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Trial record 26 of 30 for:    Temporomandibular Joint Disorders | Recruiting Studies

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 : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Eva Willaert Jiménez-Pajarero, University of Barcelona

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.


Condition or disease Intervention/treatment Phase
Temporomandibular Joint Dysfunction Syndrome Tooth Injuries Dental Occlusion, Traumatic Device: Solubrux® Device: Customized Appliance Device: Somatics® Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.
Study Start Date : February 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Sequence SB-CA-SM
Solubrux®+ Customized Appliance + Somatics®
Device: Solubrux®
prefabricated device adaptable by temperature

Device: Customized Appliance
customized device fabricated in the dental laboratory

Device: Somatics®
standard device

Experimental: Sequence SB-SM-CA
Solubrux®+Somatics®+Customized Appliance
Device: Solubrux®
prefabricated device adaptable by temperature

Device: Customized Appliance
customized device fabricated in the dental laboratory

Device: Somatics®
standard device

Experimental: Sequence CA-SB-SM
Customized Appliance+Solubrux®+Somatics®
Device: Solubrux®
prefabricated device adaptable by temperature

Device: Customized Appliance
customized device fabricated in the dental laboratory

Device: Somatics®
standard device

Experimental: Sequence CA-SM-SB
Customized Appliance+Somatics®+Solubrux®
Device: Solubrux®
prefabricated device adaptable by temperature

Device: Customized Appliance
customized device fabricated in the dental laboratory

Device: Somatics®
standard device

Experimental: Sequence SM-SB-CA
Somatics®+Solubrux®+Customized Appliance
Device: Solubrux®
prefabricated device adaptable by temperature

Device: Customized Appliance
customized device fabricated in the dental laboratory

Device: Somatics®
standard device

Experimental: Sequence SM-CA-SB
Somatics®+ Customized Appliance+Solubrux®
Device: Solubrux®
prefabricated device adaptable by temperature

Device: Customized Appliance
customized device fabricated in the dental laboratory

Device: Somatics®
standard device




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Dental fractures [ Time Frame: through study completion, an average of six weeks ]
    Dichotomic qualitative variable assessed by inspection: 0= 0 fractures; 1=≥1 fractures

  2. 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.

  3. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678715


Contacts
Contact: Eva Willaert, DDS,PhD +0034658383706 evawillaert@ub.edu

Locations
Spain
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Aida de Arriba, MD    +0034932607922// 932607661    adearriba@bellvitgehospital.cat   
Contact: Carla Zamora, DDS    +0034606611341    carla.zamoraolave@gmail.com   
Principal Investigator: Eva Willaert, DDS,PhD         
Sub-Investigator: Maria Peraire, DDS,PhD         
Sub-Investigator: Carla Zamora, DDS         
Sub-Investigator: Mikel Urretavizcaya, MD, PhD         
Sub-Investigator: Aida de Arriba, MD         
Sub-Investigator: Jordi Martinez, DDS, PhD         
Sponsors and Collaborators
Eva Willaert Jiménez-Pajarero

Responsible Party: Eva Willaert Jiménez-Pajarero, DDS, PhD, University of Barcelona
ClinicalTrials.gov Identifier: NCT02678715     History of Changes
Other Study ID Numbers: AC089/15
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Injuries
Dental Occlusion, Traumatic
Myofascial Pain Syndromes
Wounds and Injuries
Malocclusion