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COMPLETED
NCT07493200
NA

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

Sponsor: Beyhan Başkan

View on ClinicalTrials.gov

Summary

This study evaluated whether wearing an earplug during root canal treatment reduces the gag reflex and the stress it causes. Forty adults who had a severe or very severe gag reflex were randomly divided into two groups. One group received an earplug in the ear opposite to the side being treated; the other group received standard treatment without an earplug. The severity of the gag reflex was scored by an observer, stress was measured using a saliva sample (salivary alpha-amylase), and treatment time and gag-related interruptions were recorded. The results showed that the earplug group had lower gag-reflex scores, lower stress levels, and shorter treatment times with fewer interruptions. No side effects were reported. These findings suggest that a simple, low-cost earplug may help patients who gag easily during dental treatment.

Official title: The Effect of Using Custom-Made Silicone Earplips on Gag Reflex Severity, Behavioral Responses, and Salivary Alpha-Amylase Levels as a Stress Biomarker in Patients Undergoing Root Canal Treatment: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-05-12

Completion Date

2026-02-05

Last Updated

2026-10-05

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Custom-Made Silicone Earplug

A personalized earplug fabricated from a soft, two-component addition-cure silicone (C-type silicone), commonly used for dental impressions. The two components are mixed according to the manufacturer's instructions and gently injected into the patient's external auditory canal on the side contralateral to the tooth receiving treatment. The silicone is allowed to polymerize for approximately 2-3 minutes, creating a custom-fit plug that conforms precisely to the individual contours of the ear canal. This ensures comfortable, continuous, and gentle tactile stimulation to the walls of the ear canal throughout the entire root canal procedure. The earplug is removed at the end of the treatment and is for single-patient use only. No other devices or pharmacological agents are used in conjunction with this intervention.

Locations (1)

Kahramanmaraş Sütçü İmam Universty

Kahramanmaraş, Turkey (Türkiye)