Gagging Clinical Trial
Official title:
Ear Plugs Versus Acupressure for Management of Severe Gag Reflex: A Randomized Clinical Trial
The aim of this study is to evaluate the efficacy of two proposed non-invasive techniques: the ear plug technique and acupressure on the P6 point in reducing gag reflex during impression making and to assess patient's experience in terms of comfort and satisfaction.
The study will take place at the clinics of Riyadh Colleges of Dentistry and Pharmacy (RCsDP)
in Riyadh, Saudi Arabia.
Patients, who on previous occasions have demonstrated difficulties in accepting the procedure
of making impressions of maxillary teeth due to a severe gag reflex (GR) will be invited to
participate in the study.
A Randomized single blinded clinical trial will be conducted on 30 participants who fulfill
the inclusion criteria. Participants will be assigned to three separate groups. For each
patient, two maxillary alginate impressions will be made; one before applying the proposed
management technique and one after. Participants of Group EP (n=10) will be managed using
earplugs while Group AC (n=10) will be managed using acupressure band and Group PL (n=10)
will receive placebo management in forms of regular bands.
Informed consent will be obtained from all participants. All impressions will be made by one
dentist that will be blinded to the gag reflex (GR) management techniques. The GR evaluation
for all the participants will be performed by another calibrated dentist who is also blinded
to the applied technique.
The severity of gag reflex will be assessed during making of the first impression using
Dickinson & Fiske (2005) gagging severity index (GSI).
After 20 minutes of making the first impression, participants of Group EP will be asked to
place the earplugs in and wait in the waiting room for 10 minutes. Then, the second
impression will be made while the participant still has the earplugs on. Group AC will have
acupressure technique via sea aid bands which will be placed on the P6 points of both hand
wrists. Participants will be asked to wait in the waiting room for 10 minutes then the second
impression will be made. PL Group will have the placebo management via placebo bands ( with
no pressure points ) which will be placed on both hand wrists. Participants will also be
asked to wait in the waiting room for 10 minutes then the second impression will be made. The
effectiveness of the treatment will be assessed using Dickinson & Fiske (2005) gagging
prevention index (GPI).
Participants will be asked to rate their discomfort during impression making using visual
analogue scale (VAS).
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