Stress, PsychologicalNCT01376973
Efficiency of Two Occlusal Splints on TMD Treatment of Police Officers
An observational study of Stress, Psychological and Temporomandibular Disorder, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Stress is an important cause factor of temporomandibular disorder (TMD) and Police Officers are exposed to stress. Aim of the study was to evaluate clinical and electromyographically the effect of two different occlusal splints on police officers with TMD Read more about this study
- Who is it for?
- Ages 28 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Temporomandibular Disorder
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Nov 2008
- Phase
- Observational
- 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 28 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: police officers of the São Paulo State - Brazil filled up the Axis II of Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) with TMD symptoms.
Who may be able to join
- Axis II of Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) with TMD symptoms.
Who cannot join
- systemic diseases like fibromyalgia, arthritis, arthrosis or osteoporosis, historical of TMJ (temporomandibular joint) surgery or TMD treatment, dental prosthesis, loss of more than two posterior teeth (except third molars and teeth extracted for orthodontic reasons), incomplete dentition with spaces in the arch (except third molars),volunteers with orthodontic and/or orthopedic appliances, with mandible and/or maxilla fractures, vertebrae or medullar canal stenosis, taking anti-inflammatory, analgesic and/or muscle-relaxing drugs, in otologic treatment or without compromise with the investigation. Who presented myogenic or mixed TMD, TMJ pain for at least three months and joint tenderness on palpation on at least one side was invited to remain in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Two Occlusal Splints on TMD Treatment: Randomised Clinical Trial
Stress is an important cause factor of temporomandibular disorder (TMD) and Police Officers are exposed to stress. Aim of the study was to evaluate clinical and electromyographically the effect of two different occlusal splints on police officers with TMD
Read the detailed description
After the approval by the Human Research Ethics Committee of the Piracicaba Dental School by the register number 189/03, 905 police officers of the São Paulo State - Brazil filled up the Axis II of Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and 256 volunteers were selected with TMD symptoms. Afterward the volunteers were submitted to the Axis I of RDC (clinical examination) and were excluded who presented systemic diseases like fibromyalgia, arthritis, arthrosis or osteoporosis, historical of TMJ (temporomandibular joint) surgery or TMD treatment, dental prosthesis, loss of more than two posterior teeth (except third molars and teeth extracted for orthodontic reasons), incomplete dentition with spaces in the arch (except third molars),volunteers with orthodontic and/or orthopedic appliances, with mandible and/or maxilla fractures, vertebrae or medullar canal stenosis, taking anti-inflammatory, analgesic and/or muscle-relaxing drugs, in otologic treatment or without compromise with the investigation. Who presented myogenic or mixed TMD, TMJ pain for at least three months and joint tenderness on palpation on at least one side was invited to remain in the study.
According to the exclusion and inclusion criteria above presented were selected 30 volunteers (15 women and 15 men), average age of 29 years, with diagnosis indicative of myogenic or mixed TMD.
The volunteers were randomized divided into three different groups with 10 persons per group using a stratification method performed by computerized table that placed the subjects into different groups according to the occlusal splints. Group A: Not received any oral device (Control); Group B: Used Michigan Occlusal Splint (MOS);Group C: Used Planas Oral Appliance (POA).
Each one of the 30 volunteers filled out the Visual Analog of Pain Scale (VAPS) to evaluate the muscle pain sensibility and were clinically examined according to the Axis I of RDC, always by the same examiner, in the morning, before and four weeks after the beginning of the experiment.
OCCLUSAL SPLINTS Twenty volunteers used two different occlusal splints during four weeks only while sleeping.
Volunteers were oriented to not communicate each other during treatment to keep unknown the differences between occlusal splints and about the control group.
Instrumentation Electromyographic records were performed on temporal, masseter and suprahyoid muscles before and four weeks after used the occlusal splints. Volunteers remained seated, Frankfurt's plane parallel to the floor, looking toward the front, feet on the floor, legs at 90º angle and hands resting on thighs. Occlusal splints were removed during EMG records.
