Prevalence of Signs and Symptoms of TMD in Patients Wearing Double Complete Dentures, RPD and in Dentistry Students.

September 5, 2012 updated by: Maristela Maria Galina Pezzini, Universidade Estadual do Oeste do Paraná

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraná
      • Cascavel, Paraná, Brazil, 85819110
        • Universidade Estadual do Oeste do Paraná

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

- Patients wearing double complete denture, patients wearing just removable partial denture and dentate students.

Exclusion Criteria:

Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: A questionnaire and a clinical examination
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.
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.
Other: A questionnaire and a clinical examination
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.
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.
Other: A questionnaire and a clinical examination
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
questionnaire for selection of orofacial pain and temporomandibular disorders recommended by the American Academy of Orofacial Pain
Time Frame: 5 monts
5 monts

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical examination
Time Frame: 5 months
A clinical examination, which was divided into parts, namely: identification and analysis; part of the Axis I of RDC/TMD - Research Criteria for Temporomandibular Disorders; muscle palpation; and for patients with dentures, the history and clinical evaluation of them
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual do Oeste do Paraná

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maristela Pezzini, Professor, Universidade Estadual do Oeste do Paraná
  • Principal Investigator: Thaisa Bordin, Student, Universidade Estadual do Oeste do Paraná

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 538/2010-CEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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