Study Stopped
Recruitment period too long
Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy. Randomized Crossover Clinical Trial.
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedMay 24, 2022
May 1, 2022
6.2 years
January 25, 2016
May 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (6)
Sequence SB-CA-SM
EXPERIMENTALSolubrux®+ Customized Appliance + Somatics®
Sequence SB-SM-CA
EXPERIMENTALSolubrux®+Somatics®+Customized Appliance
Sequence CA-SB-SM
EXPERIMENTALCustomized Appliance+Solubrux®+Somatics®
Sequence CA-SM-SB
EXPERIMENTALCustomized Appliance+Somatics®+Solubrux®
Sequence SM-SB-CA
EXPERIMENTALSomatics®+Solubrux®+Customized Appliance
Sequence SM-CA-SB
EXPERIMENTALSomatics®+ Customized Appliance+Solubrux®
Interventions
prefabricated device adaptable by temperature
customized device fabricated in the dental laboratory
standard device
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Being in a maintenance ECT program.
- Receiving ECT during the six months prior to the index episode.
- Pregnancy and lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- DDS, PhD
Study Record Dates
First Submitted
January 25, 2016
First Posted
February 10, 2016
Study Start
February 1, 2016
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
May 24, 2022
Record last verified: 2022-05