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

Beyhan Başkan

Status: Active, not recruiting

Conditions: Gag Reflex

Treatments: Device: Custom-Made Silicone Earplug

Study type: Interventional

Funder types: Other

Identifiers

NCT07493200

HRÜ/24.09.54

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Patients in this group (n=20) will have a custom-made silicone earplug placed in the ear opposite the side where the dentist is working during their root canal treatment. The earplug is fabricated immediately before the procedure using soft silicone material to ensure a comfortable, personalized fit. No other pharmacological or behavioral interventions for gag reflex control will be used.

Treatment:

Device: Custom-Made Silicone Earplug

Control Group

No Intervention group

Description:

Patients in this group (n=20) will receive standard root canal treatment without any earplug placement. No interventions for gag reflex control will be used. All outcome measures (gag reflex severity, behavioral responses, treatment pause ratio, salivary alpha-amylase) will be collected in the same manner as for the experimental group.