An interventional study of Solubrux® and Customized Appliance in Temporomandibular Joint Dysfunction Syndrome, Tooth Injuries and Dental Occlusion, Traumatic, sponsored by Eva Willaert Jiménez-Pajarero. Terminated at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by Eva Willaert Jiménez-Pajarero · Not applicable, Interventional, and Prevention
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.
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's enrollment of 4 is below the median of 60 across 470 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →This is the only study on the registry with Eva Willaert Jiménez-Pajarero as lead sponsor.
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Exclusion Criteria:
Solubrux®+ Customized Appliance + Somatics®
Device: Solubrux® · Device: Customized Appliance · Device: Somatics®
Solubrux®+Somatics®+Customized Appliance
Device: Solubrux® · Device: Customized Appliance · Device: Somatics®
Customized Appliance+Solubrux®+Somatics®
Device: Solubrux® · Device: Customized Appliance · Device: Somatics®
Customized Appliance+Somatics®+Solubrux®
Device: Solubrux® · Device: Customized Appliance · Device: Somatics®
Somatics®+Solubrux®+Customized Appliance
Device: Solubrux® · Device: Customized Appliance · Device: Somatics®
Somatics®+ Customized Appliance+Solubrux®
Device: Solubrux® · Device: Customized Appliance · Device: Somatics®
prefabricated device adaptable by temperature
customized device fabricated in the dental laboratory
standard device
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)
Time frame: through study completion, an average of six weeks
Dental fractures
Dichotomic qualitative variable assessed by inspection: 0= 0 fractures; 1=≥1 fractures
Time frame: through study completion, an average of six weeks
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.
Time frame: through study completion, an average of six weeks
Oral soft tissues injuries
Dichotomic qualitative variable assessed by inspection: 0= 0 lesions; 1=≥1 lesions
Time frame: through study completion, an average of six weeks
Plan to share: Undecided
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This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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