NCT02938364

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

October 25, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

2.1 years

First QC Date

October 17, 2016

Last Update Submit

April 10, 2018

Conditions

Gagging

Outcome Measures

Primary Outcomes (1)

  • Change 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)

    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

Secondary Outcomes (1)

  • Change from baseline Visual Analogue Scale scoring of patient's satisfaction during impression making

    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

Study Arms (3)

Earplugs

EXPERIMENTAL

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

Acupressure

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

EarplugsOTHER

Plastic earplugs on both ears

Earplugs
AcupressureOTHER

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

Acupressure
PlaceboOTHER

Non pressure bands put on the wrists of the participant

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, 11681, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Gagging

Interventions

Ear Protective DevicesAcupressure

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personal Protective EquipmentProtective DevicesEquipment and SuppliesProtective ClothingClothingManufactured MaterialsTechnology, Industry, and AgricultureTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Mohammad R Rayyan, master

    Riyadh Colleges of Dentistry and Pharmacy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad R Rayyan, master

CONTACT

+966508821318dr_rayyan@riyadh.edu.sa

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

October 25, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

April 12, 2018

Record last verified: 2018-04

Locations

SA(1)