Oral DiseaseNCT03074188
Prevalence of Oral Findings in Chronic Kidney Disease
An observational study of Oral Disease and Chronic Kidney Diseases, run by Alaa Mostafa Hassan Elnaggar.
Trial summary
There are severe deficiency of database concerning the oral health status in both pre-dialysis and end stage renal disease in Egyptian population. Our aim in the present study is to assess the oral health of the chronic kidney disease patients to increase their awareness and minimize all the possible risk factors, to… 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 May 2018
- How long will I take part?
- 1 Day
- 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.
About this study
Official title: Prevalence of Oral Findings in Adult Patients With Chronic Kidney Disease "Cross Sectional
There are severe deficiency of database concerning the oral health status in both pre-dialysis and end stage renal disease in Egyptian population. Our aim in the present study is to assess the oral health of the chronic kidney disease patients to increase their awareness and minimize all the possible risk factors, to achieve a proper management for all oral problems.
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.
Sample size estimation:
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 manifestation, pre-dialysis stage 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 patients | 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 lesion
Clinical examination according to WHO guidelines
Measured: 10 minutes
Secondary outcomes (2)
.Periodontal condition
Basic periodontal examination
Measured: 10 minutes
Hepatitis C Virus at dialysis stage
HCV antibodies in patient blood
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Primary completion30 May 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)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Alaa Mostafa Hassan Elnaggar
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Alaa Mostafa Hassan Elnaggar, Cairo University
- Investigators
- Mariam fakhr, Study chair, the Nephrology units at the Kasr Al-Ainy Cairo university hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074188
- Sponsor's protocol ID
- kidney _oral findings
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2017
- Last updated
- 8 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 8 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
- ClinicalTrials.gov ID
- NCT03074188
- Acronym / sponsor ID
- kidney _oral findings
- Conditions
- Oral Disease, Chronic Kidney Diseases
- Keywords
- oral findings or oral manifestation, pre-dialysis stage or end stage renal disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Alaa Mostafa Hassan ElnaggarUniversity, hospital or other
- Collaborators
- Cairo University
- Primary completion
- 30 May 2018 (estimated)
- First posted
- 8 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.
There are severe deficiency of database concerning the oral health status in both pre-dialysis and end stage renal disease in Egyptian population. Our aim in the present study is to assess the oral health of the chronic kidney disease patients to increase their awareness and minimize all the possible risk factors, to achieve a proper management for all oral problems.
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.
Sample size estimation:
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
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-dialysis patients | – | – |
| 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 lesion
Time frame: 10 minutes
Clinical examination according to WHO guidelines
2 secondary outcomes
.Periodontal condition
Time frame: 10 minutes
Hepatitis C Virus at dialysis stage
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Results publication: 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
Related trials for Oral Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial
Oral and Maxillofacial Conditions
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
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.
Mariam fakhr study chair
the Nephrology units at the Kasr Al-Ainy Cairo university hospital.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Disease and Chronic Kidney Diseases, run by Alaa Mostafa Hassan Elnaggar.
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 8 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 alaa elnaggar, BDS (01007802767 ext. 01204993009, alaa_hassan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral mucosal lesion (time frame: 10 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 NCT03074188, 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 8 Mar 2017.