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NCT Number: NCT07193979

Relationship Between Diabetes and Periodontitis

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.

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Key information

Age range

23 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Afyonkarahisar Health Sciences University Faculty of Dentistry

Afyonkarahisar, Turkey (Türkiye)

About this study

Mechanisms by which diabetes mellitus affects the periodontium have been reported, including altering host immune, inflammatory, and wound-healing responses, promoting the accumulation of advanced glycation end products, and inducing elevated levels of proinflammatory cytokines. Periodontitis is a common chronic infectious disease that can lead to the destruction of periodontal supporting tissues. Pathologically, a hyperactive inflammatory response contributes to the progression of these two diseases. Diabetes mellitus, in particular, increases the risk of periodontitis by activating immune and inflammatory responses in periodontal tissues. These active responses lead to increased cytokine secretion, increased oxidative damage, and impaired receptor-mediated signaling. All of these events accelerate the breakdown of periodontal connective tissue and alveolar bone resorption, thereby exacerbating periodontitis. Conversely, periodontitis can lead to deranged glycemic control in diabetic patients. Dental complications of diabetes mellitus include periodontitis and dental caries. Dental caries, resulting from tooth demineralization, is more prevalent in diabetic individuals than in non-diabetic individuals. The combination of carbohydrate intake and insulin deficiency leads to hyposalivation and higher salivary glucose levels, both of which contribute to an increased risk of dental caries. Factors that increase the risk of dental caries include decreased plaque microbial flora, decreased buffering and cleansing activities of saliva, decreased salivary flow rate, and decreased calcium levels. Glycemic control can be measured in various ways. For this study, researchers focused on glycated hemoglobin (HbA1c), which represents the average blood glucose levels over the previous 3 months. The study examined the relationship between the severity of periodontitis and the DMFT index according to HgA1C levels in diabetic patients. To our knowledge, no studies in the literature have classified HbA1c levels in patients with and without periodontitis, explaining the relationship between these groups and the stage/degree of periodontitis and the degree of caries. A standard periodontal examination was performed on the volunteers included in the study, and the gingival index (GI) (Loe & Silness, 1963 ), plaque index (PI) (Silness & Loe, 1964 ), probing depth (PD), bleeding on probing (BOP) (Ainamo & Bay, 1975 ), and clinical attachment level (CAL) were determined at six sites for each tooth except the third molars. The Decayed, Missing, and Filled Teeth (DMFT) index, declared by the World Health Organization, is an indicator of caries experience. During the intraoral examination, the total number of teeth and the status of teeth and fillings were recorded. Decayed teeth were examined visually and by radiographs. The numbers of decayed teeth (DT), missing teeth (MT), and filled teeth (FT) were recorded, and the DMFT index was calculated as the sum of DT+MT+FT.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Periodontal Index (PI) Score

    Time frame: One-time measurement at the beginning of the study

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

  2. Clinical Attachment Loss (CAL)

    Time frame: One-time measurement at the beginning of the study

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

  3. Probing Depth (PD)

    Time frame: One-time measurement at the beginning of the study

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

  4. Total DMFT Index Score

    Time frame: One-time measurement at the beginning of the study

    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.

Secondary outcomes

  1. Bleeding on Probing (BOP)

    Time frame: One-time measurement at the beginning of the study

    Bleeding on probing will be measured at six sites per tooth. The percentage of sites showing bleeding upon gentle probing will be recorded.

  2. Gingival Index (GI)

    Time frame: One-time measurement at the beginning of the study

    Gingival inflammation will be assessed using the Löe and Silness Gingival Index, which scores the severity of gingivitis on a scale from 0 to 3.

  3. Number of Decayed Teeth (D Component of DMFT Index)

    Time frame: One-time measurement at the beginning of the study

    The number of decayed teeth will be recorded according to WHO criteria.

  4. Number of Missing Teeth (M Component of DMFT Index)

    Time frame: One-time measurement at the beginning of the study

    The number of missing teeth due to caries will be recorded based on clinical and anamnestic data.

  5. Number of Filled Teeth (F Component of DMFT Index)

    Time frame: One-time measurement at the beginning of the study

    The number of teeth with permanent restorations due to dental caries will be recorded.

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

Relationship Between Diabetes and Periodontal Status and Dental Caries

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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