All EMG records were obtained by Lynx Data Acquisition System (MCS1000-V2) with 16 channels, 12 bits resolution of dynamic range, Butterworth filter, 500 Hz pass band, high pass filter of 20 Hz and gain of 2000 times. The Software Aqdados, version 5 (Lynx) was used, with a sampling frequency of 1000 Hz and simple differential active surface electrodes with entrance impedance of 10 ohms CMRR (Common Mode Rejection Reason) of 80 dB, impedance of 1012 ohms and gain of 20 times. A reference electrode was positioned on the sternum bone of the volunteers.
Surface electrodes were placed bilaterally on the masseter, temporal and suprahyoid muscles, according to previous muscles palpation and muscle function test. In all cases electrodes were fixed on the previously cleaned skin by alcohol and attached by double-side adhesive tape (Castroflorio et al., 2004) in the centre of the muscular belly, parallel to the muscle fibers with the silver bars perpendicular to their direction to maximize signal capture and minimize noise interference.
In three different moments the EMG records were performed. First: 5 seconds of muscle resting. Second: maximal voluntary contraction (MVC), biting bilaterally two pieces of elastic cord (no.201) of 2.5-cm length. Third: MVC for the suprahyoid muscle at maximal mouth opening (MMO). Signals were normalized by the mean of the RMS (Root Mean Square) of three MVC measurements. Each EMG exam was performed after 3 minutes of resting for physiological recovery avoiding muscle fatigue.
- Conditions
- Stress, Psychological, Temporomandibular Disorder
- Keywords
- stress, temporomandibular disorders.
- Medical subject headings
- Stress, Psychological, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group A | Not received any oral device (Control) | |
| Group B and Group C | Group B - Used Michigan Occlusal Splint (MOS); Group C - Used Planas Oral Appliance (POA). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMar 2008
- Primary completionMay 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- P F Caria, PhD, Study chair, University of Campinas - UNICAMP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376973
- Sponsor's protocol ID
- 189/03
- Status last verified
- Jun 2011
- First submitted
- 16 Jun 2011
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Two Occlusal Splints on TMD Treatment: Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01376973
- Acronym / sponsor ID
- 189/03
- Conditions
- Stress, Psychological, Temporomandibular Disorder
- Keywords
- stress, temporomandibular disorders.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Mar 2008
- Primary completion
- May 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 Jun 2011 (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.
Stress is an important cause factor of temporomandibular disorder (TMD) and Police Officers are exposed to stress. Aim of the study was to evaluate clinical and electromyographically the effect of two different occlusal splints on police officers with TMD
Detailed description
After the approval by the Human Research Ethics Committee of the Piracicaba Dental School by the register number 189/03, 905 police officers of the São Paulo State - Brazil filled up the Axis II of Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and 256 volunteers were selected with TMD symptoms. Afterward the volunteers were submitted to the Axis I of RDC (clinical examination) and were excluded who presented systemic diseases like fibromyalgia, arthritis, arthrosis or osteoporosis, historical of TMJ (temporomandibular joint) surgery or TMD treatment, dental prosthesis, loss of more than two posterior teeth (except third molars and teeth extracted for orthodontic reasons), incomplete dentition with spaces in the arch (except third molars),volunteers with orthodontic and/or orthopedic appliances, with mandible and/or maxilla fractures, vertebrae or medullar canal stenosis, taking anti-inflammatory, analgesic and/or muscle-relaxing drugs, in otologic treatment or without compromise with the investigation. Who presented myogenic or mixed TMD, TMJ pain for at least three months and joint tenderness on palpation on at least one side was invited to remain in the study.
According to the exclusion and inclusion criteria above presented were selected 30 volunteers (15 women and 15 men), average age of 29 years, with diagnosis indicative of myogenic or mixed TMD.
