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Non-Restorative Versus Conventional Caries Treatment in Primary Teeth: A Randomized Controlled Trial
Sponsor: Lenka Likar Ostrc, DMD
Summary
Dental caries is common in young children, and treatment of cavities in primary teeth can be challenging. Conventional treatment usually involves removal of carious tooth tissue and placement of a restoration. In young children, however, this approach may be associated with discomfort, the need for local anaesthesia, and difficulties with cooperation. Minimally invasive approaches have therefore been developed to control caries while reducing the burden of treatment. The main goal of this study is to evaluate whether minimally invasive approaches for treating cavitated carious lesions in primary molars are clinically effective and acceptable to young children. The study also examines whether the type of treatment influences children's cooperation and discomfort during dental care, oral health-related quality of life, and treatment costs. The main research questions are whether minimally invasive treatments can provide clinical outcomes comparable with conventional restorative treatment, whether children cooperate better or experience less discomfort during minimally invasive treatment, and whether the different treatment approaches have different effects on oral health-related quality of life and treatment costs. Children aged 3 to 6 years attending selected public kindergartens are invited to participate. Children who meet the study criteria undergo a dental examination and, when indicated, radiographic assessment of the carious lesion. Eligible children are then randomly assigned to one of three treatment groups. In the conventional treatment group, carious tooth tissue is removed and the tooth is restored with a filling. In the selective caries removal group, only part of the carious dentine is removed before the cavity is restored. In the non-restorative caries treatment group, or NRCT, no conventional restoration is placed; instead, the cavity is made accessible for cleaning when necessary, fluoride varnish is applied, and children and parents receive instructions on oral hygiene and diet. After treatment, children's cooperation and perceived discomfort are assessed. During follow-up visits, the researchers evaluate oral hygiene, the condition of the treated teeth, progression of caries, and possible treatment-related complications. Parents also complete questionnaires assessing the child's oral health-related quality of life. The study is designed to determine whether less invasive treatment approaches can offer a safe, effective, and child-friendly alternative to conventional restorative treatment of caries in primary teeth. The findings may contribute to future recommendations and clinical guidelines for the management of cavitated carious lesions in children.
Official title: Clinical and Patient-Reported Outcomes of Non-Restorative Versus Conventional Caries Treatment in Primary Teeth: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
4 Years - 5 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2023-01-21
Completion Date
2028-10
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Non-restorative caries treatment (NRCT)
NRCT group - Non-restorative caries treatment (NRCT): Overhanging enamel, when present, was removed to improve access for cleaning. Fluoride varnish was applied to the cavitated lesion and the remaining dentition. Children and parents received dietary and oral hygiene instructions, with particular emphasis on effective cleaning of the cavitated lesion. CT group - Conventional restorative treatment (CT): Carious tissue was removed and the tooth was restored with a compomer restoration. Local anaesthesia was used when required. Fluoride varnish was applied to the dentition, and children and parents received dietary and oral hygiene instructions.
CT
CT group - Conventional restorative treatment (CT): Carious tissue was removed and the tooth was restored with a compomer restoration. Local anaesthesia was used when required. Fluoride varnish was applied to the dentition, and children and parents received dietary and oral hygiene instructions.
Locations (1)
University of Ljubljana
Ljubljana, Slovenia