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

Not Applicable

Terminated

• Conditions: Dental Occlusion, Traumatic; Tooth Injuries; Temporomandibular Joint Dysfunction Syndrome
• Interventions: Device: Solubrux®; Device: Customized Appliance; Device: Somatics®

• Registration Number: NCT02678715
• Lead Sponsor: Eva Willaert Jiménez-Pajarero

Brief 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.

Study Timeline

• Study First Submitted: 2016-01-25
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Status Verified: 2022-05
• Primary Completion: 2022-05
• Study Completion: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequence SM-CA-SB	Solubrux®	Somatics®+ Customized Appliance+Solubrux®
Sequence SM-CA-SB	Customized Appliance	Somatics®+ Customized Appliance+Solubrux®
Sequence SM-CA-SB	Somatics®	Somatics®+ Customized Appliance+Solubrux®
Sequence SB-CA-SM	Customized Appliance	Solubrux®+ Customized Appliance + Somatics®
Sequence SB-SM-CA	Somatics®	Solubrux®+Somatics®+Customized Appliance
Sequence CA-SB-SM	Solubrux®	Customized Appliance+Solubrux®+Somatics®
Sequence SB-CA-SM	Solubrux®	Solubrux®+ Customized Appliance + Somatics®
Sequence CA-SM-SB	Solubrux®	Customized Appliance+Somatics®+Solubrux®
Sequence SB-CA-SM	Somatics®	Solubrux®+ Customized Appliance + Somatics®
Sequence SB-SM-CA	Customized Appliance	Solubrux®+Somatics®+Customized Appliance
Sequence SB-SM-CA	Solubrux®	Solubrux®+Somatics®+Customized Appliance
Sequence CA-SB-SM	Customized Appliance	Customized Appliance+Solubrux®+Somatics®
Sequence CA-SB-SM	Somatics®	Customized Appliance+Solubrux®+Somatics®
Sequence CA-SM-SB	Customized Appliance	Customized Appliance+Somatics®+Solubrux®
Sequence SM-SB-CA	Customized Appliance	Somatics®+Solubrux®+Customized Appliance
Sequence SM-SB-CA	Somatics®	Somatics®+Solubrux®+Customized Appliance
Sequence CA-SM-SB	Somatics®	Customized Appliance+Somatics®+Solubrux®
Sequence SM-SB-CA	Solubrux®	Somatics®+Solubrux®+Customized Appliance

Primary Outcome Measures

Name	Time	Method
temporomandibular pain	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)

Secondary Outcome Measures

Name	Time	Method
Dental fractures	through study completion, an average of six weeks	Dichotomic qualitative variable assessed by inspection: 0= 0 fractures; 1=≥1 fractures
Dental mobility assessed by Periotest®	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.
Oral soft tissues injuries	through study completion, an average of six weeks	Dichotomic qualitative variable assessed by inspection: 0= 0 lesions; 1=≥1 lesions

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain