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Children's Comfort With Isolite and Rubber Dam During Dental Treatment
Sponsor: Cumhuriyet University
Summary
Effective isolation is essential for successful restorative dental treatment in children because it improves moisture control, treatment quality, and patient safety. Rubber dam has long been considered the standard isolation technique; however, some children may experience discomfort during its use. Isolite is an integrated isolation system that combines suction, soft tissue retraction, bite support, and illumination in a single device and may improve the child's treatment experience. The purpose of this randomized crossover clinical trial is to compare Isolite and rubber dam with respect to behavioral pain, patient comfort, patient satisfaction, and treatment duration during restorative dental treatment in children. Sixty-six children requiring bilateral restorative treatment of permanent mandibular first molars will receive treatment with both isolation techniques in a randomized order during two separate appointments, allowing each participant to serve as his or her own control. Behavioral pain will be assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) Behavioral Pain Scale. Patient comfort and patient satisfaction will be evaluated immediately after each treatment session using a visual analogue scale, and treatment duration will also be recorded. The findings are expected to provide evidence regarding the influence of different isolation techniques on children's treatment experiences and may support patient-centered decision-making in pediatric restorative dentistry.
Official title: Treatment Comfort and Satisfaction With Isolite Versus Rubber Dam During Restorative Dental Treatment in Children: A Randomized Crossover Clinical Trial
Key Details
Gender
All
Age Range
8 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2025-07-01
Completion Date
2025-10-30
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
Isolite
An integrated dental isolation system used during restorative dental treatment. The device combines continuous high-volume suction, soft tissue retraction, tongue protection, bite support, and intraoral illumination to provide moisture control and improve access to the operative field throughout the procedure.
Rubber Dam Isolation
Conventional rubber dam isolation used during restorative dental treatment to provide moisture control and isolation of the operative field. A rubber dam sheet, clamp, frame, and punch are used to isolate the treated tooth according to standard clinical procedures.
Locations (1)
Faculty of Dentistry, Sivas Cumhuriyet University
Sivas, Merkez, Turkey (Türkiye)