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

Temporomandibular Joint Dysfunction Syndrome Clinical Trial

Official title:

Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02678715
• Other study ID #: AC089/15
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 2022

Study information

• Verified date: May 2022
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Solubrux®
prefabricated device adaptable by temperature
• Customized Appliance
customized device fabricated in the dental laboratory
• Somatics®
standard device

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Eva Willaert Jiménez-Pajarero

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dental fractures	Dichotomic qualitative variable assessed by inspection: 0= 0 fractures; 1==1 fractures	through study completion, an average of six weeks
Secondary	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
Secondary	Oral soft tissues injuries	Dichotomic qualitative variable assessed by inspection: 0= 0 lesions; 1==1 lesions	through study completion, an average of six weeks