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Comparing the Saliva and Blood Levels of Inflammatory Markers in Severe Gum disease in patients with Controlled and Un controlled Type 2 Diabetes Mellitus

Comparative evaluation of Salivary and Serum levels of Dipeptidyl Peptidase 4 and Interleukin 12 in Stage III and IV Periodontitis with or without Uncontrolled Type 2 Diabetes Mellitus A Case Control Study - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088040
Enrollment
76
Registered
2025-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K053- Chronic periodontitis

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Dr. Kirubavathi S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group 1Systemically and clinically healthy periodontium 1. Age group greater than 18 years 2. Good systemic health 3. At least 20 natural teeth, excluding the third molars, minimum 10 pairs of antagonistic teeth should be present 4. FMPS greater than or equal to20 percentage 5. FMBS greater than or equal to 10percentage 6. Probing pocket depth greater than or equal to 3mm 7. No clinical attachment loss Group 2 Systemically healthy with Generalised stage III or IV periodontitis. 1.Age group greater than or equal to18 years 2. FMPS less than 20percentage 3.FMBS less than 10 percentage 4.Periodontal probing depth greater than or equal to 6mm 5.Clinical attachment loss greater than or equal to 5mm 6.Radiographic evidence of bone loss extending to the middle or apical third of the root for stage III and IV periodontitis. 7.At least 20 natural teeth, excluding the third molars, minimum 10 pairs of antagonistic teeth should be present Group 3 Generalised stage III and IV periodontitis with uncontrolled Type 2 Diabetes Mellitus HbA1c 8 to 10 percentage 1.Age group greater than or equal to 18 years 2.Periodontal Probing depth greater than or equal to 6mm 3. clinical attachment loss greater than or equal to 5mm 4. FMPS greater than 20 percentage 5. FMBS greater than 10 percentage 6. Tooth loss due to periodontitis greater than 5 teeth 7.Radiographic evidence of bone loss 8.Patients diagnosed with type 2 diabetes mellitus and are on oral hypoglycemic drugs at least for 1 year duration with HbA1c value 8 to 10 percentage Group 4 Generalised stage III or IV Periodontitis with controlled Type 2 Diabetes Mellitus HbA1c greater than or equal to 7 percentage 1. Age group greater than or equal to 18 years 2. At least 20 natural teeth, excluding the third molars, minimum 10 pairs of antagonistic teeth should be present 3. FMPS greater than 20 percentage 4. FMBS greater than10 percentage 5. Probing pocket depth greater than or equal to 6mm 6. clinical attachment loss greater than or equal to 5mm 7. Patients diagnosed with type 2 DM by a diabetologist and are on oral hypoglycemic drugs at least for 1 year duration with HbA1c less than or equal to 7 percentage

Exclusion criteria

Exclusion criteria: 1.Patients under Immunosuppressants, Gliptins Sitagliptin,Vildagliptin,Saxagliptin,Linagliptin,Alogliptin DPP4 inhibitor and or antibiotics and or anti inflammatory medications and or any drugs that could influence the periodontium for the past 6 months. 2.Pregnant or lactating mothers 3.Current and past smokers 4.Previous history of periodontal or orthodontic therapy. 5.Patients with any other systemic diseases. 6.Patients with Uncontrolled diabetes mellitus HbA1c greater than10 percentage 7.Patients with a history of any other systemic disease other than type 2 DM and those diabetic individuals giving a history of diabetic complications, under insulin therapy, and HbA1c level greater than 10 percentage were excluded. 8.Subjects not willing to participate and not willing to give consent.

Design outcomes

Primary

MeasureTime frame
To evaluate the serum and salivary levels of Interleukin12 and DPP4 levels in patients with Generalised stage III or IV Periodontitis both in the presence and absence of uncontrolled T2DM. 2. To compare and correlate the serum and salivary Interleukin 12 and DPP4 levels in patients with Generalised stage III orIV Periodontitis both in the presence and absence of uncontrolled T2DM. Timepoint: Baseline

Secondary

MeasureTime frame
To correlate the serum and salivary levels of Interleukin 12 and DPP4 with the clinical parameters in Generalised stage III or IV Periodontitis with and without uncontrolled T2DM. To evaluate the diagnostic accuracy, sensitivity and specificity, positive and negative value of these biomarkers to discriminate between periodontal health and disease using ROC and AUC.Timepoint: Baseline

Countries

India

Contacts

Public ContactDr Devapriya Appukuttan

SRM Dental College

devapriyamds@gmail.com9840197121

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026