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Completed NCT07718412

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

Conditions: Dental Caries

Sex: All
Ages: 8 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 66
Sponsor: Cumhuriyet University

Location: Faculty of Dentistry, Sivas Cumhuriyet University Sivas Merkez

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.

Eligibility Criteria

Inclusion Criteria: * Children aged 8 to 12 years. * Systemically healthy children. * Presence of dentinal caries (ICDAS scores 4-6) requiring restorative treatment in bilateral permanent mandibular first molars. * Cooperative behavior, defined as a Frankl Behavior Rating Scale score of 3 or 4. * Ability of the child and parent/legal guardian to understand the study procedures and provide assent/consent. * Written informed consent provided by the parent or legal guardian. Exclusion Criteria: * Presence of systemic disease or special health care needs. * Acute dental pain, dental abscess, or dental trauma requiring emergency treatment. * Previous painful or negative dental experiences that could influence behavioral responses. * Known allergy or contraindication to any material used during treatment. * Inability to complete both treatment visits. * Refusal of the child or parent/legal guardian to participate.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07718412). StuddyBuddy aggregates publicly available trial information.