BruxismBruxismNCT01778881
Physical Therapy Interventions Relative to Dental Treatment in Individuals With Bruxism
A study testing Massage and stretching exercises, Relaxation and imagination therapies and Dental treatment in people with Bruxism, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Bruxism is a parafunctional habit characterized by grinding and/or clenching of the teeth. It may happen while awake (awake bruxism) or while sleeping (sleep bruxism). In adults, the prevalence is 20% for the awake bruxism and 8% for the sleep bruxism. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Massage and stretching exercises, Relaxation and imagination therapies and Dental treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Dec 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sleep Bruxism identified by the interview, clinical assessment and diagnostic criteria of the International Classification for Sleep Disorders (ICSD) of the American Academy of Sleep Medicine (AASM);
- Awake bruxism identified by the interview, clinical assessment and questionnaire of Pintado;
- Aged between 18 to 60 years;
- A minimum pain intensity score of 3 on the Visual Analogical Scale.
Who cannot join
- More than two missing teeth, except third molars;
- Systemic and/or degenerative diseases;
- Arthrogenic or mixed temporomandibular disorder (TMD) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), axis I;
- Neurological or psychiatric diseases (with the exception of anxiety and depression);
- Using medications that influence sleep or motor behavior;
- Periodontal disorders;
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- Abuse of alcohol and/or illicit drugs;
- Removable dentures, superior and/or inferior;
- Total dentures;
- Direct trauma or past surgery in the orofacial region;
- On physical, speech, dental, or psychological therapy at the time of study entry.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Medicine School of the University Of São Paulo
São Paulo, São Paulo, 01246903
About this study
Official title: Effectiveness of Physical Therapy Interventions, Relative to Dental Treatment in Individuals With Bruxism: a Randomized Clinical Trial
Bruxism is a parafunctional habit characterized by grinding and/or clenching of the teeth. It may happen while awake (awake bruxism) or while sleeping (sleep bruxism). In adults, the prevalence is 20% for the awake bruxism and 8% for the sleep bruxism. Peripheral, central, and psychosocial factors influence the disorder, which may predispose to pain in the masticatory muscles and neck, headache, decreased pain thresholds in the masticatory and cervical muscles, limitation mandibular opening, sleep disorders, stress, anxiety, depression, and overall impairment of oral health. The aim of this study is to compare physical therapy interventions with dental treatment in pain, mandibular opening, sleep quality, anxiety, stress, depression, and oral health in individuals with bruxism.
Read the detailed description
Participants will be randomized into one of four groups: Group 1 (n = 24) intervention will consist of massage and stretching exercises; Group 2 (n = 24) will consist of relaxation and imagination therapies; Group 3 (n = 24) will receive dental treatment and Group 4 (n=24) will consist of massage, exercises, relaxation and imagination. The evaluations will be performed at baseline, immediately after treatment, and at 2-month follow-up. Pain intensity will be assessed using the visual analogical scale, while pain thresholds will be determined using algometry. Mandibular opening will be assessed using digital pachymeter. Sleep quality will be assessed by the Pittsburgh Sleep Quality Index, anxiety by the State-Trait Anxiety Inventory, stress by the Perceived Stress Scale-10, depression by the Beck Depression Inventory, and oral health will be assessed using the Oral Health Impact Profile - 14. Significance level will be determined at the 5% level.
Valid Reasons of updates:
2014 - Changes made according requeriments of plattform of ClinicalTrials.
2015 - In 2014, in my qualification examination at University of São Paulo, the professors suggested my transfer from master degree to direct doctorate and the inclusion of more one intervention group, whereas the other three groups were still in the randomization process. I updated the registration in 2015 with the inclusion of this fourth group. However, as the protocol published in 2014 reports 3 groups (initial idea of the master degree before the transition to the direct doctorate), this fourth group started the treatment (massage, exercises, relaxation and imagination) after the end of treatment of other three groups (Groups:1,2 and 3).
2016- Although I have listed as primary variables: pain (VAS) and mandibular opening in this platform in 2013, and in the protocol published in 2014 (http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15 -8); symptoms like clenching, headaches and sleep difficulties were also assessed by VAS, and no included posteriorly to trial registration. They were evaluated, but not described in this platform. The same happened with intention to treat analysis.
June 20, 2016- Updates for clarifications and suggested by the PRS Team.
