Diabetes (DM)NCT07193979
Relationship Between Diabetes and Periodontitis
An observational study of Diabetes (DM) and Periodontitis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes (DM), Periodontitis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Aug 2025
- 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 23 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Age between 20 and 65 years Diagnosed with Type 2 Diabetes Mellitus (T2DM) Diagnosed with periodontitis, according to established clinical criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Faculty of Dentistry
Afyonkarahisar
About this study
Official title: Relationship Between Diabetes and Periodontal Status and Dental Caries
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.
Read the detailed description
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.
- Conditions
- Diabetes (DM), Periodontitis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | HgA1c <7 diabetic patients | |
| Group 2 | Diabetic patients with HgA1c 7≤ <8 in this range | |
| Group 3 | HgA1c ≥8 diabetic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Index (PI) Score
PI will be used to assess periodontal health, scored according to WHO guidelines (Unit of Measure: Millimeters (mm))
Measured: 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))
Measured: 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))
Measured: 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.
Measured: One-time measurement at the beginning of the study
Secondary outcomes (5)
Bleeding on Probing (BOP)
Bleeding on probing will be measured at six sites per tooth. The percentage of sites showing bleeding upon gentle probing will be recorded.
Measured: One-time measurement at the beginning of the study
Gingival Index (GI)
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.
Measured: One-time measurement at the beginning of the study
Number of Decayed Teeth (D Component of DMFT Index)
The number of decayed teeth will be recorded according to WHO criteria.
Measured: One-time measurement at the beginning of the study
Number of Missing Teeth (M Component of DMFT Index)
The number of missing teeth due to caries will be recorded based on clinical and anamnestic data.
Measured: One-time measurement at the beginning of the study
Number of Filled Teeth (F Component of DMFT Index)
The number of teeth with permanent restorations due to dental caries will be recorded.
Measured: One-time measurement at the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Nov 2024
- Primary completion1 May 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Karaçam, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193979
- Sponsor's protocol ID
- 2024/341
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect participant privacy and act in accordance with the ethics committee decision, individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Diabetes and Periodontal Status and Dental Caries
- ClinicalTrials.gov ID
- NCT07193979
- Acronym / sponsor ID
- 2024/341
- Conditions
- Diabetes (DM), Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 26 Sep 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –HgA1c <7 diabetic patients |
| Group 2 | – | –Diabetic patients with HgA1c 7≤ <8 in this range |
| Group 3 | – | –HgA1c ≥8 diabetic patients |
Who may qualify
- Ages
- 23 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Age between 20 and 65 years Diagnosed with Type 2 Diabetes Mellitus (T2DM) Diagnosed with periodontitis, according to established clinical criteria
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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))
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))
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))
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.
5 secondary outcomes
Bleeding on Probing (BOP)
Time frame: One-time measurement at the beginning of the study
Gingival Index (GI)
Time frame: One-time measurement at the beginning of the study
Number of Decayed Teeth (D Component of DMFT Index)
Time frame: One-time measurement at the beginning of the study
Number of Missing Teeth (M Component of DMFT Index)
Time frame: One-time measurement at the beginning of the study
Number of Filled Teeth (F Component of DMFT Index)
Time frame: One-time measurement at the beginning of the study
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 26 Sep 2025.
- Individual participant dataSharing planned: No. In order to protect participant privacy and act in accordance with the ethics committee decision, individual participant data will not be shared.
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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 Diabetes (DM) and Periodontitis, run by Afyonkarahisar Health Sciences 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 1 inclusion and 1 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 26 Sep 2025. 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?
Periodontal Index (PI) Score (time frame: One-time measurement at the beginning of the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2025.