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

NCT03162029 | Unknown

• 1 other identifier: CEBD-CU-2017-05-04
• Study Type: observational
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diagnosis

Keywords

CBCT; Bone quality; Renal failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mental index(MI)

  Five months

• Panoramic mandibular index(PMI)

  Fivemonths

• Anti-gonial index(AI)

  Five months

Study Arms (2)

study group

CBCT imaging of patients with end stage renal failure, undergoing hemo-dialysis

Other: CBCT imaging

control group

CBCT imaging of medically-free participants

Other: CBCT imaging

Interventions

CBCT imaging OTHER

CBCT imaging of participants, then take measurement by radiomorphometric indices

control group; study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Egyptian participants with End stage renal disease

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Disease; Renal Insufficiency

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Eman M Mohamed, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman M Mohamed, MSc

CONTACT

01116226642; eman.mamdouh.87@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 22, 2017
• Study Start: August 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share