Simple earplug may stop gagging during root canals
NCT ID NCT07493200
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a custom-made silicone earplug placed in the ear can reduce the gag reflex and stress in 40 adults undergoing root canal treatment. Participants with severe gagging are randomly assigned to receive either the earplug or standard care. Researchers will measure gag severity, discomfort, and stress levels using saliva samples.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Custom-made silicone earplug
- What this could lead to
- If it works, this simple earplug could offer a safe, drug-free way to ease gagging and stress during dental procedures.
- What could go wrong
- This is a small, early-stage trial with only 40 participants, so results may not apply to everyone. The earplug may not work for all patients.
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
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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
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40 people
The number who actually took part.
- Started
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May 2025
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Adult patients aged 18 years and older. * Patients requiring non-surgical root canal treatment on a permanent tooth. * Patients classified with a severe (score 4) or very severe (score 5) gag reflex according to the Dickinson and Fiske Gagging Severity Index. * Patients who provide written informed consent to participate in the study. Exclusion Criteria: * Patients with a mild or moderate gag reflex (Dickinson and Fiske scores 1, 2, or 3). * Patients with any known ear pathology, anatomical anomaly of the ear canal, or active ear infection that would preclude the use of an earplug. * Patients with a history of vertigo or balance disorders. * Patients with medical conditions that could affect salivary flow or composition (e.g., Sjögren's syndrome, uncontrolled diabetes). * Patients taking medications that could influence salivary alpha-amylase levels (e.g., systemic corticosteroids, psychotropic drugs). * Pregnant or breastfeeding women. * Patients unable to provide informed consent or comply with the study protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kahramanmaraş Sütçü İmam Universty
Kahramanmaraş, 46140, Turkey (Türkiye)
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