe sobre o impacto de um delineamento cruzado nos desfechos de ensaios clínicos randomizados voltados ao comportamento de crianças durante tratamento odontológico. Este estudo objetivou avaliar o efeito da sequência de administração do sedativo, da droga em si e da idade dos participantes no comportamento de crianças que receberam duas consultas odontológicas consecutivas. Dezoito crianças saudáveis não colaboradoras, 2-5 anos de idade, foram randomizadas em dois grupos: G1 - 1,0 mg/kg midazolam oral (primeira sessão) e placebo oral (segunda sessão); G2 - placebo (primeira) e 1,0 mg/kg midazolam oral (segunda). Um observador treinado avaliou o comportamento infantil. Os dados foram analisados por ANOVA de três fatores (alfa=0,05). Midazolam [média(DP); 71,7%(16,5)] e placebo [48,6%(33,1)] resultaram em mais comportamento não cooperativo quando administrados na primeira sessão comparado com a segunda (p=0,001). Com o uso do placebo, crianças de 2-3 anos de idade exibiram mais comportamento não cooperativo [G1 54,9%(36,2); G2 80,5%(8,3)] que as de 4-5 anos de idade (p=0,04). Além disso, a porcentagem de redução do comportamento não cooperativo foi maior em crianças mais velhas em G1 (76,2%) e em crianças mais novas em G2 (32,9%). Considerando a avaliação do comportamento infantil sob sedação, a primeira sessão odontológica influenciou a segunda visita. Os resultados deste estudo confirmam a especulação de que o delineamento cruzado é inadequado para avaliar o comportamento odontológico relacionado à ansiedade/comportamento infantil; os resultados dos ensaios cruzados de sedação odontológica devem ser tratados com extrema cautela.

Is pain during pediatric dental sedation associated with children's pre-operative characteristics? An exploratory study / Dor durante sedação em odontopediatria associa-se a características pré-operatórias da criança? Estudo exploratório

Introduction: Little is known about the factors associated with the pain of children in dental treatment under conscious sedation. Objective: To investigate the association between preoperative characteristics and pain during pediatric dental treatment under sedation. Material and method: This exploratory study was conducted with 27 children in restorative treatment under sedation. Information on age, sex and experience of the children with previous dental treatment was obtained through interviews with parents. Oral health status, determined from the presence of dental caries, was verified using the dmf-t index. Pain was assessed by analyzing videos of the dental treatments by two previously calibrated examiners, using the items legs, activity and crying of the observational scale “face, legs, activity, consolability and crying (FLACC). Data were analyzed using bivariate tests. Result Most of the children (n=14, 51.8%) had no pain during dental treatment under sedation. Among the other children, lower or moderate pain scores (median 1.1; minimum 0 to 3.8) were observed. The FLACC scores did not vary according to sex (P=0.38), previous experience with dental treatment (P=0.32) and history with local anesthesia (P=0.96). The FLACC scores did not correlate significantly with age (Spearman rho= -0.08, P=0.67) and dmf-t (Spearman rho= -0.04, P=0.84). Conclusion In this group of children, pain during dental treatment under sedation was of low frequency and intensity and did not associate with age, sex, oral condition and previous dental experience.

Introdução: Pouco se sabe sobre os fatores associados à dor das crianças no tratamento odontológico sob sedação consciente. Objetivo: Verificar a associação entre as características pré-operatórias e a dor durante o tratamento odontopediátrico sob sedação. Material e método: Este estudo exploratório foi realizado com 27 crianças submetidas a tratamento restaurador sob sedação. As informações sobre idade, sexo e experiência de tratamento odontológico prévio da criança foram obtidas por meio de entrevista aos pais. A condição bucal, determinada a partir da presença de cárie dentária, foi verificada por meio do índice ceo-d. A dor foi avaliada por análise dos vídeos dos tratamentos, por dois examinadores previamente calibrados, utilizando-se os itens: pernas, atividade e choro da escala observacional . Face, pernas, atividade, consolabilidade e choro (FLACC). Os dados foram analisados por meio de testes bivariados. Resultado A maioria das crianças (n=14; 51,8%) não teve dor durante o tratamento odontológico sob sedação. Entre as demais crianças, observaram-se escores de dor baixos ou moderados (mediana 1,1; mínimo 0-3,8). Os escores FLACC não diferiram conforme sexo (P=0,38), experiência prévia de tratamento odontológico (P=0,32) e história de anestesia local (P=0,96). Os escores FLACC não se correlacionaram significativamente com idade (Spearman rho= -0,08; P=0,67) e ceo-d (Spearman rho= -0,04, P=0,84). Conclusão: Neste grupo de crianças, a dor durante tratamento odontológico sob sedação foi pouco observada, de baixa intensidade e não se associou a idade, sexo, condição bucal e experiência odontológica anterior.

Ineffectiveness of Antibiotic-Based Pulpotomy for Primary Molars: a Survival Analysis

To investigate the two-year survival rate of primary molars treated with non-instrumentation endodontic treatment with mixed antibiotic paste containing chloramphenicol, tetracycline, zinc oxide and eugenol (CTZ pulpotomy), and compare it to the conventional root canal treatment with calcium hydroxide paste. Material and Methods:Thirty-six children, mean age 6.2 years old (standard deviation, SD=1.5), presenting at least one primary molar with irreversible pulpitis or necrotic pulp, were included in this prospective clinical study. Teeth were assigned to CTZ pulpotomy (Group I) or calcium hydroxide pulpectomy (Group II) and assessed clinically and radiographically for up to 26 months. Data were analyzed using descriptive statistics, Chi-square test, Kaplan-Meier survival analysis and Log-rank test. Results:Fifty-three primary molars were treated in Group I (n=37) or Group II (n=16). Children were followed up for 1 to 26 months (mean=12.0; SD=7.1). Treatment failure rates were 73.0% in Group I and 31.3% in Group II. Overall, mean survival time was 15.2 months (95% confidence interval, CI 12.6û17.9); Group I (mean 13.2; 95% CI 10.2-16.3) had a lower survival rate than Group II (mean 18.9; 95% CI 14.5-23.2) (p=0.02). Necrotic pulp treatments had significantly lower survival rates (p=0.01) than pulpitis treatments. Conclusion:Non-instrumentation endodontic treatment of primary molars with CTZ paste resulted in a low survival rate in a two-year follow-up; its radiographic ineffectiveness discourages its use instead of conventional root canal endodontic treatment...