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

NCT07718412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-07-22

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Cumhuriyet University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-10-10
Completion
2025-10-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07718412 on ClinicalTrials.gov