Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy. Randomized Crossover Clinical Trial.

May 17, 2022 updated by: Eva Willaert Jiménez-Pajarero

Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.

This observer-blind crossover intervention study aims to determine the most effective type of device as oral mouthguard in modified-Electroconvulsive Therapy (m-ECT) comparing three types of devices: standard, prefabricated and manufactured in the dental laboratory.

Patients from the ECT Unit of Psychiatric Department of the University Hospital of Bellvitge will use the three devices at a random sequence during the twelve treatment sessions, so each device (A, B, C) will be used for two weeks, that is, for four consecutive sessions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Treatment with electroconvulsive therapy will involve the application of 12 m-ECT sessions at the rate of two sessions for six weeks according to the protocol established in the ECT Unit of the Department of Psychiatry at the University Hospital of Bellvitge.

Two devices, SB and CA, will be prepared for each patient and placed in mouth before anesthesia by one operator. This operator will assign a randomized sequence of use of the three devices (SB, CA or SM). Device SM will be the sole protector that will be placed after the anesthesia by nurse.

The outcome assessor will the scans pre- and post-session m-ECT and collect data, accede the surgery room before the session with the patient conscious and perform the exploration. This outcome assessor will leave the operating room during the procedure for the application of m-ECT an come back an hour later for the post-examination session.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients should have an intellectual level that allows a proper communication and must agree to cooperate in all tests and exams required by the study protocol.
  • Obtaining written informed consent for participating in the project (model consent form)
  • The patient must have enough teeth in the upper arch or being a carrier of a stable removable prosthesis.

Exclusion Criteria:

  • Being in a maintenance ECT program.
  • Receiving ECT during the six months prior to the index episode.
  • Pregnancy and lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence SB-CA-SM
Solubrux®+ Customized Appliance + Somatics®
Device: Solubrux®
prefabricated device adaptable by temperature
Device: Customized Appliance
customized device fabricated in the dental laboratory
Device: Somatics®
standard device
Experimental: Sequence SB-SM-CA
Solubrux®+Somatics®+Customized Appliance
Device: Solubrux®
prefabricated device adaptable by temperature
Device: Customized Appliance
customized device fabricated in the dental laboratory
Device: Somatics®
standard device
Experimental: Sequence CA-SB-SM
Customized Appliance+Solubrux®+Somatics®
Device: Solubrux®
prefabricated device adaptable by temperature
Device: Customized Appliance
customized device fabricated in the dental laboratory
Device: Somatics®
standard device
Experimental: Sequence CA-SM-SB
Customized Appliance+Somatics®+Solubrux®
Device: Solubrux®
prefabricated device adaptable by temperature
Device: Customized Appliance
customized device fabricated in the dental laboratory
Device: Somatics®
standard device
Experimental: Sequence SM-SB-CA
Somatics®+Solubrux®+Customized Appliance
Device: Solubrux®
prefabricated device adaptable by temperature
Device: Customized Appliance
customized device fabricated in the dental laboratory
Device: Somatics®
standard device
Experimental: Sequence SM-CA-SB
Somatics®+ Customized Appliance+Solubrux®
Device: Solubrux®
prefabricated device adaptable by temperature
Device: Customized Appliance
customized device fabricated in the dental laboratory
Device: Somatics®
standard device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
temporomandibular pain
Time Frame: through study completion, an average of six weeks
Continuous quantitative variable assessed by visual analogue scale (VAS) of 100 mm in length, marking the end as no pain (source) or the worst pain imaginable (final)
through study completion, an average of six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental fractures
Time Frame: through study completion, an average of six weeks
Dichotomic qualitative variable assessed by inspection: 0= 0 fractures; 1=≥1 fractures
through study completion, an average of six weeks
Dental mobility assessed by Periotest®
Time Frame: through study completion, an average of six weeks
Continuous quantitative /qualitative ordinal assessed by an electronic instrument that uses an ultrasonically vibrating probe (Periotest®) to assess dental mobility.
through study completion, an average of six weeks
Oral soft tissues injuries
Time Frame: through study completion, an average of six weeks
Dichotomic qualitative variable assessed by inspection: 0= 0 lesions; 1=≥1 lesions
through study completion, an average of six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eva Willaert Jiménez-Pajarero

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC089/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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