Vitamin D, HbA1c and Vitamin B12 Levels in Patients

February 23, 2023 updated by: Selcen Ozcan Bulut, Hacettepe University

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:

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

606

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Niğde, Turkey, 06800
        • Nigde Omer Halisdemir University, Dentistry Faculty, Periodontology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with missing data and not allowing data use
  • Smoker
  • The data of pregnant and lactating patients were not included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gingivitis
0% interdental bone loss
Diagnostic test: HbA1c, Vitamin D, Vitamin B12
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.
Stage 1 periodontitis
0-15% interdental bone loss
Diagnostic test: HbA1c, Vitamin D, Vitamin B12
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.
Stage 2 Periodontitis
15-33% interdental bone loss
Diagnostic test: HbA1c, Vitamin D, Vitamin B12
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.
Stage 3 Periodontitis
>33% interdental bone loss with potential for additional tooth loss
Diagnostic test: HbA1c, Vitamin D, Vitamin B12
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.
Stage 4 Periodontitis
>%33 interdental bone loss with potantial for loss of dentition
Diagnostic test: HbA1c, Vitamin D, Vitamin B12
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: t0:baseline
serum Hemoglobin A1c value
t0:baseline
Vitamin D
Time Frame: t0 : baseline
serum Vitamin D value
t0 : baseline
Vitamin B12
Time Frame: t0:baseline
serum Vitamin B12 value
t0:baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2022

Primary Completion (Actual)

October 11, 2022

Study Completion (Actual)

November 11, 2022

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Estimate)

February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/81

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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