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Clinical Trial NCT07493200 for Gag Reflex is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment 40

Active, not recruiting
Clinical Trial NCT07493200 is an interventional study for Gag Reflex that is active, not recruiting. It started on 12 May 2025 with plans to enroll 40 participants. Led by Beyhan Başkan, it is expected to complete by 30 April 2026. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 equipmen...

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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

Conditions
Gag Reflex
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • HRÜ724.09.54
NCT ID Number
NCT07493200
Start Date (Actual)
2025-05-12
Last Update Posted
2026-03-25
Completion Date (Estimated)
2026-04-30
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
Salivary Alpha-Amylase
Root Canal Treatment
Randomized Controlled Trial
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExperimental Group
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.
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 cu...Show More
No InterventionControl Group
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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Throughout the root canal procedure (continuous observation)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Beyhan Başkan logoBeyhan Başkan
Study Responsible Party
Beyhan Başkan, Sponsor-Investigator, Assistant Professor, Kahramanmaras Sutcu Imam University
No contact data.
1 Study Locations in 1 Countries
Kahramanmaraş Sütçü İmam Universty, Kahramanmaraş, 46140, Turkey (Türkiye)