Dental CariesCOMFORTNCT07718412
Children's Comfort With Isolite and Rubber Dam During Dental Treatment
A study testing Isolite and Rubber Dam Isolation in people with Dental Caries, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Isolite and Rubber Dam Isolation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry, Sivas Cumhuriyet University
Sivas, Merkez, 58050
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Isolite, Rubber Dam Isolation
- Keywords
- dental dam, isolite, Patient Comfort, Patient Satisfaction
- Medical subject headings
- Dental Caries, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoliteDevice
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.
Rubber Dam IsolationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Isolite; Procedure: Rubber Dam Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after completion of each restorative treatment procedure at Visit 1 (Day 1) and Visit 2 (Day 15).
Secondary outcomes (1)
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
Measured: Periprocedural during each restorative treatment procedure at Visit 1 (Day 1) and Visit 2 (Day 15).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Jul 2025
- Primary completion10 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BURAK BULDUR, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718412
- Sponsor's protocol ID
- DIS-2024-329
- Other IDs
- DIS-2024-329
- Acronym
- COMFORT
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 37408340
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Comfort and Satisfaction With Isolite Versus Rubber Dam During Restorative Dental Treatment in Children: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07718412
- Acronym / sponsor ID
- COMFORT / DIS-2024-329
- Conditions
- Dental Caries
- Keywords
- dental dam, isolite, Patient Comfort, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Isolite First | Experimental | Device: Isolite, Procedure: Rubber Dam IsolationParticipants receive restorative dental treatment using the Isolite isolation system during the first treatment visit, followed by rubber dam isolation during the second treatment visit. |
| Rubber Dam First | Active comparator | Device: Isolite, Procedure: Rubber Dam IsolationParticipants receive restorative dental treatment using rubber dam isolation during the first treatment visit, followed by the Isolite isolation system during the second treatment visit. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsoliteAn 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. | Device | Isolite First, Rubber Dam First |
| Rubber Dam IsolationConventional 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. | Procedure or surgery | Isolite First, Rubber Dam First |
Primary outcome
Patient Comfort
Time frame: 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.
1 secondary outcome
Behavioral Pain
Time frame: Periprocedural during each restorative treatment procedure at Visit 1 (Day 1) and Visit 2 (Day 15).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Results publication: PubMed 37408340Bagher 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolite and Rubber Dam Isolation in people with Dental Caries, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Comfort (time frame: Immediately after completion of each restorative treatment procedure at Visit 1 (Day 1) and Visit 2 (Day 15).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07718412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.