Temporomandibular DisordersNCT02380105
Effectiveness of a Counseling Program for Temporomandibular Disorders (TMD) Treatment
A study testing Counseling and Interocclusal Appliances in people with Temporomandibular Disorders, run by Universidade Federal do Rio Grande do Norte.
Trial summary
This study aims to evaluate the effectiveness of counseling on pain, function and well-fare outcomes for the management of patients with temporomandibular disorder (TMD). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Counseling and Interocclusal Appliances
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to May 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female individuals
- Positive diagnosis of TMD according to RDC/TMD
- Presence of pain in the orofacial region persisting for at least a week of at least moderate intensity, according to the Numeric Scale of pain
Who cannot join
- TMD treatment for ongoing pain
- Presence of pulpal or periodontal disease
- Orthodontic treatment in progress
- Daily use of analgesics, antidepressants or muscle relaxants
- History of radiotherapy to the head and neck, or any adverse systemic condition that may favor presentation of symptoms involved
About this study
Official title: Effectiveness of a Counseling Program for TMD Treatment
This study aims to evaluate the effectiveness of counseling on pain, function and well-fare outcomes for the management of patients with temporomandibular disorder (TMD).
Read the detailed description
In this study, 51 patients were allocated to one of the research groups. In Group I, it was instituted counseling therapy. For Group II was conducted treatment as usual with occlusal splint. Patients were followed for returns at 7, 15, 30 and 60 days after baseline. At baseline, all patients were examined and assessed Research Diagnostic Criteria/Temporomandibular Disorder (RDC/TMD form). In addition, the patients were referred for specific treatment according to the group to which belonged. In each session, patients were also surveyed about pain intensity using a Numeric Scale. To analyze the impact of pain on quality of life, Oral Health Impact Profile (OHIP-14) questionnaire was used.
- Conditions
- Temporomandibular Disorders
- Being tested
- Counseling, Interocclusal Appliances
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Patients were informed of their condition and possible etiological factors contributing to the pathology. They were also educated about the postural rest position of the mandible and instructed to perform bilateral chewing and not overload the temporomandibular joint and masticatory muscles. Techniques to relieve pain and tension were taught to correct postural habits, food and sleep irregularities. The patients received written instructions for future reference, as a way of reinforcing the information provided during the initial consultation.
Interocclusal AppliancesDevice
Patients were treated using interocclusal appliances
| Study group | Role | What they receive |
|---|---|---|
| Counseling Group | Experimental | Patients allocated to the counseling group (Group I) were informed about possible etiological factors and educated to not overload the temporomandibular joint and masticatory muscles. Techniques to relieve pain and tension were taught to correct postural habits, food and sleep irregularities. The patients received written instructions, as a way of reinforcing the information provided during the initial consultation. In subsequent returns at 7, 15, 30 and 60 days of follow-up, the instructions were given again and patients were asked whether they had detected any habits related to the initiation and maintenance of painful symptoms of TMD, as a way to further highlight the association between the presence of these harmful behaviors and the worsening signs and symptoms of TMD. Receives: Behavioral: Counseling |
| Splint Group | Active comparator | Patients allocated to the splint group (Group II) were treated using interocclusal appliances, according to the following protocol: At baseline, an anterior bite plate (front-plateau) was made from acrylic resin that was placed in the maxillary arch to include the the canine to canine region and promote the disocclusion of the posterior teeth. Patients were instructed to use the device for 24 hours, interspersed with rests of equal length during the first week. After 7 days, the device was removed. A hard splint was then made. At 30 days of follow-up, the splint was fitted and the patients were also asked to use it when they were sleeping. Receives: Device: Interocclusal Appliances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as measured by Visual Analogue Scale (VAS)
Visual Analogue Scale
Measured: Baseline, 7, 15, 30, 60 days
Secondary outcomes (2)
Quality of life measured by Oral Health Impact Profile (OHIP)
Oral Health Impact Profile
Measured: Baseline, 7, 15, 30, 60 days
Functional Evaluation measured by TemporoMandibular Index (TMI)
Temporomandibular Index
Measured: Baseline, 7, 15, 30, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Falcão Carvalho Porto de Freitas, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380105
- Sponsor's protocol ID
- 200/11-P CEP/UFRN
- Status last verified
- Feb 2015
- First submitted
- 14 Nov 2014
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Counseling Program for TMD Treatment
- ClinicalTrials.gov ID
- NCT02380105
- Acronym / sponsor ID
- 200/11-P CEP/UFRN
- Conditions
- Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Mar 2015 (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 study aims to evaluate the effectiveness of counseling on pain, function and well-fare outcomes for the management of patients with temporomandibular disorder (TMD).
