Study Results
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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NOT_YET_RECRUITING
EARLY_PHASE1
45 participants
INTERVENTIONAL
2025-12-07
2028-12-07
Brief Summary
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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
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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).
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).
Tape
A piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup
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
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.
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.
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.
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).
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Tufts University
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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6213
Identifier Type: -
Identifier Source: org_study_id
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