Please, any doubts, send me a e-mail! Thank you!
- Conditions
- Bruxism
- Being tested
- Massage and stretching exercises, Relaxation and imagination therapies, Dental treatment, Massage, exercises, relaxation and imagination therapies
- Keywords
- Bruxism, Physical therapy modalities, Massage, Muscle stretching exercises, Relaxation therapy, Imagination
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage and stretching exercisesOther
The routine to be used in this group (stretching, massage, and diaphragmatic breathing).
Relaxation and imagination therapiesOther
The routines to be adopted will focus on progressive muscle relaxation associated to imagination and diaphragmatic breathing.
Dental treatmentOther
Restoring treatment will involve direct reconstruction of the anterior guides (incisive faces of the incisive and canine teeth) with resin.
Massage, exercises, relaxation and imagination therapiesOther
The routine to be used in this group (stretching, massage, diaphragmatic breathing, progressive muscle relaxation and imagination therapies).
| Study group | Role | What they receive |
|---|---|---|
| Massage + Exercise | Experimental | Massage and stretching exercises Receives: Other: Massage and stretching exercises |
| Relaxation +Imagination | Experimental | Relaxation and Imagination therapies Receives: Other: Relaxation and imagination therapies |
| Dental treatment | Experimental | Reconstruction with composite resin Receives: Other: Dental treatment |
| Massage + Exercise + Relaxation + Imagination | Experimental | Massage, stretching exercises, relaxation and imagination Receives: Other: Massage, exercises, relaxation and imagination therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain / Mandibular opening
Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)
Measured: 6 weeks
Secondary outcomes (5)
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: 6 weeks
Anxiety
State-Trait Anxiety Inventory (STAI)
Measured: 6 weeks
Stress
Perceived Stress Scale (PSS)
Measured: 6 weeks
Depression
Beck Depression Inventory (BDI)
Measured: 6 weeks
Oral Health Quality
Oral Health Impact Profile (OHIP-14)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amélia P Marques, PhD, Study director, University of Sao PauloCinthia SM Amorim, MSc, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778881
- Sponsor's protocol ID
- cinthiamiotto
- Acronym
- Bruxism
- Status last verified
- Jun 2016
- First submitted
- 24 Jan 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Santos Miotto Amorim C, Firsoff EF, Vieira GF, Costa JR, Marques AP. Effectiveness of two physical therapy interventions, relative to dental treatment in individuals with bruxism: study protocol of a randomized clinical trial. Trials. 2014 Jan 7;15:8. doi: 10.1186/1745-6215-15-8.
PubMed 24398115
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Therapy Interventions, Relative to Dental Treatment in Individuals With Bruxism: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01778881
- Acronym / sponsor ID
- Bruxism / cinthiamiotto
- Conditions
- Bruxism
- Keywords
- Bruxism, Physical therapy modalities, Massage, Muscle stretching exercises, Relaxation therapy, Imagination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Jan 2013 (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.
Bruxism is a parafunctional habit characterized by grinding and/or clenching of the teeth. It may happen while awake (awake bruxism) or while sleeping (sleep bruxism). In adults, the prevalence is 20% for the awake bruxism and 8% for the sleep bruxism. Peripheral, central, and psychosocial factors influence the disorder, which may predispose to pain in the masticatory muscles and neck, headache, decreased pain thresholds in the masticatory and cervical muscles, limitation mandibular opening, sleep disorders, stress, anxiety, depression, and overall impairment of oral health. The aim of this study is to compare physical therapy interventions with dental treatment in pain, mandibular opening, sleep quality, anxiety, stress, depression, and oral health in individuals with bruxism.
Detailed description
Participants will be randomized into one of four groups: Group 1 (n = 24) intervention will consist of massage and stretching exercises; Group 2 (n = 24) will consist of relaxation and imagination therapies; Group 3 (n = 24) will receive dental treatment and Group 4 (n=24) will consist of massage, exercises, relaxation and imagination. The evaluations will be performed at baseline, immediately after treatment, and at 2-month follow-up. Pain intensity will be assessed using the visual analogical scale, while pain thresholds will be determined using algometry. Mandibular opening will be assessed using digital pachymeter. Sleep quality will be assessed by the Pittsburgh Sleep Quality Index, anxiety by the State-Trait Anxiety Inventory, stress by the Perceived Stress Scale-10, depression by the Beck Depression Inventory, and oral health will be assessed using the Oral Health Impact Profile - 14. Significance level will be determined at the 5% level.
