Chronic Kidney DiseasesNCT06487689
Oral Manifestations in Chronic Kidney Disease.
An observational study of Chronic Kidney Diseases and Hemodyalysis, run by José López Lopez at 1 site in Spain.
Trial summary
The goal of this observational study is to investigate oral manifestations in patients with Chronic Kidney Disease (CKD) for early detection, that alterations play an important point for dental guide during the progression and type of treatment of CKD . Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Hemodyalysis, Pre-dyalisis
- How many people
- 449 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2024to 25 May 2024
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population with Chronic Kidney Disease, in pre-dialysis, hemodialysis, peritoneal dialysis
Who may be able to join
- Age ≥ 18 years and ≤ 80 years;
- No change of medication in the last 3 months;
- History of CKD comported by data laboratory (GRF<60 ml/min/1.73m²).
Who cannot join
- Age ≤ 18 years and ≥ 80 years;
- Patients undergoing orthodontic therapy;
- Patients taking drugs;
- Patients changes the medication or introduced a new medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Manifestations in Chronic Kidney Disease: Clinical Trial
The goal of this observational study is to investigate oral manifestations in patients with Chronic Kidney Disease (CKD) for early detection, that alterations play an important point for dental guide during the progression and type of treatment of CKD .
An oral exam was performed for detection oral manifestations, age, smoking, alcoholic and oral hygiene habits were collected.
The study has 3 groups under study: hemodialysis (HD), peritoneal dialysis (PD) and pre-dialysis (P-D)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodyalisis | Not described | |
| Peritoneal dyalisis | Not described | |
| Pre-dyalisis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal status
periodontrogram (probe CP12)
Measured: 2 years
Secondary outcomes (7)
Sex
qualitative variable: Male/Female
Measured: 2 years
Age
nominal variable: years
Measured: 2 years
Type of CKD
qualitative variable: pre-dialysis, peritoneal dialysis, hemodialysis
Measured: 2 years
time with CKD
nominal variable: years
Measured: 2 years
time of treatment
nominal variable: years
Measured: 2 years
smoking and alcohol habits
qualitative variable: YES/NO
Measured: 2 years
oral lesions
qualitative variable: uremic odor, xerostomia, taste disorder, petechiae, tongue coating
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start10 Jan 2024
- Primary completion15 Mar 2024
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- José López Lopez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José López Lopez, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487689
- Sponsor's protocol ID
- Renal-Oral
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Manifestations in Chronic Kidney Disease: Clinical Trial
- ClinicalTrials.gov ID
- NCT06487689
- Acronym / sponsor ID
- Renal-Oral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- José López LopezUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 5 Jul 2024 (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 goal of this observational study is to investigate oral manifestations in patients with Chronic Kidney Disease (CKD) for early detection, that alterations play an important point for dental guide during the progression and type of treatment of CKD .
An oral exam was performed for detection oral manifestations, age, smoking, alcoholic and oral hygiene habits were collected.
The study has 3 groups under study: hemodialysis (HD), peritoneal dialysis (PD) and pre-dialysis (P-D)
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemodyalisis | – | – |
| Peritoneal dyalisis | – | – |
| Pre-dyalisis | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population with Chronic Kidney Disease, in pre-dialysis, hemodialysis, peritoneal dialysis
Key inclusion criteria (3 listed)
- Age ≥ 18 years and ≤ 80 years;
- No change of medication in the last 3 months;
- History of CKD comported by data laboratory (GRF<60 ml/min/1.73m²).
Key exclusion criteria (4 listed)
- Age ≤ 18 years and ≥ 80 years;
- Patients undergoing orthodontic therapy;
- Patients taking drugs;
- Patients changes the medication or introduced a new medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Periodontal status
Time frame: 2 years
periodontrogram (probe CP12)
7 secondary outcomes
Sex
Time frame: 2 years
Age
Time frame: 2 years
Type of CKD
Time frame: 2 years
time with CKD
Time frame: 2 years
time of treatment
Time frame: 2 years
smoking and alcohol habits
Time frame: 2 years
oral lesions
Time frame: 2 years
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 5 Jul 2024.
- Individual participant dataSharing planned: No
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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?
An observational study of Chronic Kidney Diseases and Hemodyalysis, run by José López Lopez at 1 site in Spain.
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 4 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 5 Jul 2024. 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 Spain. 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?
Periodontal status (time frame: 2 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 5 Jul 2024.