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Ear Plugs Versus Acupressure for Management of Severe Gag Reflex

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ClinicalTrials.gov Identifier: NCT02938364
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammad Ramadan Rayyan, Riyadh Colleges of Dentistry and Pharmacy

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gagging Other: Earplugs Other: Acupressure Other: Placebo Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ear Plugs Versus Acupressure for Management of Severe Gag Reflex: A Randomized Clinical Trial
Actual Study Start Date : October 25, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: Earplugs
The participant will be asked to put plastic earplugs in both ears for 10 minutes and then the impression will be made while they are still on.
Other: Earplugs
Plastic earplugs on both ears

Experimental: Acupressure
The participant will be asked to wear sea bands on P6 points of both hand wrists for 10 minutes and then the impression will be made while they are still on.
Other: Acupressure
Sea Bands put on the wrists of the participant to apply pressure on P6 points

Placebo Comparator: Placebo
The participant will be asked to wear non pressure bands on both hand wrists for 10 minutes and then the impression will be made while they are still on.
Other: Placebo
Non pressure bands put on the wrists of the participant




Primary Outcome Measures :
  1. Change from baseline Gagging severity index score [ 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 ]
    Gagging severity index (GSI) is a scale of gagging severity which ranges from 1 to 5 (very mild to very severe)


Secondary Outcome Measures :
  1. Change from baseline Visual Analogue Scale scoring of patient's satisfaction during impression making [ 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 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The individual is able to give informed consent.
  • Patients with GR severity that are assigned to a gagging severity index (GSI) III-IV (for standardization of the baseline severity in between Groups).

Exclusion Criteria:

  • Pregnant women
  • Patients with Chronic heart diseases or cardiac pacemakers
  • Patients with central or peripheral nervous system disorders
  • Patients with oral lesions
  • Patients with gastrointestinal disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938364


Contacts
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Contact: Mohammad R Rayyan, master +966508821318 dr_rayyan@riyadh.edu.sa

Locations
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Saudi Arabia
Riyadh Colleges of Dentistry and Pharmacy Recruiting
Riyadh, Saudi Arabia, 11681
Contact: Mohammad R Rayyan, master    00966508821318    dr_rayyan@riyadh.edu.sa   
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
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Principal Investigator: Mohammad R Rayyan, master Riyadh Colleges of Dentistry and Pharmacy

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Responsible Party: Mohammad Ramadan Rayyan, Assistant professor, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT02938364     History of Changes
Other Study ID Numbers: FUGRP/2016/115
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Gagging
Signs and Symptoms, Digestive
Signs and Symptoms