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

Eva Willaert Jiménez-Pajarero

Status: Terminated

Conditions: Tooth Injuries; Temporomandibular Joint Dysfunction Syndrome; Dental Occlusion, Traumatic

Treatments: Device: Customized Appliance; Device: Somatics®; Device: Solubrux®

Study type: Interventional

Funder types: Other

Identifiers

NCT02678715

AC089/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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4 participants in 6 patient groups

Sequence SB-CA-SM

Experimental group

Description:

Solubrux®+ Customized Appliance + Somatics®

Treatment:

Device: Solubrux®

Device: Somatics®

Device: Customized Appliance

Sequence SB-SM-CA

Experimental group

Description:

Solubrux®+Somatics®+Customized Appliance

Treatment:

Device: Solubrux®

Device: Somatics®

Device: Customized Appliance

Sequence CA-SB-SM

Experimental group

Description:

Customized Appliance+Solubrux®+Somatics®

Treatment:

Device: Solubrux®

Device: Somatics®

Device: Customized Appliance

Sequence CA-SM-SB

Experimental group

Description:

Customized Appliance+Somatics®+Solubrux®

Treatment:

Device: Solubrux®

Device: Somatics®

Device: Customized Appliance

Sequence SM-SB-CA

Experimental group

Description:

Somatics®+Solubrux®+Customized Appliance

Treatment:

Device: Solubrux®

Device: Somatics®

Device: Customized Appliance

Sequence SM-CA-SB

Experimental group

Description:

Somatics®+ Customized Appliance+Solubrux®

Treatment:

Device: Solubrux®

Device: Somatics®

Device: Customized Appliance