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

Not yet recruiting

Conditions: Chronic periodontitis,

Registration Number: CTRI/2025/06/088040

Lead Sponsor: Dr. Kirubavathi S

Brief Summary: Periodontitis is a chronic inflammatory disease initiated by microbial biofilm and sustained by the hosts immune response, leading to progressive destruction of periodontal tissues. Type 2 diabetes mellitus significantly increases the risk of periodontitis, while periodontitis, in turn, negatively affects glycemic control, indicating a bidirectional relationshipT2DM influences periodontitis by promoting a hyperinflammatory state, impairing bone healing, and increasing advanced glycation end products Interleukin12 plays a central role in immune modulation by promoting Th1 cell differentiation, enhancing IFN gamma production, and linking innate and adaptive immunity. Elevated IL12 levels have been observed in periodontitis, with correlations to disease severity, though findings remain inconsistent across studies.Dipeptidyl peptidase 4 regulated by IL12, enhances Tcell responses, contributes to insulin resistance by degrading incretin hormones, and is involved in oxidative stress and osteoclastogenesis. Increased levels of DPP4 have been found in gingival crevicular fluid and saliva of periodontitis patients, though its role in T2D Massociated periodontitis remains unexplored.

Despite the known individual roles of IL 12 and DPP4 in T2DM and periodontitis, their combined contribution and interaction in T2DM associated periodontitis have not been studied. This study aims to evaluate salivary and serum levels of IL12 and DPP4 in periodontitis with and without T2DM. We hypothesize that in uncontrolled T2DMassociated periodontitis, both IL12 and DPP4 levels are elevated and positively correlated, contributing to enhanced immune dysregulation and tissue destruction.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 76

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.
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.
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.
FMBS greater than10 percentage 5.
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

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Baseline
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.	Baseline

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1): SRM Dental College
🇮🇳
Chennai, TAMIL NADU, India
SRM Dental College
🇮🇳Chennai, TAMIL NADU, India
DrKirubavathi S
Principal investigator
6381718406
kirubavathisivasubramani8@gmail.com