NCT02678715

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

Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Eva Willaert Jiménez-Pajarero · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

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

Interventions

Type	Name	Description
DEVICE	Solubrux®	prefabricated device adaptable by temperature
DEVICE	Customized Appliance	customized device fabricated in the dental laboratory
DEVICE	Somatics®	standard device

Timeline

• Start date: 2016-02-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2016-02-10
• Last updated: 2022-05-24

Locations

1 site across 1 country: Spain