RCT of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis
TMJ_Dist
Randomised Controlled Clinical Trial of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis
1 other identifier
interventional
40
1 country
1
Brief Summary
Articular Disc Displacements are the most common TMJ arthropathy and the articular distraction technique is one of the most common therapeutic resources. It is a technique almost exclusively performed by the physiotherapist and / or dentist, with repeated applications over an extended period of treatment, that can reach several weeks or months, difficult to perform manually by the patient on an ambulatory basis. Currently there are no ambulatory mandibular exercise devices that aim to execute articular distraction. Thus, the objective of this work was to study, design and develop a device capable of performing and / or assisting patients in the articular distraction maneuver.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
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
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 3, 2018
CompletedFirst Posted
Study publicly available on registry
November 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedNovember 13, 2018
November 1, 2018
1.1 years
November 3, 2018
November 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change of Pain at Rest (Visual Analogic Scale from 0-10)
Mandibular Pain at Rest evaluated in a 0-10 (VAS) Visual Analogic Scale being 0 ´´No pain´´ and 10 ´´The worst pain ever´´
0 day, 7 days, 14 days, 28 days and 90 days of the study
Change of Pain in Function (Visual Analogic Scale from 0-10)
Mandibular Pain in Function evaluated in a 0-10 (VAS) Visual Analogic Scale being 0 ´´No pain´´ and 10 ´´The worst pain ever´´
0 day, 7 days, 14 days, 28 days and 90 days of the study
Change of Subjective chewing efficiency
Subjective chewing efficiency (evaluated in a 0-10 Visual Analogic Scale with 0 being ´´the worst efficiency ever´´ and 10 ´´the best efficiency ever´´)
0 day, 7 days, 14 days, 28 days and 90 days of the study
Secondary Outcomes (2)
Change in the Perceived subjective treatment effectiveness
0 day, 7 days, 14 days, 28 days and 90 days of the study
Change of Jaw range of motion function in millimetres
0 day, 7 days, 14 days, 28 days and 90 days of the study
Study Arms (2)
Control Group
ACTIVE COMPARATORControl group of conventional therapy with manual distraction performed by the physiotherapist in the office (active comparator)
Distractor Test Group
EXPERIMENTALTest group with manual distraction performed by the physiotherapist in the office and the condylar distraction performed by the patient with the condylar distraction device in an ambulatory basis.
Interventions
The patients will perform condylar distraction with the condylar distraction device in an ambulatory basis.
Conventional Physical Therapy, performed in office by a experienced physical therapist for the TMJ condition.
Eligibility Criteria
You may qualify if:
- Patients with a minimum of 18 years of age
- Diagnosis by the Research Diagnostic criteria of Temporomandibular Disorders (RDC / TMD), of disk displacement with or without reduction, with or without opening limitation (Group IIa, IIb or IIc) and atralgia (Group IIIa)
- Clinical indication for the proposed treatment
You may not qualify if:
- Patients \<18 years
- Pregnant patients
- Absence of posterior teeth (not rehabilitated), advanced periodontal disease in the posterior teeth or patients with total dentures that compromise the use of the device
- Diagnosis by the Research Diagnostic criteria of Temporomandibular Disorders (RDC / TMD), of Osteoarthritis (Group IIIb) and Osteoarthrosis (IIIc)
- Presence of contralateral TMJ pathology, with no clinical indication for the proposed treatment, limiting the patient's mandibular mobility and influencing patient rehabilitation (eg, ankylosis or myofibrotic contracture)
- History of surgery at the ATM
- Patients with systemic disease that may affect the TMJ
- Aphasia, dementia, or known psychiatric or physical comorbidity that may interfere with communication or compliance during the rehabilitation process.
- Patients blind, illiterate or with reduced cognitive abilities that may interfere with communication or compliance during the rehabilitation process.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fonseca, Juliolead
Study Sites (1)
OrisClinic - Júlio Fonseca
Coimbra, 3000-041, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Júlio Fonseca
Dr.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The Outcomes Assessor, or secondary investigator does nor have the knowlegde of the group of patients that is being evaluated.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor (Dentistry); Principal Investigator
Study Record Dates
First Submitted
November 3, 2018
First Posted
November 9, 2018
Study Start
May 1, 2018
Primary Completion
June 1, 2019
Study Completion
June 30, 2019
Last Updated
November 13, 2018
Record last verified: 2018-11