TerminatedNot Applicable

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

Stopped: Recruitment period too long

Spain4 participantsStarted 2016-02

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

temporomandibular pain

Timeframe: through study completion, an average of six weeks

Trial details

NCT IDNCT02678715

SponsorEva Willaert Jiménez-Pajarero

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05

View on ClinicalTrials.gov More Temporomandibular Joint Dysfunction Syndrome trials