NCT03102086

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 11, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 16, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

March 30, 2017

Last Update Submit

May 15, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • the composition of both specimens

    The X-ray diffraction of both kidney stone and dental calculus will result in the composition of the two, and comparison will be done

    the analysis will take 9 months

Interventions

ScalingPROCEDURE

Scaling of dental calculus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with kidney stone.

You may qualify if:

  • Patients diagnosed with nephrolithiasis
  • Over 18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus, Dept. of Periodontology

Haifa, 31096, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

kidney stones and dental calculus

MeSH Terms

Conditions

Periodontal DiseasesNephrolithiasis

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 5, 2017

Study Start

May 11, 2017

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

May 16, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations