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Clinical Trial

The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment

NCT: NCT07493200 · ACTIVE_NOT_RECRUITING

NCT IDNCT07493200
StatusACTIVE_NOT_RECRUITING
Start Date2025-05-12
Completion2026-04-30

Brief Summary

Background: Root canal treatment is a common dental procedure used to save infected teeth. However, some patients experience a strong gag reflex during the treatment. This reflex can make it very difficult for the dentist to work, cause significant stress for the patient, and prolong the procedure. Current methods to control the gag reflex, such as anesthesia or sedation, can be complicated, require special equipment, or have side effects. Therefore, finding a simple, safe, and effective method to manage this reflex is important. Objective: This study aims to investigate whether using a simple, custom-made silicone earplug can help reduce the gag reflex, improve patient comfort, and lower stress levels during root canal treatment. The earplug is thought to work by creating a mild sensory distraction in the ear canal, which may interfere with the nerve signals responsible for triggering the gag reflex. Participants: The study will include 40 adult patients who have a severe or very severe gag reflex (scores 4 or 5 on the Dickinson and Fiske Gagging Severity Index) and require root canal treatment. Methods: Participants will be randomly divided into two equal groups: * Experimental Group (20 patients): These patients will have a custom-made silicone earplug placed in the ear opposite the side where the dentist is working during their root canal treatment. * Control Group (20 patients): These patients will receive the same root canal treatment but without an earplug. For all participants, the investigators will measure: 1. Gag Reflex Severity: The intensity of the gag reflex will be recorded using the Dickinson and Fiske index. 2. Behavioral Responses: Patient discomfort will be assessed by observing specific behaviors like eye squeezing, hand clenching, or groaning, using a simple scoring system. 3. Treatment Duration: The total treatment time and any pauses caused by the gag reflex will be timed and recorded. 4. Stress Levels: To objectively measure stress, saliva samples will be taken from each patient before and after the treatment. These samples will be analyzed in a laboratory to measure the level of alpha-amylase, an enzyme that increases with stress. Expected Outcomes: The investigators expect that patients in the earplug group will experience a less severe gag reflex, show fewer signs of discomfort, have fewer interruptions during their treatment, and have lower stress levels (indicated by lower alpha-amylase in their saliva) compared to the control group. If successful, this simple technique could offer a safe and easily applicable way to improve the dental experience for patients troubled by a gag reflex.

Frequently Asked Questions

What is The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment?

The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment is a clinical trial registered under NCT07493200. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT07493200?

The current status of NCT07493200 (The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment) is: ACTIVE_NOT_RECRUITING.

When did The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment start?

The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment started on 2025-05-12.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.