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

Study Overview
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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.

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.

Official Title
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Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.

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

Intervention / Treatment
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* Device: Solubrux®
* Device: Customized Appliance
* Device: Somatics®


Participation Criteria
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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. Exclusion Criteria: Being in a maintenance ECT program. Receiving ECT during the six months prior to the index episode. Pregnancy and lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| temporomandibular pain | 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 | 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® | 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 | Dichotomic qualitative variable assessed by inspection: 0= 0 lesions; 1=≥1 lesions | through study completion, an average of six weeks |