Serum HbA1c and Vitamin D, Vitamin B12 Values in Periodontal DiseasesNCT05745779
Vitamin D, HbA1c and Vitamin B12 Levels in Patients
An observational study of Serum HbA1c and Vitamin D, Vitamin B12 Values in Periodontal Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Abstract Aim: to compare the serum vitamin D, HbA1c and vitamin B12 levels in patients with gingivitis and four different periodontitis stages diagnosed according to the 2017 Periodontal Disease Classification. Materials and methods: A total of 606 (378 Female, 228 Male) patients were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Serum HbA1c and Vitamin D, Vitamin B12 Values in Periodontal Diseases
- What is being tested?
- HbA1c, Vitamin D, Vitamin B12
- How many people
- 606 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Aug 2022to 11 Nov 2022
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients between the ages of 18-80, who applied to the clinic due to periodontal disease, and had serum HbA1c, vitamin D, vitamin B12 values in the hospital archive within 3 months from the date of clinical application.
Who may be able to join
- Patients diagnosed with gingivitis or periodontitis with complete periodontal diagnostic data (Gingival Index(Löe, 1967), Plaque Index(Löe, 1967), Periodontal pocket depths(PD), Clinical Attachment loss (CAL), Radiological data- Interdental Bone loss (IBL) data
- Non-smoker
- Vit D, HbA1c and B12 vit in blood on the date of application to the clinic and/or in the last 3 months. Patients with data on values were included in the study.
Who cannot join
- Patients with missing data and not allowing data use
- Smoker
- The data of pregnant and lactating patients were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nigde Omer Halisdemir University, Dentistry Faculty, Periodontology Department
Niğde, 06800
About this study
Official title: Serum Vitamin D, HbA1c and Vitamin B12 Levels in Patients With Gingivitis and Periodontitis Stages
Abstract Aim: to compare the serum vitamin D, HbA1c and vitamin B12 levels in patients with gingivitis and four different periodontitis stages diagnosed according to the 2017 Periodontal Disease Classification.
Materials and methods: A total of 606 (378 Female, 228 Male) patients were included in the study. The periodontal status of the patients was diagnosed with gingivitis, stage 1,2,3 and 4 periodontitis groups were formed. HbA1c, vitamin D and vitamin B12 values of the patients were compared and analyzed.
Result:
Conclusion:
Read the detailed description
bstract Aim: to compare the serum vitamin D, HbA1c and vitamin B12 levels in patients with gingivitis and four different periodontitis stages diagnosed according to the 2017 Periodontal Disease Classification as determined by the American Academy of Periodontology and the European Federation of Periodontology (AAP-EFP) Materials and methods: A total of 606 (378 Female, 228 Male) patients were included in the study. The periodontal status of the patients was diagnosed with gingivitis, stage 1,2,3 and 4 periodontitis groups were formed. HbA1c, vitamin D and vitamin B12 values of the patients were compared and analyzed.
- Being tested
- HbA1c, Vitamin D, Vitamin B12
- Keywords
- Diabetes Mellitus, Periodontitis, Risk Factors, Vitamin
- Medical subject headings
- Diabetes Mellitus, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HbA1c, Vitamin D, Vitamin B12Diagnostic test
Serum HbA1c, Vitamin D, Vitamin B12 values of the patients who applied for gingival treatment in the last 3 months from the date of application were found from the hospital archive and serum was not taken from the patients again for the study.
| Study group | Role | What they receive |
|---|---|---|
| Gingivitis | 0% interdental bone loss Receives: Diagnostic Test: HbA1c, Vitamin D, Vitamin B12 | |
| Stage 1 periodontitis | 0-15% interdental bone loss Receives: Diagnostic Test: HbA1c, Vitamin D, Vitamin B12 | |
| Stage 2 Periodontitis | 15-33% interdental bone loss Receives: Diagnostic Test: HbA1c, Vitamin D, Vitamin B12 | |
| Stage 3 Periodontitis | >33% interdental bone loss with potential for additional tooth loss Receives: Diagnostic Test: HbA1c, Vitamin D, Vitamin B12 | |
| Stage 4 Periodontitis | >%33 interdental bone loss with potantial for loss of dentition Receives: Diagnostic Test: HbA1c, Vitamin D, Vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
serum Hemoglobin A1c value
Measured: t0:baseline
Vitamin D
serum Vitamin D value
Measured: t0 : baseline
Vitamin B12
serum Vitamin B12 value
Measured: t0:baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start11 Aug 2022
- Primary completion11 Oct 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Serum HbA1c and Vitamin D, Vitamin B12 Values in Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selcen Ozcan Bulut, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745779
- Sponsor's protocol ID
- 2022/81
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
PubMed 29926952Bulut SO, Noyun D, Dirikan Ipci S, Cakar G. Serum vitamin D, hemoglobin A1c and vitamin B12 levels in patients with gingivitis and periodontitis stages. Biomark Med. 2024;18(9):449-457. doi: 10.1080/17520363.2024.2342236. Epub 2024 May 17.
