Temporomandibular Joint DisordersNCT01679821
Prevalence of Signs and Symptoms of TMD in Patients Wearing Double Complete Dentures, RPD and in Dentistry Students.
An observational study of Temporomandibular Joint Disorders, run by Universidade Estadual do Oeste do Paraná at 1 site in Brazil.
Trial summary
It was proposed in this study to evaluate the prevalence of TMD signs and symptoms in State University of West of Parana's dental students with natural dentition, in patients with removable partial dentures and double complete dentures. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- A questionnaire and a clinical examination
- How many people
- 210 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2010to Aug 2011
- 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 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Seventy dental students of State University of West of Paraná - UNIOESTE, seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous) and seventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil.
Who may be able to join
- Patients wearing double complete denture, patients wearing just removable partial denture and dentate students.
Who cannot join
- Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual do Oeste do Paraná
Cascavel, Paraná, 85819110
About this study
Official title: Prevalence of Signs and Symptoms of Temporomandibular Disorders (TMD) in Patients Wearing Double Complete Dentures, Removable Partial Dentures and Dentistry Students at State University of West of Paraná - UNIOESTE
It was proposed in this study to evaluate the prevalence of TMD signs and symptoms in State University of West of Parana's dental students with natural dentition, in patients with removable partial dentures and double complete dentures.
Read the detailed description
The Temporomandibular Disorder (TMD) has a high prevalence among the population. Objectives: To evaluate the prevalence of signs and symptoms of TMD. Methodology: 210 randomly selected individuals were evaluated, being divided into three groups with seventy individuals each: Group 1 - dental students with natural dentition. Group 2 - patients with removable partial dentures. And Group 3 - patients with double complete dentures. The questionnaire of the American Academy of Orofacial Pain for triage was employed, then, clinical evaluation was carried out.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- A questionnaire and a clinical examination
- Keywords
- Temporomandibular disorders., Dental prosthesis., Dental students
- 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.
A questionnaire and a clinical examinationOther
Seventy dental students of State University of West of Paraná - UNIOESTE, seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous) and seventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil. Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research. Patients wearing a complete denture in one maxillary and a removable partial denture in another maxillary, and patients wearing just one complete denture were not included in the research.
| Study group | Role | What they receive |
|---|---|---|
| Dental students | Seventy dental students of State University of West of Paraná - UNIOESTE. Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research. A questionnaire and a clinical examination were employed. Receives: Other: A questionnaire and a clinical examination | |
| Removable partial denture | Seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous). Patients wearing a complete denture in one maxillary and a removable partial denture in another maxillary were not included in the research. A questionnaire and a clinical examination were employed. Receives: Other: A questionnaire and a clinical examination | |
| Double complete denture | Seventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil. Patients wearing just one complete denture were not included in the research. A questionnaire and a clinical examination were employed. Receives: Other: A questionnaire and a clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the prevalence of signs and symptoms of temporomandibular disorders in patients with removable partial dentures, complete double dentures and toothed.
Measured: 5 months
Secondary outcomes (1)
questionnaire for selection of orofacial pain and temporomandibular disorders recommended by the American Academy of Orofacial Pain
Measured: 5 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual do Oeste do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maristela Maria Galina Pezzini, Universidade Estadual do Oeste do Paraná
- Investigators
- Maristela Pezzini, Professor, Principal investigator, Universidade Estadual do Oeste do ParanáThaisa Bordin, Student, Principal investigator, Universidade Estadual do Oeste do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679821
- Sponsor's protocol ID
- 538/2010-CEP
- Status last verified
- Sep 2012
- First submitted
- 1 Sep 2012
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Signs and Symptoms of Temporomandibular Disorders (TMD) in Patients Wearing Double Complete Dentures, Removable Partial Dentures and Dentistry Students at State University of West of Paraná - UNIOESTE
- ClinicalTrials.gov ID
- NCT01679821
- Acronym / sponsor ID
- 538/2010-CEP
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Temporomandibular disorders., Dental prosthesis., Dental students
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Universidade Estadual do Oeste do ParanáUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Sep 2012 (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.
It was proposed in this study to evaluate the prevalence of TMD signs and symptoms in State University of West of Parana's dental students with natural dentition, in patients with removable partial dentures and double complete dentures.
Detailed description
The Temporomandibular Disorder (TMD) has a high prevalence among the population. Objectives: To evaluate the prevalence of signs and symptoms of TMD. Methodology: 210 randomly selected individuals were evaluated, being divided into three groups with seventy individuals each: Group 1 - dental students with natural dentition. Group 2 - patients with removable partial dentures. And Group 3 - patients with double complete dentures. The questionnaire of the American Academy of Orofacial Pain for triage was employed, then, clinical evaluation was carried out.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dental students | – | Other: A questionnaire and a clinical examinationSeventy dental students of State University of West of Paraná - UNIOESTE. Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research. A questionnaire and a clinical examination were employed. |
| Removable partial denture | – | Other: A questionnaire and a clinical examinationSeventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous). Patients wearing a complete denture in one maxillary and a removable partial denture in another maxillary were not included in the research. A questionnaire and a clinical examination were employed. |
| Double complete denture | – | Other: A questionnaire and a clinical examinationSeventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil. Patients wearing just one complete denture were not included in the research. A questionnaire and a clinical examination were employed. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Seventy dental students of State University of West of Paraná - UNIOESTE, seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous) and seventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil.
Key inclusion criteria (1 listed)
- Patients wearing double complete denture, patients wearing just removable partial denture and dentate students.
Key exclusion criteria (1 listed)
- Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research.
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 |
|---|---|---|
| A questionnaire and a clinical examinationSeventy dental students of State University of West of Paraná - UNIOESTE, seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous) and seventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil. Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research. Patients wearing a complete denture in one maxillary and a removable partial denture in another maxillary, and patients wearing just one complete denture were not included in the research. | Other | Dental students, Double complete denture, Removable partial denture |
Primary outcome
Assessment of the prevalence of signs and symptoms of temporomandibular disorders in patients with removable partial dentures, complete double dentures and toothed.
Time frame: 5 months
1 secondary outcome
questionnaire for selection of orofacial pain and temporomandibular disorders recommended by the American Academy of Orofacial Pain
Time frame: 5 monts
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 6 Sep 2012.
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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.
Maristela Pezzini, Professor principal investigator
Universidade Estadual do Oeste do Paraná
Thaisa Bordin, Student principal investigator
Universidade Estadual do Oeste do Paraná
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 Temporomandibular Joint Disorders, run by Universidade Estadual do Oeste do Paraná 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 6 Sep 2012. 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.
What does the primary outcome measure?
Assessment of the prevalence of signs and symptoms of temporomandibular disorders in patients with removable partial dentures, complete double dentures and toothed. (time frame: 5 months). 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 6 Sep 2012.