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

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ClinicalTrials.gov Identifier: NCT02678715
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eva Willaert Jiménez-Pajarero, University of Barcelona

Tracking Information
First Submitted Date  ICMJE January 25, 2016
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date September 5, 2018
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02678715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
  • Dental fractures [ Time Frame: through study completion, an average of six weeks ]
    Dichotomic qualitative variable assessed by inspection: 0= 0 fractures; 1=≥1 fractures
  • Dental mobility assessed by Periotest® [ Time Frame: through study completion, an average of six weeks ]
    Continuous quantitative /qualitative ordinal assessed by an electronic instrument that uses an ultrasonically vibrating probe (Periotest®) to assess dental mobility.
  • Oral soft tissues injuries [ Time Frame: through study completion, an average of six weeks ]
    Dichotomic qualitative variable assessed by inspection: 0= 0 lesions; 1=≥1 lesions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy. Randomized Crossover Clinical Trial.
Official Title  ICMJE Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Temporomandibular Joint Dysfunction Syndrome
  • Tooth Injuries
  • Dental Occlusion, Traumatic
Intervention  ICMJE
  • Device: Solubrux®
    prefabricated device adaptable by temperature
  • Device: Customized Appliance
    customized device fabricated in the dental laboratory
  • Device: Somatics®
    standard device
Study Arms  ICMJE
  • Experimental: Sequence SB-CA-SM
    Solubrux®+ Customized Appliance + Somatics®
    Interventions:
    • Device: Solubrux®
    • Device: Customized Appliance
    • Device: Somatics®
  • Experimental: Sequence SB-SM-CA
    Solubrux®+Somatics®+Customized Appliance
    Interventions:
    • Device: Solubrux®
    • Device: Customized Appliance
    • Device: Somatics®
  • Experimental: Sequence CA-SB-SM
    Customized Appliance+Solubrux®+Somatics®
    Interventions:
    • Device: Solubrux®
    • Device: Customized Appliance
    • Device: Somatics®
  • Experimental: Sequence CA-SM-SB
    Customized Appliance+Somatics®+Solubrux®
    Interventions:
    • Device: Solubrux®
    • Device: Customized Appliance
    • Device: Somatics®
  • Experimental: Sequence SM-SB-CA
    Somatics®+Solubrux®+Customized Appliance
    Interventions:
    • Device: Solubrux®
    • Device: Customized Appliance
    • Device: Somatics®
  • Experimental: Sequence SM-CA-SB
    Somatics®+ Customized Appliance+Solubrux®
    Interventions:
    • Device: Solubrux®
    • Device: Customized Appliance
    • Device: Somatics®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2016)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eva Willaert, DDS,PhD +0034658383706 evawillaert@ub.edu
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678715
Other Study ID Numbers  ICMJE AC089/15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Eva Willaert Jiménez-Pajarero, University of Barcelona
Study Sponsor  ICMJE Eva Willaert Jiménez-Pajarero
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Barcelona
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP