Ear Plugs Versus Acupressure for Management of Severe Gag Reflex

NCT ID: NCT02938364

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-25
• Study Completion Date: 2019-01-31

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.

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).

Conditions

Gagging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Earplugs

Intervention Type: OTHER

Plastic earplugs on both ears

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.

Group Type: EXPERIMENTAL

Acupressure

Intervention Type: OTHER

Sea Bands put on the wrists of the participant to apply pressure on P6 points

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Non pressure bands put on the wrists of the participant

Interventions

Earplugs

Plastic earplugs on both ears

Intervention Type: OTHER

Acupressure

Sea Bands put on the wrists of the participant to apply pressure on P6 points

Intervention Type: OTHER

Placebo

Non pressure bands put on the wrists of the participant

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Ramadan Rayyan

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad R Rayyan, master

Role: PRINCIPAL_INVESTIGATOR

Riyadh Colleges of Dentistry and Pharmacy

Locations

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Mohammad R Rayyan, master

Role: CONTACT

dr_rayyan@riyadh.edu.sa

+966508821318

Facility Contacts

Mohammad R Rayyan, master

Role: primary

dr_rayyan@riyadh.edu.sa

00966508821318

Other Identifiers

FUGRP/2016/115

Identifier Type: -

Identifier Source: org_study_id