PubMed 39007836
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Vitamin D, HbA1c and Vitamin B12 Levels in Patients With Gingivitis and Periodontitis Stages
- ClinicalTrials.gov ID
- NCT05745779
- Acronym / sponsor ID
- 2022/81
- Keywords
- Diabetes Mellitus, Periodontitis, Risk Factors, Vitamin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 27 Feb 2023 (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.
Abstract Aim: to compare the serum vitamin D, HbA1c and vitamin B12 levels in patients with gingivitis and four different periodontitis stages diagnosed according to the 2017 Periodontal Disease Classification.
Materials and methods: A total of 606 (378 Female, 228 Male) patients were included in the study. The periodontal status of the patients was diagnosed with gingivitis, stage 1,2,3 and 4 periodontitis groups were formed. HbA1c, vitamin D and vitamin B12 values of the patients were compared and analyzed.
Result:
Conclusion:
Detailed description
bstract Aim: to compare the serum vitamin D, HbA1c and vitamin B12 levels in patients with gingivitis and four different periodontitis stages diagnosed according to the 2017 Periodontal Disease Classification as determined by the American Academy of Periodontology and the European Federation of Periodontology (AAP-EFP) Materials and methods: A total of 606 (378 Female, 228 Male) patients were included in the study. The periodontal status of the patients was diagnosed with gingivitis, stage 1,2,3 and 4 periodontitis groups were formed. HbA1c, vitamin D and vitamin B12 values of the patients were compared and analyzed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gingivitis | – | Diagnostic Test: HbA1c, Vitamin D, Vitamin B120% interdental bone loss |
| Stage 1 periodontitis | – | Diagnostic Test: HbA1c, Vitamin D, Vitamin B120-15% interdental bone loss |
| Stage 2 Periodontitis | – | Diagnostic Test: HbA1c, Vitamin D, Vitamin B1215-33% interdental bone loss |
| Stage 3 Periodontitis | – | Diagnostic Test: HbA1c, Vitamin D, Vitamin B12>33% interdental bone loss with potential for additional tooth loss |
| Stage 4 Periodontitis | – | Diagnostic Test: HbA1c, Vitamin D, Vitamin B12>%33 interdental bone loss with potantial for loss of dentition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-80, who applied to the clinic due to periodontal disease, and had serum HbA1c, vitamin D, vitamin B12 values in the hospital archive within 3 months from the date of clinical application.
Key inclusion criteria (3 listed)
- Patients diagnosed with gingivitis or periodontitis with complete periodontal diagnostic data (Gingival Index(Löe, 1967), Plaque Index(Löe, 1967), Periodontal pocket depths(PD), Clinical Attachment loss (CAL), Radiological data- Interdental Bone loss (IBL) data
- Non-smoker
- Vit D, HbA1c and B12 vit in blood on the date of application to the clinic and/or in the last 3 months. Patients with data on values were included in the study.
Key exclusion criteria (3 listed)
- Patients with missing data and not allowing data use
- Smoker
- The data of pregnant and lactating patients were not included in the study.
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 |
|---|---|---|
| HbA1c, Vitamin D, Vitamin B12Serum HbA1c, Vitamin D, Vitamin B12 values of the patients who applied for gingival treatment in the last 3 months from the date of application were found from the hospital archive and serum was not taken from the patients again for the study. | Diagnostic test | Gingivitis, Stage 1 periodontitis, Stage 2 Periodontitis, Stage 3 Periodontitis, Stage 4 Periodontitis |
Primary outcome
HbA1c
Time frame: t0:baseline
serum Hemoglobin A1c value
Vitamin D
Time frame: t0 : baseline
serum Vitamin D value
Vitamin B12
Time frame: t0:baseline
serum Vitamin B12 value
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 27 Feb 2023.
- Background: PubMed 29926952Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
- Derived from this study: PubMed 39007836Bulut SO, Noyun D, Dirikan Ipci S, Cakar G. Serum vitamin D, hemoglobin A1c and vitamin B12 levels in patients with gingivitis and periodontitis stages. Biomark Med. 2024;18(9):449-457. doi: 10.1080/17520363.2024.2342236. Epub 2024 May 17.
- Individual participant dataSharing planned: No
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.
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 Serum HbA1c and Vitamin D, Vitamin B12 Values in Periodontal Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 27 Feb 2023. 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 Turkey (Türkiye). 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?
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?
HbA1c (time frame: t0:baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745779, which also lists 2 linked publications.
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 27 Feb 2023.