The volunteers were randomized divided into three different groups with 10 persons per group using a stratification method performed by computerized table that placed the subjects into different groups according to the occlusal splints. Group A: Not received any oral device (Control); Group B: Used Michigan Occlusal Splint (MOS);Group C: Used Planas Oral Appliance (POA).
Each one of the 30 volunteers filled out the Visual Analog of Pain Scale (VAPS) to evaluate the muscle pain sensibility and were clinically examined according to the Axis I of RDC, always by the same examiner, in the morning, before and four weeks after the beginning of the experiment.
OCCLUSAL SPLINTS Twenty volunteers used two different occlusal splints during four weeks only while sleeping.
Volunteers were oriented to not communicate each other during treatment to keep unknown the differences between occlusal splints and about the control group.
Instrumentation Electromyographic records were performed on temporal, masseter and suprahyoid muscles before and four weeks after used the occlusal splints. Volunteers remained seated, Frankfurt's plane parallel to the floor, looking toward the front, feet on the floor, legs at 90º angle and hands resting on thighs. Occlusal splints were removed during EMG records.
All EMG records were obtained by Lynx Data Acquisition System (MCS1000-V2) with 16 channels, 12 bits resolution of dynamic range, Butterworth filter, 500 Hz pass band, high pass filter of 20 Hz and gain of 2000 times. The Software Aqdados, version 5 (Lynx) was used, with a sampling frequency of 1000 Hz and simple differential active surface electrodes with entrance impedance of 10 ohms CMRR (Common Mode Rejection Reason) of 80 dB, impedance of 1012 ohms and gain of 20 times. A reference electrode was positioned on the sternum bone of the volunteers.
Surface electrodes were placed bilaterally on the masseter, temporal and suprahyoid muscles, according to previous muscles palpation and muscle function test. In all cases electrodes were fixed on the previously cleaned skin by alcohol and attached by double-side adhesive tape (Castroflorio et al., 2004) in the centre of the muscular belly, parallel to the muscle fibers with the silver bars perpendicular to their direction to maximize signal capture and minimize noise interference.
In three different moments the EMG records were performed. First: 5 seconds of muscle resting. Second: maximal voluntary contraction (MVC), biting bilaterally two pieces of elastic cord (no.201) of 2.5-cm length. Third: MVC for the suprahyoid muscle at maximal mouth opening (MMO). Signals were normalized by the mean of the RMS (Root Mean Square) of three MVC measurements. Each EMG exam was performed after 3 minutes of resting for physiological recovery avoiding muscle fatigue.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | –Not received any oral device (Control) |
| Group B and Group C | – | –Group B - Used Michigan Occlusal Splint (MOS); Group C - Used Planas Oral Appliance (POA). |
Who may qualify
- Ages
- 28 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- police officers of the São Paulo State - Brazil filled up the Axis II of Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) with TMD symptoms.
Key inclusion criteria (1 listed)
- Axis II of Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) with TMD symptoms.
Key exclusion criteria (1 listed)
- systemic diseases like fibromyalgia, arthritis, arthrosis or osteoporosis, historical of TMJ (temporomandibular joint) surgery or TMD treatment, dental prosthesis, loss of more than two posterior teeth (except third molars and teeth extracted for orthodontic reasons), incomplete dentition with spaces in the arch (except third molars),volunteers with orthodontic and/or orthopedic appliances, with mandible and/or maxilla fractures, vertebrae or medullar canal stenosis, taking anti-inflammatory, analgesic and/or muscle-relaxing drugs, in otologic treatment or without compromise with the investigation. Who presented myogenic or mixed TMD, TMJ pain for at least three months and joint tenderness on palpation on at least one side was invited to remain in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
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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.
P F Caria, PhD study chair
University of Campinas - UNICAMP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Psychological and Temporomandibular Disorder, run by University of Campinas, Brazil at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jun 2011. 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 Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 20 Jun 2011.