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Can a new dental device make Kids' cavity fillings less scary?

NCT ID NCT07718412

Symptom relief Sponsor: Cumhuriyet University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial tests whether an all-in-one dental isolation system called Isolite is more comfortable for children than the traditional rubber dam during cavity treatment. Sixty-six kids aged 8 to 12 will try both methods in random order, and researchers will measure pain, comfort, and satisfaction. The goal is to see if Isolite can improve the dental experience for young patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Isolite isolation system and rubber dam isolation
What this could lead to
If Isolite proves more comfortable, it could become a preferred isolation method for children's dental procedures, improving their treatment experience.
What could go wrong
This is a small crossover trial with 66 children, so results may not apply broadly. Isolite may not significantly improve comfort over rubber dam.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

66 people

The number who actually took part.

Started

Jul 2025

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

dental caries Patient Satisfaction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dental caries

Contacts and locations

Locations

  • Faculty of Dentistry, Sivas Cumhuriyet University

    Sivas, Merkez, 58050, Turkey (Türkiye)

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Other studies related to the condition(s) this trial covers.