Patients Undergoing HemodialysisEarly Phase 1NCT04448093
Relationship Between Quality of Life, Self-image and Oral Health in Patients Undergoing Hemodialysis
A Early Phase 1 study testing dental treatment in people with Patients Undergoing Hemodialysis, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Patients Undergoing Hemodialysis
- What is being tested?
- dental treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2014to 20 Dec 2019
- Phase
- Early Phase 1
- 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 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years
- submitted to hemodialysis
- agreed to participate voluntarily by invitation and sign an informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Periodontics Clinic, Department of Dentistry
Diamantina, Minas Gerais, 39100000
About this study
Official title: Relationship Between Quality of Life, Self-image and Oral Health in Patients Undergoing Hemodialysis: A Comparative Study.
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 .
Read the 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
- Being tested
- dental treatment
- Keywords
- Quality of life, Dentistry, Renal dialysis, Epidemiology, Self-image
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Treated group (53) that answered quality of life questionnaires before, after and with 45 days of treatment. Receives: Procedure: dental treatment |
| Group control | No intervention | Untreated group (68) that answered quality of life questionnaires before, after and with 45 days of treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental treatment
Comparison of quality of life and self-esteem results of patients who underwent dental treatment with others who did not.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Mar 2014
- Primary completion29 Aug 2015
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing HemodialysisStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group and control group.
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Flecha, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448093
- Sponsor's protocol ID
- Hemodialysis
- Status last verified
- Jun 2020
- First submitted
- 9 Mar 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Quality of Life, Self-image and Oral Health in Patients Undergoing Hemodialysis: A Comparative Study.
- ClinicalTrials.gov ID
- NCT04448093
- Acronym / sponsor ID
- Hemodialysis
- Conditions
- Patients Undergoing Hemodialysis
- Keywords
- Quality of life, Dentistry, Renal dialysis, Epidemiology, Self-image
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 29 Aug 2015 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 25 Jun 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Procedure: dental treatmentTreated group (53) that answered quality of life questionnaires before, after and with 45 days of treatment. |
| Group control | No intervention | –Untreated group (68) that answered quality of life questionnaires before, after and with 45 days of treatment. |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 18 years
- submitted to hemodialysis
- agreed to participate voluntarily by invitation and sign an informed consent form
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| dental treatmentDental 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. | Procedure or surgery | Treatment group |
Primary outcome
Dental treatment
Time frame: 6 years
Comparison of quality of life and self-esteem results of patients who underwent dental treatment with others who did not.
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 25 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing dental treatment in people with Patients Undergoing Hemodialysis, run by Federal University of São Paulo 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 3 inclusion and 6 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 25 Jun 2020. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dental treatment (time frame: 6 years). 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 25 Jun 2020.