Clinical trial NCT02678715: Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy. Randomized Crossover Clinical Trial.
Official title: Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Tooth Injuries
Dental Occlusion, Traumatic
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: temporomandibular pain
timeFrame: through study completion, an average of six weeks
Secondary outcomes:
measure: Dental fractures
timeFrame: through study completion, an average of six weeks
measure: Dental mobility assessed by Periotest®
timeFrame: through study completion, an average of six weeks
measure: Oral soft tissues injuries
timeFrame: through study completion, an average of six weeks
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
References: