Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial

Abstract

BackgroundIn many parts of the world, school-age children have high dental treatment needs; however, there is often low, or no, dental care provision. Although Atraumatic Restorative Treatment (ART) was developed to address this, its survival rate in occluso-proximal lesions is low. An alternative, the Hall Technique (HT) has shown better relative outcomes for occluso-proximal lesions, but has not been directly compared to ART or tested in field settings. This trial will compare ART and the HT for the most clinically- and cost-effective strategy for managing occluso-proximal lesions in primary molars, in a school setting, using low-technology and child-friendly dental techniques.Methods/DesignThis two-arm, parallel group, patient-randomized controlled, superiority trial will have treatment provided in schools. Schoolchildren (n = 124, age 6–8) with at least one occluso-proximal carious primary molar lesion will have random allocation to treatment with ART or HT. Baseline measures and outcome data will be assessed through participant report, clinical examination and parent report/questionnaires. The primary outcome is survival rate, a composite measure of absence of Minor Failures (a defect in the restoration/crown, but not interfering with tooth health) and Major Failures (signs or symptoms of irreversible pulp damage, such as dental fistula/abscess, tooth fracture or failures that cannot be repaired). Secondary outcomes are: (1) child-reported discomfort, (2) childrens’ and (3) parents’ concerns around dental appearance and (4) acceptability of treatments, (5) occlusal-vertical dimensions (OVD) changes, (6) plaque index, (7) gingival health, (8) decayed, missing, filled teeth in permanent teeth (DMFT)/decayed, missing, filled teeth in primary teeth (dmft), (9) oral health-related-quality of life, reported by children and parents/caregivers, (10) the incremental cost-effectiveness, and (11) operator effect. A trained and calibrated examiner will evaluate the treated teeth after 1 week, then 1, 6, 12, 24 and 36 months post treatment. Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome. The Mann-Whitney or t test, Friedman test, paired t test or Wilcoxon test and Ordinal Logistic Regression Analysis will be used to analyze the secondary outcomes.DiscussionThe results of this trial will support decision-making by clinicians and policy-makers for managing occluso-proximal lesions in settings with constrained resources and limited dental access.Trial registrationwww.clinicaltrials.gov, NCT02569047, registered 5 October 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1270-z) contains supplementary material, which is available to authorized users.

Maternal perception of the impact of anterior caries and its treatment on children: A qualitative study

“…This reinforces previous qualitative study which showed that child oral health can impact their family's quality of life, contributing to stress, financial challenges, and at times affecting their physical health . It has been shown that cavitated lesions can make parents upset and feeling guilty about the condition of their children . Studies have showed that poor parental perception on OHRQoL and toothache in children was associated with parental guilt .…”

“…14 It has been shown that cavitated lesions can make parents upset and feeling guilty about the condition of their children. 18 Studies have showed that poor parental perception on OHRQoL and toothache in children was associated with parental guilt. 2,19,20 According to Guedes et al, 21 parents usually feel responsible for the well-being of their children.…”

Hall Technique in Pediatric Dentistry: Review

“…22 İnvaziv olmayan dizaynı, hasta tarafından kabul edilebilmekte ve uzun ömürlü bir restorasyon oluşundan dolayı tedavi edilmemiş süt dişi oranlarında düşüş sağlayabileceği düşünülmektedir. 23,24 Yapılan bir çalışmada, hem ailelerin hem de çocukların büyük çoğunluğunun PÇK'nin Hall tekniği ile uygulanmasından memnun olduğu; görüntü, ağrı ve prosedürün kabul edilebilir bulunduğu bildirilmiştir. 25 …”

“…Aile ve çocuk, Hall kronların estetik sonuç-larından memnuniyet duymayacak ise, Bu konuyla alakalı yapılan bir çalışmada, ailelerin PÇK'lerin estetiğinden memnun olmadığı ve bunun Hall tekniği açısından bir limitasyona neden olabileceği belirtilmiştir. 23 Otistik çocuklarda Hall tekniği kullanımının uygun olmayabileceği belirtilmiştir. 33 Eğer hasta bakteriyel endokardit açısından risk altında ise bütün çürük dokusunun uzaklaştırıl-dığı konvansiyonel yöntemler tercih edilmelidir (Evans D, Innes N. The Hall Technique.…”

“…23,32,36 2014 yılında yayımlanan retrospektif bir çalışmada, hem konvansiyonel yöntem hem de Hall tekniği kullanılarak PÇK ile restore edilen dişlerde yüksek oranda klinik başarı sağlandığı belirtilmiştir. 37 2014 yılında yayımlanan bir çalışmada da Hall tekniği, konvansiyonel teknik ve NRCT (restore edilmeyen çürük tedavisi), çocukların tedavi sırasındaki davranışları ve ağrı algıları açısından karşılaştırmalı olarak değerlendirilmiştir.…”