Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- temporomandibular pain
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sequence SB-CA-SM
Solubrux®+ Customized Appliance + Somatics®
Intervention: Solubrux® (Device)
Sequence SB-CA-SM
Solubrux®+ Customized Appliance + Somatics®
Intervention: Customized Appliance (Device)
Sequence SB-CA-SM
Solubrux®+ Customized Appliance + Somatics®
Intervention: Somatics® (Device)
Sequence SB-SM-CA
Solubrux®+Somatics®+Customized Appliance
Intervention: Solubrux® (Device)
Sequence SB-SM-CA
Solubrux®+Somatics®+Customized Appliance
Intervention: Customized Appliance (Device)
Sequence SB-SM-CA
Solubrux®+Somatics®+Customized Appliance
Intervention: Somatics® (Device)
Sequence CA-SB-SM
Customized Appliance+Solubrux®+Somatics®
Intervention: Solubrux® (Device)
Sequence CA-SB-SM
Customized Appliance+Solubrux®+Somatics®
Intervention: Customized Appliance (Device)
Sequence CA-SB-SM
Customized Appliance+Solubrux®+Somatics®
Intervention: Somatics® (Device)
Sequence CA-SM-SB
Customized Appliance+Somatics®+Solubrux®
Intervention: Solubrux® (Device)
Sequence CA-SM-SB
Customized Appliance+Somatics®+Solubrux®
Intervention: Customized Appliance (Device)
Sequence CA-SM-SB
Customized Appliance+Somatics®+Solubrux®
Intervention: Somatics® (Device)
Sequence SM-SB-CA
Somatics®+Solubrux®+Customized Appliance
Intervention: Solubrux® (Device)
Sequence SM-SB-CA
Somatics®+Solubrux®+Customized Appliance
Intervention: Customized Appliance (Device)
Sequence SM-SB-CA
Somatics®+Solubrux®+Customized Appliance
Intervention: Somatics® (Device)
Sequence SM-CA-SB
Somatics®+ Customized Appliance+Solubrux®
Intervention: Solubrux® (Device)
Sequence SM-CA-SB
Somatics®+ Customized Appliance+Solubrux®
Intervention: Customized Appliance (Device)
Sequence SM-CA-SB
Somatics®+ Customized Appliance+Solubrux®
Intervention: Somatics® (Device)
Outcomes
Primary Outcomes
temporomandibular pain
Time Frame: 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 Outcomes
- Dental fractures(through study completion, an average of six weeks)
- Dental mobility assessed by Periotest®(through study completion, an average of six weeks)
- Oral soft tissues injuries(through study completion, an average of six weeks)
Investigators
Eva Willaert Jiménez-Pajarero
DDS, PhD
University of Barcelona