Dental Restoration Failure of Marginal Integrity Clinical Trial
Official title:
Comparative Study on the Outcomes of Restoring Untreated and SDF-treated Dentine Caries Lesions in Primary Teeth of Preschool Children
The primary objective of this proposed clinical study is to compare the success rates of ART
restorations placed in untreated and SDF-treated dentine caries lesions in primary teeth. The
secondary objective is to describe the change in parents' satisfaction with the aesthetics of
their child's teeth and the change in oral health-related quality of life of preschool
children before and after placement of ART restorations.
The study population is preschool children attending kindergartens in different districts in
Hong Kong. Children attending grades 1 or 2 in nine kindergartens were invited to receive a
free dental examination and had their decayed primary teeth restored, if possible, in the
kindergarten by dentists. Parental informed consent was obtained before the dental
examination and treatment. Half of the children with decayed primary teeth needing
restorations were assigned randomly to receive SDF treatment around 10 weeks before receiving
the restoration. The restored teeth were re-examined every 6 months for 24 months to assess
the treatment outcome. Parents of the study children were asked to complete a questionnaire
at baseline, 6 months and 24 months so as to obtain data on their satisfaction with the
aesthetics of their child's teeth and the oral health-related quality of life of the study
children.
The study population of this proposed study is Hong Kong preschool children. Children
attending grade 1 or 2 in nine selected kindergartens were invited to join this study. An
invitation letter with information on the purpose and procedures of the study was sent to the
parents of the children through the kindergarten. The parents were asked to give written
consent for allowing their child to receive a free oral examination and ART restorations, if
indicated for treating the decayed primary teeth in their child's mouth, provided by dentists
in the kindergarten. Parental consent were obtained before inclusion of a child in this
study.
Cavitated caries lesions in the primary teeth of the study children were restored following
the ART procedures (Holmgren et al., 2013). The instruments used were LED illuminated dental
mirror, sickle probe, tweezers, hatchet, excavators and flat plastic. The dental restorative
material used was a high-strength chemical-cured glass ionomer (Ketac-molar, 3M ESPE,
Germany).
At the baseline, all children with parental consent were clinically examined in the
kindergarten. Disposable dental mirror attached to a handle with an intra-oral LED light and
a ball-ended probe was used. The status of each tooth was recorded. Children who had at least
one decayed primary tooth with a cavity into dentine were included into the study. All
decayed teeth in the children were restored, except those with inadequate access and those
with signs of pulpal pathology. The decayed teeth in half of the children received topical
application of a SDF solution (Saforide, Toyo Chemical, Japan), through simple random
allocation on a child basis using random numbers, around 10 weeks before receiving the
restoration. The time used for placement of each restoration was recorded to the nearest
minute.
The children were examined at 6 and will be examined at 12, 18 and 24 months after placement
of ART restorations by calibrated examiners who were not involved in the placement of the
restorations. The same instruments used in the baseline examination were used in the
follow-up examinations. The status of the restorations and restored teeth were assessed and
recorded using codes and criteria commonly adopted in previous clinical studies of ART
restorations (Lo et al., 2007).
At baseline, information on the children's oral hygiene practice, snacking habit, oral health
related quality of life, and parental satisfaction with the appearance of their child's teeth
was collected by a self-completed questionnaire. A validated tool for measuring oral health
related quality of life of preschool children in Hong Kong, Chinese version of Early
Childhood Oral Health Impact Scale (ECOHIS), was used (Lee et al., 2009). The same
measurement tool was used at the 6-month and will be used at 24-month follow-up.
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