Relationship Between Quality of Life, Self-image and Oral Health in Patients Undergoing Hemodialysis

NCT ID: NCT04448093

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-01
• Study Completion Date: 2019-12-20

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 .

Detailed Description

After selecting the sample, patients will undergo an oral examination performed by a dental surgeon, in which they will be evaluated for the presence of lesions in the oral mucosa, periodontal conditions through simplified periodontal record - PSR, oral hygiene index, caries and lack of teeth - DMFT, if they need treatment and the situation of the prosthesis, if they use them, the data being recorded in a specific medical record. Subsequently, intervention will be performed in the group that received the treatment (intervention group). The treatment will consist of the adequacy of the oral environment in patients with teeth and evaluation of the mucosa and prostheses for edentulous patients.

The service will take place at the UFVJM Surgery and Periodontics Clinic, on previously scheduled days and times. About 5 to 10 days before treatment, patients answered questionnaires about socioeconomic characterization, self-esteem and quality of life. The therapeutic protocol followed during the service will be the one proposed by Quirynen (1995) [22], in which the debridement of the entire mouth is recommended in a single 45-minute session. After removing the supra and subgingival biofilm, the patient will be instructed to use mouthwashes with 15 ml of 0.12% chlorhexidine gluconate, for one minute, twice a day, thirty minutes after brushing, for seven days. In this phase, emergency extractions, restoration of restorations and cavity closure with glass ionomer cement and resins in the anterior teeth will also be performed, in order to adapt the oral environment in minimal interventions, considering the patient's systemic state.

All patients who have at least 1 tooth, healthy or not, will be considered dentate. Toothless patients will receive guidance on oral hygiene and prostheses, if used, and will also use mouthwash with 0.12% chlorhexidine gluconate for the same period. Group participants who were not submitted to the intervention (control group), received the same initial assessment and answered the same questionnaires, but will not be treated at that time. After 45 days from the end of the dental treatment, everyone will be reassessed, went through oral hygiene instructions again and answered the questionnaires, the questions being directed to the patient's perception in the last 45 days after treatment.

Conditions

Patients Undergoing Hemodialysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Treated group (53) that answered quality of life questionnaires before, after and with 45 days of treatment.

Group Type: EXPERIMENTAL

dental treatment

Intervention Type: PROCEDURE

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.

Group control

Untreated group (68) that answered quality of life questionnaires before, after and with 45 days of treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

dental treatment

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients over 18 years
• submitted to hemodialysis
• agreed to participate voluntarily by invitation and sign an informed consent form

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Olga Flecha

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Periodontics Clinic, Department of Dentistry

Diamantina, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

Hemodialysis

Identifier Type: -

Identifier Source: org_study_id