Periodontal DiseasesNCT03102086
The Association Between Nephrolithiasis and Periodontal Status
An observational study of Periodontal Diseases and Nephrolithiasis, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases, Nephrolithiasis
- What is being tested?
- Scaling
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 11 May 2017to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed with kidney stone.
Who may be able to join
- Patients diagnosed with nephrolithiasis
- Over 18 years old
Who cannot join
- Pregnant woman, uncontrolled diabetes (HbA1c > 7.5%), patients who received periodontal treatment in the past 6 months, smokers
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus, Dept. of Periodontology
Haifa, 31096
prof. Eli Machtei, DMD, 9720545503199, machtei@rambam.health.gov.il
About this study
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.
- Conditions
- Periodontal Diseases, Nephrolithiasis
- Being tested
- Scaling
- Medical subject headings
- Periodontal Diseases, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScalingProcedure or surgery
Scaling of dental calculus
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: the analysis will take 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start11 May 2017
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, machtei, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102086
- Sponsor's protocol ID
- 0097-16-RMB
- Status last verified
- Mar 2018
- First submitted
- 30 Mar 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Nephrolithiasis and Periodontal Status
- ClinicalTrials.gov ID
- NCT03102086
- Acronym / sponsor ID
- 0097-16-RMB
- Conditions
- Periodontal Diseases, Nephrolithiasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with kidney stone.
Key inclusion criteria (2 listed)
- Patients diagnosed with nephrolithiasis
- Over 18 years old
Key exclusion criteria (1 listed)
- Pregnant woman, uncontrolled diabetes (HbA1c > 7.5%), patients who received periodontal treatment in the past 6 months, smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScalingScaling of dental calculus | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rambam Health Care Campus, Dept. of Periodontology
Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Nephrolithiasis, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the composition of both specimens (time frame: the analysis will take 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.