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

• Conditions: Diagnosis
• Interventions: Other: CBCT imaging

• Registration Number: NCT03162029
• Lead Sponsor: Cairo University

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-22
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19
• Study Start: 2017-08
• Primary Completion: 2017-10
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	CBCT imaging	CBCT imaging of patients with end stage renal failure, undergoing hemo-dialysis
control group	CBCT imaging	CBCT imaging of medically-free participants

Primary Outcome Measures

Name	Time	Method
Mandibular cortical index(MCI)	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

Secondary Outcome Measures

Name	Time	Method
Mental index(MI)	Five months	The quantitative index that used for cortical width measurement at the mental foramen region
Panoramic mandibular index(PMI)	Fivemonths	Measure the mandibular cortical thickness in relation to the distance between the mental foramen and the inferior border of mandible
Anti-gonial index(AI)	Five months	A quantitative index measure the cortical width in the region that is anterior to the gonion