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

Treatment Comfort and Satisfaction With Isolite Versus Rubber Dam During Restorative Dental Treatment in Children: A Randomized Crossover Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: Isolite; Procedure: Rubber Dam Isolation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Merkez
    • Sivas, Merkez, Turkey (Türkiye), 58050
      • Faculty of Dentistry, Sivas Cumhuriyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isolite First; Participants receive restorative dental treatment using the Isolite isolation system during the first treatment visit, followed by rubber dam isolation during the second treatment visit.	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.
Active Comparator: Rubber Dam First; Participants receive restorative dental treatment using rubber dam isolation during the first treatment visit, followed by the Isolite isolation system during the second treatment visit.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Comfort	Patient comfort will be assessed using the Treatment Comfort and Satisfaction Scale, a multidimensional 100-mm Visual Analogue Scale (VAS) developed to evaluate children's treatment experiences during restorative dental treatment. The scale assesses physiological comfort (breathing, mouth opening, swallowing, movement, saliva control, gingival pressure, and pain), psychological comfort (fear/anxiety and feeling of safety), and interaction-related comfort (ability to communicate with the dentist and willingness to receive future treatment with the same isolation method). Each item is scored on a 100-mm scale ranging from 0 to 100, with higher scores indicating greater comfort.	Immediately after completion of each restorative treatment procedure at Visit 1 (Day 1) and Visit 2 (Day 15).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Pain	Behavioral pain will be assessed during restorative dental treatment using the Face, Legs, Activity, Cry, and Consolability (FLACC) Behavioral Pain Scale. Total scores range from 0 to 10, with higher scores indicating greater behavioral pain	Periprocedural during each restorative treatment procedure at Visit 1 (Day 1) and Visit 2 (Day 15).

Collaborators and Investigators

• Sponsor: Cumhuriyet University

Publications and helpful links

General Publications

• Bagher SM, Sabbagh HJ. A literature review of clinical efficiency, patient satisfaction, and future preference of Isolite and DryShield dental isolation systems among pediatric patients. J Clin Pediatr Dent. 2023 Jul;47(4):1-8. doi: 10.22514/jocpd.2023.029. Epub 2023 Jul 3.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): October 10, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Patient Satisfaction; Patient Comfort; dental dam; isolite
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Behavior; Treatment Adherence and Compliance; Health Behavior; Dental Caries; Patient Satisfaction
• Other Study ID Numbers: DIS-2024-329 (Other Grant/Funding Number: Scientific Research Project Fund of SCU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available because the informed consent obtained from participants and their legal guardians did not include permission for public sharing of de-identified individual-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No