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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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