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

Diagnosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03162029
• Other study ID #: CEBD-CU-2017-05-04
• Status: Not yet recruiting
• Phase: N/A
• First received: May 17, 2017
• Last updated: July 18, 2017
• Start date: August 2017
• Est. completion date: November 2017

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: Eman M Mohamed, MSc
• Phone: 01116226642
• Email: eman.mamdouh.87[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diagnosis
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• CBCT imaging
CBCT imaging of participants, then take measurement by radiomorphometric indices

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mental index(MI)	The quantitative index that used for cortical width measurement at the mental foramen region	Five months
Secondary	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
Secondary	Anti-gonial index(AI)	A quantitative index measure the cortical width in the region that is anterior to the gonion	Five months