Relationship Between Quality of Life, Self-image and Oral Health in Patients Undergoing Hemodialysis
1 other identifier
interventional
121
1 country
1
Brief Summary
The objective of this work will be to conduct a controlled clinical trial to assess whether the dental treatment of adequacy of the oral environment is capable of generating improvement in the quality of life and self-esteem, comparing the results of patients on hemodialysis who received treatment with others who did not receive treatment .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2014
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2019
CompletedFirst Submitted
Initial submission to the registry
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedJune 25, 2020
June 1, 2020
1.5 years
March 9, 2020
June 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dental treatment
Comparison of quality of life and self-esteem results of patients who underwent dental treatment with others who did not.
6 years
Study Arms (2)
Treatment group
EXPERIMENTALTreated group (53) that answered quality of life questionnaires before, after and with 45 days of treatment.
Group control
NO INTERVENTIONUntreated group (68) that answered quality of life questionnaires before, after and with 45 days of treatment.
Interventions
Dental treatment of adequacy of oral environment and assessment of quality of life and self-esteem through questionnaires comparing a group that received treatment with another that did not.
Eligibility Criteria
You may qualify if:
- patients over 18 years
- submitted to hemodialysis
- agreed to participate voluntarily by invitation and sign an informed consent form
You may not qualify if:
- severe anemia
- uncontrolled systolic and diastolic blood pressure or greater than 180/110 mmHg
- unstable angina, complex ventricular arrhythmias, severe metabolic disease
- acute myocardial infarction less than a month
- acute conditions, aortic aneurysm, severe aortic stenosis or respiratory impairment
- neurological and / or musculoskeletal that contraindicate treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Periodontics Clinic, Department of Dentistry
Diamantina, Minas Gerais, 39100000, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 9, 2020
First Posted
June 25, 2020
Study Start
March 1, 2014
Primary Completion
August 29, 2015
Study Completion
December 20, 2019
Last Updated
June 25, 2020
Record last verified: 2020-06