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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
Plastic earplugs on both ears
Sea Bands put on the wrists of the participant to apply pressure on P6 points
Non pressure bands put on the wrists of the participant
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, Saudi Arabia
RECRUITINGChange from baseline Gagging severity index score
Gagging severity index (GSI) is a scale of gagging severity which ranges from 1 to 5 (very mild to very severe)
Time frame: At the time of first impression which is made before applying the intervention method (baseline score) and again at the time of the second impression which is made after application of the intervention method by 10 minutes
Change from baseline Visual Analogue Scale scoring of patient's satisfaction during impression making
The participant will be asked to score their judgment of the impression experience on a 0-10 scale where 0 refers to extremely pleasant and 10 refers to extremely unpleasant
Time frame: Directly after first impression which is made before applying the intervention (baseline score) and directly after the second impression which is made after application of the intervention method by 10 minutes
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