NCT07193979

Brief Summary

Diabetes mellitus, one of the major global health problems of the 21st century, is a chronic metabolic disease characterized by dysregulated nutrient metabolism resulting from defects in insulin secretion and action. Patients with diabetes mellitus are more likely to develop chronic periodontitis. A bidirectional relationship between diabetes mellitus and periodontitis has been demonstrated. Dental complications of diabetes mellitus include periodontitis and dental caries. Dental caries, resulting from tooth demineralization, are more prevalent in diabetic individuals than in non-diabetic individuals. For adults, HbA1c levels were defined as \<7% ("good" control), HbA1c levels between 7% and 8% as "inadequate" control, and levels above 8% as "poor" control. In the study conducted by the investigators, patients diagnosed with type 2 diabetes mellitus and those diagnosed with periodontitis were grouped according to HbA1C levels, and the relationship between these levels and the stage/degree of periodontitis and the degree of caries was examined. Although studies on periodontal diseases and dental caries among adults with type 2 diabetes mellitus exist in the literature, no study has, as far as is known that classifies HbA1c levels in patients with controlled and uncontrolled diabetes diagnosed with periodontitis and explains the relationship between these groups and the stage/degree of periodontitis and the degree of caries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 12, 2025

Last Update Submit

September 18, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Periodontal Index (PI) Score

    PI will be used to assess periodontal health, scored according to WHO guidelines (Unit of Measure: Millimeters (mm))

    One-time measurement at the beginning of the study

  • Clinical Attachment Loss (CAL)

    Clinical attachment loss will be measured at six sites per tooth using a periodontal probe (Unit of Measure: Millimeters (mm))

    One-time measurement at the beginning of the study

  • Probing Depth (PD)

    Probing depth will be measured at six sites per tooth using a periodontal probe.(Millimeters (mm))

    One-time measurement at the beginning of the study

  • Total DMFT Index Score

    The DMFT index will be calculated by summing the number of decayed (D), missing (M), and filled (F) teeth for each participant, as per WHO guidelines.

    One-time measurement at the beginning of the study

Secondary Outcomes (5)

  • Bleeding on Probing (BOP)

    One-time measurement at the beginning of the study

  • Gingival Index (GI)

    One-time measurement at the beginning of the study

  • Number of Decayed Teeth (D Component of DMFT Index)

    One-time measurement at the beginning of the study

  • Number of Missing Teeth (M Component of DMFT Index)

    One-time measurement at the beginning of the study

  • Number of Filled Teeth (F Component of DMFT Index)

    One-time measurement at the beginning of the study

Study Arms (3)

Group 1

HgA1c \<7 diabetic patients

Group 2

Diabetic patients with HgA1c 7≤ \<8 in this range

Group 3

HgA1c ≥8 diabetic patients

Eligibility Criteria

Age23 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study was conducted among individuals who applied to Afyonkarahisar Health Sciences University Faculty of Dentistry and volunteered to participate in the study.

You may qualify if:

  • Age between 20 and 65 years Diagnosed with Type 2 Diabetes Mellitus (T2DM) Diagnosed with periodontitis, according to established clinical criteria

You may not qualify if:

  • Diagnosis of Type 1 Diabetes Mellitus Diagnosis of gestational diabetes Presence of physical or mental disorders that may affect participation or evaluation Undergoing chemotherapy or radiotherapy Presence of any systemic disease other than diabetes mellitus Use of systemic antibiotics or other medications in the past 3 months Use of antiparkinsonian, antidepressant, or antipsychotic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University Faculty of Dentistry

Afyonkarahisar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusPeriodontitis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assist. prof.

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 26, 2025

Study Start

November 1, 2024

Primary Completion

May 1, 2025

Study Completion

August 1, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

In order to protect participant privacy and act in accordance with the ethics committee decision, individual participant data will not be shared.

Locations