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

NCT07718412 | Completed

• 1 other identifier: DIS-2024-329
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dental dam; isolite; Patient Comfort; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Behavioral Pain

  Periprocedural during each restorative treatment procedure at Visit 1 (Day 1) and Visit 2 (Day 15).

Study Arms (2)

Isolite First

EXPERIMENTAL

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; Procedure: Rubber Dam Isolation

Rubber Dam First

ACTIVE COMPARATOR

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; Procedure: Rubber Dam Isolation

Interventions

Isolite DEVICE

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.

Isolite First; Rubber Dam First

Rubber Dam Isolation PROCEDURE

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.

Isolite First; Rubber Dam First

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Faculty of Dentistry, Sivas Cumhuriyet University

Sivas, Merkez, 58050, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37408340 RESULT

MeSH Terms

Conditions

Dental Caries; Patient Satisfaction

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of participants and the operator was not feasible because of the nature of the interventions. However, behavioral pain assessments were performed by an independent examiner who was not involved in the clinical procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Dentistry, Faculty of Dentistry, Sivas Cumhuriyet University

Model Details: Each participant receives restorative dental treatment using both Isolite and rubber dam in a randomized sequence during two separate treatment sessions. The crossover design allows each participant to serve as his or her own control.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 30, 2025
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)