Alveolar Bone LossNCT03088488
Vitamin D and Periodontitis
An observational study of Alveolar Bone Loss, run by Ordu University.
Trial summary
Vitamin D has become important for periodontal disease due to play a role in autoimmunity, bone mineral metabolism and inflammation. Our aim was to investigate the relation between serum 25-hydroxy vitamin D levels, clinical periodontal parameters and blood serum biomarkers. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- fasting venous blood samples
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 21 Apr 2016
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Sixty patients (35 girls) who were aged between 25-45 years (30.8 (mean) ± 4.9 (standard deviation) and presented to our faculty for periodontal and other dental problems, participated in the study. Subjects were divided in to 2 groups each containing 30 patients: * Group I - periodontal healthy * Group II - untreated chronic periodontitis (radiographic evidence of bone loss and clinical attachment loss in excess of 5 mm in more than six teeth)
Who may be able to join
- never-smokers
- no history of systemic disease
- no patients had been under periodontal therapy and medicine for at least 6 months before the study
- no pregnancy or lactation
- no alcohol or antioxidant vitamin consumption.
Who cannot join
- -
About this study
Official title: Relationship of Bone Metabolism Biomarkers and Serum 25-Hydroxy Vitamin D in Patients With Chronic Periodontitis
Vitamin D has become important for periodontal disease due to play a role in autoimmunity, bone mineral metabolism and inflammation. Our aim was to investigate the relation between serum 25-hydroxy vitamin D levels, clinical periodontal parameters and blood serum biomarkers. The subjects were evaluated in 2 groups as chronic periodontitis (n= 30) and periodontally healthy subjects (n= 30). Periodontal parameters and fasting venous blood samples were taken from the subjects to assess each patient's periodontal status and for biochemical analyses (25-hydroxy vitamin D (25-OH vit D), osteoprotegerin (OPG), receptor activator of nuclear kappa B ligand (RANKL), C-telopeptide (CTx), tumor necrosis factor-α (TNF-α)).
- Conditions
- Alveolar Bone Loss
- Being tested
- fasting venous blood samples
- Keywords
- 25-OH vitamin D, RANKL, Osteoprotogerin, TNF-α
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fasting venous blood samplesDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Periodontally healthy subjects | Not described Receives: Diagnostic Test: fasting venous blood samples | |
| Chronic periodontitis patients | Not described Receives: Diagnostic Test: fasting venous blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical parameters
serum TNF-α
Measured: Baseline
Biochemical parameters
serum CTx
Measured: Baseline
Biochemical parameters
serum RANKL
Measured: Baseline
Biochemical parameters
serum OPG
Measured: Baseline
Biochemical parameters
serum 25-OH vitamin D
Measured: Baseline
Secondary outcomes (4)
Periodontal parameters
The plaque index (PI)
Measured: Baseline
Periodontal parameters
gingival index (GI)
Measured: Baseline
Periodontal parameters
probing depth (PD)
Measured: Baseline
Periodontal parameters
clinical attachment level (CAL)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Jun 2015
- Primary completion15 Mar 2016
- Study completion21 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cankat Kara, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088488
- Sponsor's protocol ID
- OrduUniversity
- Status last verified
- Mar 2017
- First submitted
- 10 Mar 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Bone Metabolism Biomarkers and Serum 25-Hydroxy Vitamin D in Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03088488
- Acronym / sponsor ID
- OrduUniversity
- Conditions
- Alveolar Bone Loss
- Keywords
- 25-OH vitamin D, RANKL, Osteoprotogerin, TNF-α
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 15 Mar 2016 (actual)
- Study completion
- 21 Apr 2016 (actual)
- First posted
- 23 Mar 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.
Vitamin D has become important for periodontal disease due to play a role in autoimmunity, bone mineral metabolism and inflammation. Our aim was to investigate the relation between serum 25-hydroxy vitamin D levels, clinical periodontal parameters and blood serum biomarkers. The subjects were evaluated in 2 groups as chronic periodontitis (n= 30) and periodontally healthy subjects (n= 30). Periodontal parameters and fasting venous blood samples were taken from the subjects to assess each patient's periodontal status and for biochemical analyses (25-hydroxy vitamin D (25-OH vit D), osteoprotegerin (OPG), receptor activator of nuclear kappa B ligand (RANKL), C-telopeptide (CTx), tumor necrosis factor-α (TNF-α)).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontally healthy subjects | – | Diagnostic Test: fasting venous blood samples |
| Chronic periodontitis patients | – | Diagnostic Test: fasting venous blood samples |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sixty patients (35 girls) who were aged between 25-45 years (30.8 (mean) ± 4.9 (standard deviation) and presented to our faculty for periodontal and other dental problems, participated in the study. Subjects were divided in to 2 groups each containing 30 patients: * Group I - periodontal healthy * Group II - untreated chronic periodontitis (radiographic evidence of bone loss and clinical attachment loss in excess of 5 mm in more than six teeth)
Key inclusion criteria (5 listed)
Key exclusion criteria (1 listed)
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 |
|---|---|---|
| fasting venous blood samples | Diagnostic test | Chronic periodontitis patients, Periodontally healthy subjects |
Primary outcome
Biochemical parameters
Time frame: Baseline
serum TNF-α
Biochemical parameters
Time frame: Baseline
serum CTx
Biochemical parameters
Time frame: Baseline
serum RANKL
Biochemical parameters
Time frame: Baseline
serum OPG
Biochemical parameters
Time frame: Baseline
serum 25-OH vitamin D
4 secondary outcomes
Periodontal parameters
Time frame: Baseline
Periodontal parameters
Time frame: Baseline
Periodontal parameters
Time frame: Baseline
Periodontal parameters
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Bone Loss, run by Ordu University.
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 5 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: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical parameters (time frame: Baseline). The study lists 5 primary outcomes in all. 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 23 Mar 2017.