Children's Comfort With Isolite and Rubber Dam During Dental Treatment (COMFORT)

Successful restorative treatment in pediatric dentistry depends not only on the technical quality of the procedure but also on the child's ability to tolerate treatment comfortably. Effective isolation plays a critical role by providing adequate moisture control, improving operative visibility, reducing contamination, and enhancing procedural safety. Rubber dam has long been regarded as the reference standard for dental isolation because of its effectiveness in maintaining a dry operating field. However, its application may be associated with discomfort related to clamp placement, limited oral movement, restricted communication, and patient intolerance, particularly in younger children.

Integrated isolation systems have been developed to simplify isolation procedures while improving both clinical efficiency and the patient experience. Isolite is a single-use isolation system that combines continuous high-volume evacuation, soft tissue retraction, tongue protection, bite support, and intraoral illumination within a single mouthpiece. These features may facilitate restorative procedures by reducing the need for multiple auxiliary devices while potentially improving children's comfort throughout treatment. Despite these theoretical advantages, clinical evidence regarding the influence of Isolite on children's treatment experiences remains limited.

This study is designed as a prospective, randomized, crossover clinical trial to compare Isolite and conventional rubber dam during restorative treatment of bilateral permanent mandibular first molars in children. A crossover design was selected because each participant receives both isolation techniques, allowing direct within-subject comparisons while minimizing interindividual variability and improving statistical efficiency. The order of the isolation methods will be randomly allocated, and both treatment sessions will be performed under standardized clinical conditions by the same operator using identical restorative protocols.

The study focuses on patient-centered outcomes that reflect children's experiences during restorative treatment. In addition to evaluating treatment comfort and satisfaction, the study will assess behavioral pain responses and treatment duration to provide a comprehensive comparison of the two isolation techniques. By simultaneously examining subjective and objective treatment outcomes, the study aims to determine whether the integrated design of Isolite offers measurable benefits over conventional rubber dam beyond effective clinical isolation.

The findings are expected to provide high-quality clinical evidence regarding the impact of isolation techniques on children's treatment experiences and procedural efficiency. The results may contribute to evidence-based, patient-centered decision-making in pediatric restorative dentistry and support clinicians in selecting isolation methods that optimize both clinical performance and the overall treatment experience for pediatric patients.