Detailed description
In this study, 51 patients were allocated to one of the research groups. In Group I, it was instituted counseling therapy. For Group II was conducted treatment as usual with occlusal splint. Patients were followed for returns at 7, 15, 30 and 60 days after baseline. At baseline, all patients were examined and assessed Research Diagnostic Criteria/Temporomandibular Disorder (RDC/TMD form). In addition, the patients were referred for specific treatment according to the group to which belonged. In each session, patients were also surveyed about pain intensity using a Numeric Scale. To analyze the impact of pain on quality of life, Oral Health Impact Profile (OHIP-14) questionnaire was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling Group | Experimental | Behavioral: CounselingPatients allocated to the counseling group (Group I) were informed about possible etiological factors and educated to not overload the temporomandibular joint and masticatory muscles. Techniques to relieve pain and tension were taught to correct postural habits, food and sleep irregularities. The patients received written instructions, as a way of reinforcing the information provided during the initial consultation. In subsequent returns at 7, 15, 30 and 60 days of follow-up, the instructions were given again and patients were asked whether they had detected any habits related to the initiation and maintenance of painful symptoms of TMD, as a way to further highlight the association between the presence of these harmful behaviors and the worsening signs and symptoms of TMD. |
| Splint Group | Active comparator | Device: Interocclusal AppliancesPatients allocated to the splint group (Group II) were treated using interocclusal appliances, according to the following protocol: At baseline, an anterior bite plate (front-plateau) was made from acrylic resin that was placed in the maxillary arch to include the the canine to canine region and promote the disocclusion of the posterior teeth. Patients were instructed to use the device for 24 hours, interspersed with rests of equal length during the first week. After 7 days, the device was removed. A hard splint was then made. At 30 days of follow-up, the splint was fitted and the patients were also asked to use it when they were sleeping. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female individuals
- Positive diagnosis of TMD according to RDC/TMD
- Presence of pain in the orofacial region persisting for at least a week of at least moderate intensity, according to the Numeric Scale of pain
Key exclusion criteria (5 listed)
- TMD treatment for ongoing pain
- Presence of pulpal or periodontal disease
- Orthodontic treatment in progress
- Daily use of analgesics, antidepressants or muscle relaxants
- History of radiotherapy to the head and neck, or any adverse systemic condition that may favor presentation of symptoms involved
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 |
|---|---|---|
| CounselingPatients were informed of their condition and possible etiological factors contributing to the pathology. They were also educated about the postural rest position of the mandible and instructed to perform bilateral chewing and not overload the temporomandibular joint and masticatory muscles. Techniques to relieve pain and tension were taught to correct postural habits, food and sleep irregularities. The patients received written instructions for future reference, as a way of reinforcing the information provided during the initial consultation. | Behavioural | Counseling Group |
| Interocclusal AppliancesPatients were treated using interocclusal appliances | Device | Splint Group |
Primary outcome
Pain as measured by Visual Analogue Scale (VAS)
Time frame: Baseline, 7, 15, 30, 60 days
Visual Analogue Scale
2 secondary outcomes
Quality of life measured by Oral Health Impact Profile (OHIP)
Time frame: Baseline, 7, 15, 30, 60 days
Functional Evaluation measured by TemporoMandibular Index (TMI)
Time frame: Baseline, 7, 15, 30, 60 days
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 5 Mar 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling and Interocclusal Appliances in people with Temporomandibular Disorders, run by Universidade Federal do Rio Grande do Norte.
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 5 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 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Pain as measured by Visual Analogue Scale (VAS) (time frame: Baseline, 7, 15, 30, 60 days). 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 5 Mar 2015.