Effective Interventions to Overcome Severe Gag Reflex

NCT ID: NCT07099131

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-07

Study Completion Date

2028-12-07

Brief Summary

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The purpose of this study is to evaluate the use of various techniques in alleviating gag reflex following gag reflex stimulation.

Primary aim: To compare if there is any reduction in gag reflex from each of the following interventions

* Acupuncture (CV-24)
* Tape
* Anesthetic spray Secondary aim: to compare the degree of gag reduction

Detailed Description

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The purpose of this study is to evaluate the use of various techniques in alleviating gag reflex following gag reflex stimulation.

Primary aim: To compare if there is any reduction in gag reflex from each of the following interventions

* Acupuncture (CV-24)
* Tape
* Anesthetic spray Secondary aim: to compare the degree of gag reduction

Conditions

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Gagging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Unblinded. Subjects will be randomized. The three intervention groups are : Acupuncture (CV-24), Tape and Anesthetic Spray.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture (CV-24)

A 6C file (endodontic instrumentation file) will be placed on the patient's mentolabial fold (CV24). This file will be concealed by a small paper cup; A clean alcohol wipe will be used to clean the mentolabial area prior to placing the "acupuncture needle" (6 C-File).

Group Type EXPERIMENTAL

Acupuncture

Intervention Type DEVICE

A 6C file (endodontic instrumentation file) will be placed on the patient's mentolabial fold (CV24). This file will be concealed by a small paper cup; A clean alcohol wipe will be used to clean the mentolabial area prior to placing the "acupuncture needle" (6 C-File).

Tape

A piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup

Group Type EXPERIMENTAL

Masking Tape

Intervention Type GENETIC

A piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup

Anesthetic spray

Will be applied to back of the throat for 10 seconds; their chin will also be concealed from the GSI examiner using a small cup and masking tape.

Group Type EXPERIMENTAL

Anesthetic spray

Intervention Type DRUG

will be applied to back of the throat for 10 seconds; their chin will also be concealed from the GSI examiner using a small cup and masking tape.

Interventions

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Anesthetic spray

will be applied to back of the throat for 10 seconds; their chin will also be concealed from the GSI examiner using a small cup and masking tape.

Intervention Type DRUG

Acupuncture

A 6C file (endodontic instrumentation file) will be placed on the patient's mentolabial fold (CV24). This file will be concealed by a small paper cup; A clean alcohol wipe will be used to clean the mentolabial area prior to placing the "acupuncture needle" (6 C-File).

Intervention Type DEVICE

Masking Tape

A piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* 18 years or older (individuals below 18 years will be excluded from the study as the study procedures might not be well tolerated by them, and they are not the primary population on which these procedures are used).
* Students, faculty, or staff of Tufts SDM
* Subjects who score a 2 or higher on the Gagging Severity Index (GSI)7 and have a positive gag reflex response when stimulated with a cotton swab at the base of the tongue/uvula/tonsil region.

Exclusion Criteria

* Adults unable to consent (cognitively impaired adults)
* Wards of the state
* Pregnant women (those that are self-reported)
* Current use of anticoagulants
* Allergy to xylocaine
* Those with bleeding disorders
* Those who participated in the Calibration phase of this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Devon Ptak

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Dental Medicine

Locations

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Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Devon Ptak

Role: CONTACT

6176366889

Facility Contacts

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Devon Ptak

Role: primary

6176366889

Other Identifiers

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6213

Identifier Type: -

Identifier Source: org_study_id

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