Valid Reasons of updates:
2014 - Changes made according requeriments of plattform of ClinicalTrials.
2015 - In 2014, in my qualification examination at University of São Paulo, the professors suggested my transfer from master degree to direct doctorate and the inclusion of more one intervention group, whereas the other three groups were still in the randomization process. I updated the registration in 2015 with the inclusion of this fourth group. However, as the protocol published in 2014 reports 3 groups (initial idea of the master degree before the transition to the direct doctorate), this fourth group started the treatment (massage, exercises, relaxation and imagination) after the end of treatment of other three groups (Groups:1,2 and 3).
2016- Although I have listed as primary variables: pain (VAS) and mandibular opening in this platform in 2013, and in the protocol published in 2014 (http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15 -8); symptoms like clenching, headaches and sleep difficulties were also assessed by VAS, and no included posteriorly to trial registration. They were evaluated, but not described in this platform. The same happened with intention to treat analysis.
June 20, 2016- Updates for clarifications and suggested by the PRS Team.
Please, any doubts, send me a e-mail! Thank you!
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Massage + Exercise | Experimental | Other: Massage and stretching exercisesMassage and stretching exercises |
| Relaxation +Imagination | Experimental | Other: Relaxation and imagination therapiesRelaxation and Imagination therapies |
| Dental treatment | Experimental | Other: Dental treatmentReconstruction with composite resin |
| Massage + Exercise + Relaxation + Imagination | Experimental | Other: Massage, exercises, relaxation and imagination therapiesMassage, stretching exercises, relaxation and imagination |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sleep Bruxism identified by the interview, clinical assessment and diagnostic criteria of the International Classification for Sleep Disorders (ICSD) of the American Academy of Sleep Medicine (AASM);
- Awake bruxism identified by the interview, clinical assessment and questionnaire of Pintado;
- Aged between 18 to 60 years;
- A minimum pain intensity score of 3 on the Visual Analogical Scale.
Key exclusion criteria (11 listed)
- More than two missing teeth, except third molars;
- Systemic and/or degenerative diseases;
- Arthrogenic or mixed temporomandibular disorder (TMD) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), axis I;
- Neurological or psychiatric diseases (with the exception of anxiety and depression);
- Using medications that influence sleep or motor behavior;
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 |
|---|---|---|
| Massage and stretching exercisesThe routine to be used in this group (stretching, massage, and diaphragmatic breathing). | Other | Massage + Exercise |
| Relaxation and imagination therapiesThe routines to be adopted will focus on progressive muscle relaxation associated to imagination and diaphragmatic breathing. | Other | Relaxation +Imagination |
| Dental treatmentRestoring treatment will involve direct reconstruction of the anterior guides (incisive faces of the incisive and canine teeth) with resin. | Other | Dental treatment |
| Massage, exercises, relaxation and imagination therapiesThe routine to be used in this group (stretching, massage, diaphragmatic breathing, progressive muscle relaxation and imagination therapies). | Other | Massage + Exercise + Relaxation + Imagination |
Primary outcome
Pain / Mandibular opening
Time frame: 6 weeks
Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)
5 secondary outcomes
Sleep Quality
Time frame: 6 weeks
Anxiety
Time frame: 6 weeks
Stress
Time frame: 6 weeks
Depression
Time frame: 6 weeks
Oral Health Quality
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 24398115Santos Miotto Amorim C, Firsoff EF, Vieira GF, Costa JR, Marques AP. Effectiveness of two physical therapy interventions, relative to dental treatment in individuals with bruxism: study protocol of a randomized clinical trial. Trials. 2014 Jan 7;15:8. doi: 10.1186/1745-6215-15-8.
- Individual participant dataSharing planned: No
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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.
Amélia P Marques, PhD study director
University of Sao Paulo
Cinthia SM Amorim, MSc principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage and stretching exercises, Relaxation and imagination therapies and Dental treatment in people with Bruxism, run by University of Sao Paulo General Hospital 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 26 Oct 2016. 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?
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?
Pain / Mandibular opening (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01778881, which also lists 1 linked publication.
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 26 Oct 2016.