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

NCT07493200 | Active Not Recruiting

• 1 other identifier: HRÜ/24.09.54
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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:
• Gag Reflex Severity: The intensity of the gag reflex will be recorded using the Dickinson and Fiske index.
• Behavioral Responses: Patient discomfort will be assessed by observing specific behaviors like eye squeezing, hand clenching, or groaning, using a simple scoring system.
• Treatment Duration: The total treatment time and any pauses caused by the gag reflex will be timed and recorded.
• 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.

Conditions

Gag Reflex

Keywords

Salivary Alpha-Amylase; Root Canal Treatment; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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).

  At the time of the root canal procedure (single time point during the most challenging part of treatment)

Secondary Outcomes (1)

• Behavioral Response Score

  Throughout the root canal procedure (continuous observation)

Other Outcomes (2)

• Gag-Related Pause Ratio

  Throughout the root canal procedure (continuous timing)

• Salivary Alpha-Amylase Level Change

  Immediately before and immediately after the root canal procedure (two time points)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Device: Custom-Made Silicone Earplug

Control Group

NO INTERVENTION

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.

Interventions

Custom-Made Silicone Earplug DEVICE

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beyhan Başkan: lead

Study Sites (1)

Kahramanmaraş Sütçü İmam Universty

Kahramanmaraş, 46140, Turkey (Türkiye)

Location

Related Publications (4)

• Rosted P, Bundgaard M, Fiske J, Pedersen AM. The use of acupuncture in controlling the gag reflex in patients requiring an upper alginate impression: an audit. Br Dent J. 2006 Dec 9;201(11):721-5; discussion 715. doi: 10.1038/sj.bdj.4814305.

  PMID: 17159959 BACKGROUND

• Yoshida H, Ayuse T, Ishizaka S, Ishitobi S, Nogami T, Oi K. Management of exaggerated gag reflex using intravenous sedation in prosthodontic treatment. Tohoku J Exp Med. 2007 Aug;212(4):373-8. doi: 10.1620/tjem.212.373.

  PMID: 17660702 BACKGROUND

• Eitner S, Wichmann M, Holst S. "Hypnopuncture"--a dental-emergency treatment concept for patients with a distinctive gag reflex. Int J Clin Exp Hypn. 2005 Jan;53(1):60-73. doi: 10.1080/00207140490914243.

  PMID: 15788244 BACKGROUND

• Garg R, Singhal A, Agrawal K, Agrawal N. Managing endodontic patients with severe gag reflex by glossopharyngeal nerve block technique. J Endod. 2014 Sep;40(9):1498-500. doi: 10.1016/j.joen.2014.01.028. Epub 2014 Mar 6.

  PMID: 25146042 BACKGROUND

MeSH Terms

Conditions

Gagging

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor responsible for recording behavioral responses and the laboratory analyst performing the salivary alpha-amylase measurements are blinded to the group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are randomly assigned to one of two parallel groups: an experimental group receiving the earplug intervention and a control group receiving no intervention.

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: May 12, 2025
• Primary Completion: February 5, 2026
• Study Completion: April 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)