Oral DiseaseNCT03082365
Oral Findings in Chronic Kidney Disease
An observational study of Oral Disease and Chronic Kidney Diseases, run by Maryam Ahmed Essam Abdel Salam.
Trial summary
The patients with chronic kidney disease suffer from many oral problems affecting the quality of life. The aim of our study is to assess their oral health to provide the proper management and increase their awareness Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Disease, Chronic Kidney Diseases
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Start not givento 30 Mar 2018
- 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 years and older
- All sexes
- Adult, Older adult
Study population: A convenience sample of adult patients diagnosed with chronic kidney disease attending at the Nephrology units at El Kasr Al-Ainy Cairo University Hospital will be enrolled in the study in a consecutive order
Who may be able to join
- Adult patients >18 years old with a diagnosis of non-dialysis chronic kidney disease at stage 2, 3 and 4.
- Adult patients >18 years old with a diagnosis of end stage renal disease "stage 5".
- Recorded data of Glomerular Filtration Rate for every patient.
- Recorded data for dialysis patients (HCV, platelets count, creatinine, blood urea nitrogen, urea level and partial thromboplastin time).
Who cannot join
- Adult patients <18 years.
- End stage renal disease undergoing peritoneal dialysis.
- Patients not physically able to participate in oral examination.
- Patients with kidney transplantation.
- Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure, accidents, trauma, snake poisoning
Trial locations and contacts
No sites are listed yet.
gihane madkour contact
About this study
Official title: Prevalence of Oral Findings in Adult Patients With Chronic Kidney Disease '' Cross Sectional 2 "
The patients with chronic kidney disease suffer from many oral problems affecting the quality of life. The aim of our study is to assess their oral health to provide the proper management and increase their awareness
Read the detailed description
The study will be held in the Nephrology units at the Kasr Al-Ainy Cairo university hospital.
The data collected through the questionnaire will be obtained through an interview between the investigator and the patient. Clinical examination will be performed for both oral (soft tissue) and dental (hard) tissue. For patients undergoing dialysis, examination will be performed before dialysis therapy Selection bias: will be minimized by enrolling the participants in the study in a consecutive order of the entering the clinic.
Non-respondent bias: will be minimized by explaining to the participants the aim of the study and their importance and role in the study.
Incomplete records: will be excluded from statistical analysis with reporting the cause of not completing the record.
Using a precision of 5, a design effect set at 1 with 90% CI (confidence interval), a total sample size of 250 pre-dialysis patients and 200 end stage renal disease patients will be sufficient. The sample size was calculated by Epi info software.The sample will be divided between two researchers; each researcher will have 50% of the whole sample to collect
- Conditions
- Oral Disease, Chronic Kidney Diseases
- Keywords
- oral findings or oral manifestations, pre-dialysis or end stage renal disease
- Medical subject headings
- Mouth Diseases, Renal Insufficiency, Chronic, Oral Manifestations, Kidney Failure, 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 |
|---|---|---|
| pre-dialysis | Not described | |
| end stage renal disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral mucosal lesions
Clinical examination according to WHO guidelines
Measured: 15 minutes
Secondary outcomes (2)
Periodontal condition
Basic periodontal examination
Measured: 10 minutes
Hepatitis C Virus at dialysis stage
HCV antibodies in patient blood
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Primary completion30 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral DiseaseStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maryam Ahmed Essam Abdel Salam
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Maryam Ahmed Essam Abdel Salam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082365
- Sponsor's protocol ID
- renal_oral findings
- Status last verified
- Mar 2017
- First submitted
- 12 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gautam NR, Gautam NS, Rao TH, Koganti R, Agarwal R, Alamanda M. Effect of end-stage renal disease on oral health in patients undergoing renal dialysis: A cross-sectional study. J Int Soc Prev Community Dent. 2014 Sep;4(3):164-9. doi: 10.4103/2231-0762.142006.
PubMed 25374834
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Oral Findings in Adult Patients With Chronic Kidney Disease '' Cross Sectional 2 "
- ClinicalTrials.gov ID
- NCT03082365
- Acronym / sponsor ID
- renal_oral findings
- Conditions
- Oral Disease, Chronic Kidney Diseases
- Keywords
- oral findings or oral manifestations, pre-dialysis or end stage renal disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Maryam Ahmed Essam Abdel SalamUniversity, hospital or other
- Collaborators
- Cairo University
- Primary completion
- 30 Mar 2018 (estimated)
- First posted
- 17 Mar 2017 (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 patients with chronic kidney disease suffer from many oral problems affecting the quality of life. The aim of our study is to assess their oral health to provide the proper management and increase their awareness
Detailed description
The study will be held in the Nephrology units at the Kasr Al-Ainy Cairo university hospital.
The data collected through the questionnaire will be obtained through an interview between the investigator and the patient. Clinical examination will be performed for both oral (soft tissue) and dental (hard) tissue. For patients undergoing dialysis, examination will be performed before dialysis therapy Selection bias: will be minimized by enrolling the participants in the study in a consecutive order of the entering the clinic.
Non-respondent bias: will be minimized by explaining to the participants the aim of the study and their importance and role in the study.
Incomplete records: will be excluded from statistical analysis with reporting the cause of not completing the record.
Using a precision of 5, a design effect set at 1 with 90% CI (confidence interval), a total sample size of 250 pre-dialysis patients and 200 end stage renal disease patients will be sufficient. The sample size was calculated by Epi info software.The sample will be divided between two researchers; each researcher will have 50% of the whole sample to collect
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-dialysis | – | – |
| end stage renal disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of adult patients diagnosed with chronic kidney disease attending at the Nephrology units at El Kasr Al-Ainy Cairo University Hospital will be enrolled in the study in a consecutive order
Key inclusion criteria (4 listed)
- Adult patients >18 years old with a diagnosis of non-dialysis chronic kidney disease at stage 2, 3 and 4.
- Adult patients >18 years old with a diagnosis of end stage renal disease "stage 5".
- Recorded data of Glomerular Filtration Rate for every patient.
- Recorded data for dialysis patients (HCV, platelets count, creatinine, blood urea nitrogen, urea level and partial thromboplastin time).
Key exclusion criteria (5 listed)
- Adult patients <18 years.
- End stage renal disease undergoing peritoneal dialysis.
- Patients not physically able to participate in oral examination.
- Patients with kidney transplantation.
- Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure, accidents, trauma, snake poisoning
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
Oral mucosal lesions
Time frame: 15 minutes
Clinical examination according to WHO guidelines
2 secondary outcomes
Periodontal condition
Time frame: 10 minutes
Hepatitis C Virus at dialysis stage
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Background: PubMed 25374834Gautam NR, Gautam NS, Rao TH, Koganti R, Agarwal R, Alamanda M. Effect of end-stage renal disease on oral health in patients undergoing renal dialysis: A cross-sectional study. J Int Soc Prev Community Dent. 2014 Sep;4(3):164-9. doi: 10.4103/2231-0762.142006.
- Individual participant dataSharing planned: Undecided
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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.
gihane madkour contact
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Disease and Chronic Kidney Diseases, run by Maryam Ahmed Essam Abdel Salam.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact maryam abdelsalam, BDS (01100686304, maryamessam20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral mucosal lesions (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082365, which also lists 1 linked publication.
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 17 Mar 2017.