Dental Caries
Conditions
Keywords
dental dam, isolite, Patient Comfort, Patient Satisfaction
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.
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.
Interventions
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.
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
Study design
Masking description
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.
Intervention model description
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.
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort | Immediately after completion of each restorative treatment procedure at Visit 1 (Day 1) and Visit 2 (Day 15). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Pain | Periprocedural during each restorative treatment procedure at Visit 1 (Day 1) and Visit 2 (Day 15). | 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 |
Countries
Turkey (Türkiye)