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The Association Between Nephrolithiasis and Periodontal Status

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102086
Recruitment Status : Unknown
Verified March 2018 by machtei, Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : April 5, 2017
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
machtei, Rambam Health Care Campus

Brief Summary:

Dental calculus is a calcified deposits firmly attached to teeth and implants surfaces. Dental calculus is strongly associated with periodontitis and considered to have indirect role in the pathogenesis of periodontal diseases. Dental calculus composed primarily of calcium phosphate mineral salts originated in the saliva covered by unmineralized bacterial layer. Composition of calculus varies from person to person and influenced by numerous variables such as: age, gender systemic disease and ethnic background.

Nephrolithiasis (kidney stones) are composed of insoluble salts of constituents of the forming urine. The most two frequent stone types are: Calcium oxalate (with a frequency of 15% -35%) and Calcium phosphate (5% -20%). The prevalence of kidney stones varies with race, sex, and geographic location. In the United States for men, kidney stone rates vary between 4%-9%, and for women, kidney stone rates range between 2%-4%.

Previous studies dealt with the connection between sialolithiasis and nephrolithiasis were inconclusive. To the authors' best knowledge no studies were done to examine the associations between nephrolithiasis and dental calculus. Thus, the aim of this study is to compare the mineral composition of both dental calculus and nephrolithiasis and determine whether nephrolithiasis composition may be linked to the periodontal status.


Condition or disease Intervention/treatment
Periodontal Diseases Nephrolithiasis Procedure: Scaling

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Association Between Nephrolithiasis and Periodontal Status
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones


Intervention Details:
  • Procedure: Scaling
    Scaling of dental calculus


Primary Outcome Measures :
  1. the composition of both specimens [ Time Frame: the analysis will take 9 months ]
    The X-ray diffraction of both kidney stone and dental calculus will result in the composition of the two, and comparison will be done


Biospecimen Retention:   Samples Without DNA
kidney stones and dental calculus


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients diagnosed with kidney stone.
Criteria

Inclusion Criteria:

  • Patients diagnosed with nephrolithiasis
  • Over 18 years old

Exclusion Criteria:

  • Pregnant woman, uncontrolled diabetes (HbA1c > 7.5%), patients who received periodontal treatment in the past 6 months, smokers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102086


Locations
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Israel
Rambam Health Care Campus, Dept. of Periodontology Recruiting
Haifa, Israel, 31096
Contact: prof. Eli Machtei, DMD    9720545503199    machtei@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
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Responsible Party: machtei, Prof, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03102086    
Other Study ID Numbers: 0097-16-RMB
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontal Diseases
Nephrolithiasis
Kidney Calculi
Mouth Diseases
Stomatognathic Diseases
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical