DiagnosisNCT03162029
Assessment of Mandibular Osseous Changes in Patients With End Stage Renal Failure
An observational study of Diagnosis, run by Cairo University.
Trial summary
This study will be observational study. The goal of this study is to evaluate the quality of mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian patients with chronic renal failure and duration of dialysis using CBCT. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Diagnosis
- What is being tested?
- CBCT imaging
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Nov 2017
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Egyptian participants with End stage renal disease
Who may be able to join
- End stage renal failure (in study group)
- Undergone hemo-dialysis, three times/week (in study group)
- Duration of dialysis (≥1 year) (in study group)
- PTH (140-630)
- Age group (18-40 years)
- Mandible
- Free from any other systemic disease affecting the bone quality
- Egyptian population
Who cannot join
- Early stage of renal disease
- Patients with diabetes, hyperthyroidism, postmenopausal osteoporosis
- Maxilla
- Other language
- Completely Edentulous patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Mandibular Osseous Changes Using Radiomorphometric Indices By Cone Beam Computed Tomography in Patients With End Stage Renal Failure Versus Normal Population
This study will be observational study. The goal of this study is to evaluate the quality of mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian patients with chronic renal failure and duration of dialysis using CBCT.
Read the detailed description
This study will be observational study. The goal of this study is to evaluate the quality of mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian patients with chronic renal failure and duration of dialysis using CBCT. Twenty-six subjects will be included in this study. These will comprise (13) CKD patients "the study group" and (13) healthy patients "the control group" recommended for CBCT imaging for implant placement. The control group will be selected from the Prosthodontic department and Oral Medicine department of Faculty of Oral and Dental Medicine, Cairo University, the study group will be selected from Nephrology and the artificial kidney unit El Kasr -Al Ain Hospital, Cairo University.
- Conditions
- Diagnosis
- Being tested
- CBCT imaging
- Keywords
- CBCT, Bone quality, Renal failure
- Medical subject headings
- Disease, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT imagingOther
CBCT imaging of participants, then take measurement by radiomorphometric indices
| Study group | Role | What they receive |
|---|---|---|
| study group | CBCT imaging of patients with end stage renal failure, undergoing hemo-dialysis Receives: Other: CBCT imaging | |
| control group | CBCT imaging of medically-free participants Receives: Other: CBCT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular cortical index(MCI)
Mandibular cortical index (MCI) is a qualitative index that determines the porosity degree of the lower cortical border of the mandible distal to the mental foramen.The lower border of the mandible can be classified into a three point scale according to MCI, C1: the cortex is sharp on both sides; C2: the cortex had semilunar defects(lacunar resorption) and c3: cortex is clearly porous
Measured: Five months
Secondary outcomes (3)
Mental index(MI)
The quantitative index that used for cortical width measurement at the mental foramen region
Measured: Five months
Panoramic mandibular index(PMI)
Measure the mandibular cortical thickness in relation to the distance between the mental foramen and the inferior border of mandible
Measured: Fivemonths
Anti-gonial index(AI)
A quantitative index measure the cortical width in the region that is anterior to the gonion
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study startAug 2017 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman mamdouh, Cairo University
- Investigators
- Eman M Mohamed, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162029
- Sponsor's protocol ID
- CEBD-CU-2017-05-04
- Status last verified
- Jul 2017
- First submitted
- 17 May 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mandibular Osseous Changes Using Radiomorphometric Indices By Cone Beam Computed Tomography in Patients With End Stage Renal Failure Versus Normal Population
- ClinicalTrials.gov ID
- NCT03162029
- Acronym / sponsor ID
- CEBD-CU-2017-05-04
- Conditions
- Diagnosis
- Keywords
- CBCT, Bone quality, Renal failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 22 May 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.
This study will be observational study. The goal of this study is to evaluate the quality of mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian patients with chronic renal failure and duration of dialysis using CBCT.
Detailed description
This study will be observational study. The goal of this study is to evaluate the quality of mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian patients with chronic renal failure and duration of dialysis using CBCT. Twenty-six subjects will be included in this study. These will comprise (13) CKD patients "the study group" and (13) healthy patients "the control group" recommended for CBCT imaging for implant placement. The control group will be selected from the Prosthodontic department and Oral Medicine department of Faculty of Oral and Dental Medicine, Cairo University, the study group will be selected from Nephrology and the artificial kidney unit El Kasr -Al Ain Hospital, Cairo University.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: CBCT imagingCBCT imaging of patients with end stage renal failure, undergoing hemo-dialysis |
| control group | – | Other: CBCT imagingCBCT imaging of medically-free participants |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Egyptian participants with End stage renal disease
Key inclusion criteria (8 listed)
- End stage renal failure (in study group)
- Undergone hemo-dialysis, three times/week (in study group)
- Duration of dialysis (≥1 year) (in study group)
- PTH (140-630)
- Age group (18-40 years)
Key exclusion criteria (5 listed)
- Early stage of renal disease
- Patients with diabetes, hyperthyroidism, postmenopausal osteoporosis
- Maxilla
- Other language
- Completely Edentulous patients.
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 |
|---|---|---|
| CBCT imagingCBCT imaging of participants, then take measurement by radiomorphometric indices | Other | control group, study group |
Primary outcome
Mandibular cortical index(MCI)
Time frame: Five months
Mandibular cortical index (MCI) is a qualitative index that determines the porosity degree of the lower cortical border of the mandible distal to the mental foramen.The lower border of the mandible can be classified into a three point scale according to MCI, C1: the cortex is sharp on both sides; C2: the cortex had semilunar defects(lacunar resorption) and c3: cortex is clearly porous
3 secondary outcomes
Mental index(MI)
Time frame: Five months
Panoramic mandibular index(PMI)
Time frame: Fivemonths
Anti-gonial index(AI)
Time frame: Five months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: Yes
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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.
Eman M Mohamed, MSc principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosis, run by Cairo University.
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 8 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 19 Jul 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 Eman M Mohamed, MSc (01116226642, eman.mamdouh.87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mandibular cortical index(MCI) (time frame: Five months). 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 19 Jul 2017.