Influence of two caries detection strategies on the quality of life of preschool children: An analysis of secondary outcomes of a 2‐Year randomized clinical trial

Abstract

ObjectiveThis randomized clinical trial aimed to evaluate the influence of two caries diagnosis strategies, and subsequent management, on oral health‐related quality of life (OHRQoL) of preschoolers. Additionally, the association of the OHRQoL outcomes with the clinician‐centred primary outcome used in the main study was also explored.Materials and MethodsThis study refers to the OHRQoL secondary outcomes analyses of the so‐called RCT ‘CARDEC‐1’. Three‐ to 6‐year‐old children were randomly allocated in two caries detection strategies in primary molars: visual inspection (VIS) or visual + radiographic (RAD) assessment. Participants were diagnosed and treated according to the allocated group and followed up for 2 years. Caregivers answered the Early Childhood Oral Health Impact Scale (ECOHIS) at baseline and after 2 years. Intention‐to‐treat analysis was performed. ECOHIS scores at baseline and 2 years later were compared using the Mann–Whitney test. Effect sizes, change scores and the minimally important difference (MID) were also compared between groups. Additional analysis was performed to assess if OHRQoL variables could reflect the primary clinical outcome (number of new operative interventions during the follow‐up), observing if these met the Prentice criteria.ResultsTwo hundred and five children had the ECOHIS answered in both period times (18.7% attrition rate). There was a decrease in total ECOHIS scores, as well as for different domains for both trial groups, with effect sizes varying from 0.43 to 0.77. Comparisons between groups, however, did not show significant differences. In the additional analysis, the OHRQoL variables met the Prentice criteria and presented the same trends observed with the clinician‐centred primary endpoint.ConclusionCaries detection performed by visual inspection alone or associated with radiographic method does not influence the long‐term impact on OHRQoL. Furthermore, OHRQoL variables reflect clinical outcomes in this type of clinical trial. ClinicalTrials.gov NCT02078453.

Is there an acceptable surrogate for caries clinical trials? Evidence from a systematic review of primary studies

“…However, this type of outcome has rarely been used as primary outcome in dentistry 22 . It was recently found that changes in children's oral health‐related quality of life (by parental proxy) was related to the primary endpoint, a clinically centred measure (number of new operative interventions during the follow‐up) 23 . Findings such as this may indicate that PROMs in RCTs for dental caries should be considered as surrogates in future studies.…”

Desfechos centrados no paciente no tratamento endodôntico de molares decíduos sem instrumentação com pasta CTZ estudo clínico randomizado multicêntrico

“…Além disso o instrumento é composto por 13 questões, divididas em uma seção de impacto infantil (sintomas da criança, função, domínios psicológicos e de autoimagem/interação social) e uma seção de impacto familiar (domínios de sofrimento parental e função familiar). ECOHIS também demonstrou ser responsivo ao tratamento odontológico e refletir o comprometimento da saúde bucal, onde escores mais altos indicam um maior impacto negativo dos problemas de saúde bucal na QVRSB das crianças e suas famílias (3,31).…”