Assessment of Mandibular Osseous Changes in Patients With End Stage Renal Failure

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.

Study Overview

• Status: Unknown
• Conditions: Diagnosis
• Intervention / Treatment: Other: CBCT imaging

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 Type: Observational
• Enrollment (Anticipated): 26

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Egyptian participants with End stage renal disease

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Early stage of renal disease
• Patients with diabetes, hyperthyroidism, postmenopausal osteoporosis
• Maxilla
• Other language
• Completely Edentulous patients.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; CBCT imaging of patients with end stage renal failure, undergoing hemo-dialysis	Other: CBCT imaging; CBCT imaging of participants, then take measurement by radiomorphometric indices
control group; CBCT imaging of medically-free participants	Other: CBCT imaging; CBCT imaging of participants, then take measurement by radiomorphometric indices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Five months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental index(MI)	The quantitative index that used for cortical width measurement at the mental foramen region	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	Fivemonths
Anti-gonial index(AI)	A quantitative index measure the cortical width in the region that is anterior to the gonion	Five months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Eman M Mohamed, MSc, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: CBCT; Renal failure; Bone quality
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: CEBD-CU-2017-05-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No