Temporomandibular Joint Dysfunction SyndromeNCT02678715
Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy. Randomized Crossover Clinical Trial.
A study testing Solubrux®, Customized Appliance and Somatics® in people with Temporomandibular Joint Dysfunction Syndrome and Tooth Injuries, run by Eva Willaert Jiménez-Pajarero at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome, Tooth Injuries, Dental Occlusion, Traumatic
- What is being tested?
- Solubrux®, Customized Appliance and Somatics®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Being in a maintenance ECT program.
- Receiving ECT during the six months prior to the index episode.
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.
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.
Read the 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.
- Being tested
- Solubrux®, Customized Appliance, Somatics®
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Tooth Injuries, Dental Occlusion, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solubrux®Device
prefabricated device adaptable by temperature
Customized ApplianceDevice
customized device fabricated in the dental laboratory
Somatics®Device
standard device
| Study group | Role | What they receive |
|---|---|---|
| Sequence SB-CA-SM | Experimental | Solubrux®+ Customized Appliance + Somatics® Receives: Device: Solubrux®; Device: Customized Appliance; Device: Somatics® |
| Sequence SB-SM-CA | Experimental | Solubrux®+Somatics®+Customized Appliance Receives: Device: Solubrux®; Device: Customized Appliance; Device: Somatics® |
| Sequence CA-SB-SM | Experimental | Customized Appliance+Solubrux®+Somatics® Receives: Device: Solubrux®; Device: Customized Appliance; Device: Somatics® |
| Sequence CA-SM-SB | Experimental | Customized Appliance+Somatics®+Solubrux® Receives: Device: Solubrux®; Device: Customized Appliance; Device: Somatics® |
| Sequence SM-SB-CA | Experimental | Somatics®+Solubrux®+Customized Appliance Receives: Device: Solubrux®; Device: Customized Appliance; Device: Somatics® |
| Sequence SM-CA-SB | Experimental | Somatics®+ Customized Appliance+Solubrux® Receives: Device: Solubrux®; Device: Customized Appliance; Device: Somatics® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of six weeks
Secondary outcomes (3)
Dental fractures
Dichotomic qualitative variable assessed by inspection: 0= 0 fractures; 1=≥1 fractures
Measured: 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.
Measured: through study completion, an average of six weeks
Oral soft tissues injuries
Dichotomic qualitative variable assessed by inspection: 0= 0 lesions; 1=≥1 lesions
Measured: through study completion, an average of six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2022
- Study completionMay 2022
Why it stopped: Recruitment period too long
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eva Willaert Jiménez-Pajarero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eva Willaert Jiménez-Pajarero, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678715
- Sponsor's protocol ID
- AC089/15
- Status last verified
- May 2022
- First submitted
- 25 Jan 2016
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.
- ClinicalTrials.gov ID
- NCT02678715
- Acronym / sponsor ID
- AC089/15
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment period too long
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Eva Willaert Jiménez-PajareroUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence SB-CA-SM | Experimental | Device: Solubrux®, Device: Customized Appliance, Device: Somatics®Solubrux®+ Customized Appliance + Somatics® |
| Sequence SB-SM-CA | Experimental | Device: Solubrux®, Device: Customized Appliance, Device: Somatics®Solubrux®+Somatics®+Customized Appliance |
| Sequence CA-SB-SM | Experimental | Device: Solubrux®, Device: Customized Appliance, Device: Somatics®Customized Appliance+Solubrux®+Somatics® |
| Sequence CA-SM-SB | Experimental | Device: Solubrux®, Device: Customized Appliance, Device: Somatics®Customized Appliance+Somatics®+Solubrux® |
| Sequence SM-SB-CA | Experimental | Device: Solubrux®, Device: Customized Appliance, Device: Somatics®Somatics®+Solubrux®+Customized Appliance |
| Sequence SM-CA-SB | Experimental | Device: Solubrux®, Device: Customized Appliance, Device: Somatics®Somatics®+ Customized Appliance+Solubrux® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Being in a maintenance ECT program.
- Receiving ECT during the six months prior to the index episode.
- Pregnancy and lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solubrux®prefabricated device adaptable by temperature | Device | Sequence CA-SB-SM, Sequence CA-SM-SB, Sequence SB-CA-SM, Sequence SB-SM-CA, Sequence SM-CA-SB, Sequence SM-SB-CA |
| Customized Appliancecustomized device fabricated in the dental laboratory | Device | Sequence CA-SB-SM, Sequence CA-SM-SB, Sequence SB-CA-SM, Sequence SB-SM-CA, Sequence SM-CA-SB, Sequence SM-SB-CA |
| Somatics®standard device | Device | Sequence CA-SB-SM, Sequence CA-SM-SB, Sequence SB-CA-SM, Sequence SB-SM-CA, Sequence SM-CA-SB, Sequence SM-SB-CA |
Primary outcome
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)
3 secondary outcomes
Dental fractures
Time frame: through study completion, an average of six weeks
Dental mobility assessed by Periotest®
Time frame: through study completion, an average of six weeks
Oral soft tissues injuries
Time frame: through study completion, an average of six weeks
Results and safety
The study was stopped early (reason given: Recruitment period too long). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solubrux®, Customized Appliance and Somatics® in people with Temporomandibular Joint Dysfunction Syndrome and Tooth Injuries, run by Eva Willaert Jiménez-Pajarero at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment period too long). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
temporomandibular pain (time frame: through study completion, an average of six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.