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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2022-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Temporomandibular Joint Dysfunction Syndrome Tooth Injuries Dental Occlusion, Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Intervention Type DEVICE

standard device

Interventions

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Solubrux®

prefabricated device adaptable by temperature

Intervention Type DEVICE

Customized Appliance

customized device fabricated in the dental laboratory

Intervention Type DEVICE

Somatics®

standard device

Intervention Type DEVICE

Eligibility Criteria

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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.