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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
40
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.
Kahramanmaraş Sütçü İmam Universty
Kahramanmaraş, Turkey (Türkiye)
Gag Reflex Severity
The severity of the gag reflex will be assessed using the Dickinson and Fiske Gagging Severity Index, a 5-point ordinal scale: 1=Normal (very mild, occasional, controllable by patient), 2=Mild (control achieved with support from dental team), 3=Moderate (consistent, limits treatment options), 4=Severe (occurs with any type of treatment, including simple visual examination), 5=Very Severe (affects patient behavior and dental visits, makes treatment impossible). The score will be recorded by the operator at the most challenging point of the root canal procedure (e.g., during rubber dam placement or access cavity preparation).
Time frame: At the time of the root canal procedure (single time point during the most challenging part of treatment)
Behavioral Response Score
Patient discomfort will be assessed by a trained observer (blinded to group allocation) who will record the presence or absence of 8 specific behavioral signs of distress during the procedure: (1) eye squeezing, (2) sweating (forehead or upper lip), (3) muscle tension (hand clenching, leg movements), (4) withdrawal/attempts to avoid treatment, (5) groaning, (6) crying, (7) breath-holding, (8) increased saliva production. The total score (0-8) is calculated by summing the number of observed signs. This total score is further categorized as mild (0-2), moderate (3-4), severe (5-6), or very severe (7-8) for analysis.
Time frame: Throughout the root canal procedure (continuous observation)
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