Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients

Ajman University

Status: Completed

Conditions: Periodontal Inflammation

Treatments: Diagnostic Test: saliva analysis for Toll like receptor activity

Study type: Interventional

Funder types: Other

Identifiers

NCT04201912

D-F-19-03-03

Details and patient eligibility

About

In Health, mucosal inflammation is prevented by TLR (Toll like receptors) that interact with Specific MAMP (microbe associated molecular pattern). Currently about 13TLRs have been identified. Among them, TLR2 and 4 recognize most organisms . Periodontal disease is mixed infection resulting due to dysbiosis . When aggravated by systemic disease the role of TLRs is detrimental for the overall state of periodontal apparatus. Type 2 diabetes is one of the systemic disease which is seen a risk factor if uncontrolled can exaggerate the titer of TLR2 and TLR4 biomarkers . Various studies have been evaluated to determine the role of TLRs in autoimmune and periodontal conditions. The purpose of this study is to determine if both TLR2 and TLR4 play equal roles in periodontal disease and in cases where periodontal disease is complicated by the presence of systemic disease. Individual role of TLR2 and TLR4 in active disease will help determine treatment strategies and will also be able to predict potential biomarker in disease.

Full description

In Health, mucosal inflammation is prevented by TLR (Toll like receptors) that interact with Specific MAMP (microbe associated molecular pattern). Currently about 13TLRs have been identified. Among them, TLR2 and 4 recognize most organisms. Periodontal disease is mixed infection resulting due to dysbiosis. When aggravated by systemic disease the role of TLRs is detrimental for the overall state of periodontal apparatus. Type 2 diabetes is one of the systemic disease which is seen a risk factor if uncontrolled can exaggerate the titer of TLR2 and TLR4 biomarkers. Various studies have been evaluated to determine the role of TLRs in autoimmune and periodontal conditions. The purpose of this study is to determine if both TLR2 and TLR4 play equal roles in periodontal disease and in cases where periodontal disease is complicated by the presence of systemic disease. Individual role of TLR2 and TLR4 in active disease will help determine treatment strategies and will also be able to predict potential biomarker in disease.

Periodontal diseases are classified according to the American academy of periodontology as stage 1, 2, 3&4 according to severity and extent of the disease progression.

Stage 2 periodontitis was selected as it is considered as an intermediary, because CAL(clinical attachment loss was standardized at 3-4mm,this could reflect the progression of disease and its impact from a horizontal bone loss to a more oblique one, if in case the dysbiosis persists.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• *Untreated stage 2 periodontitis patients (n-60)-Age group 21-60

  • Non Smokers
  • Diabetic patients controlled
  • Not haven taken medications in the past 3 months

Exclusion criteria

• smoker

  • habits such as betel, tobacco chewing
  • systemically unstable, Diabetes uncontrolled patients
  • haven taken medications in the past 3 months
  • Pregnant ladies
  • Periodontal involvement

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups, including a placebo group

control patients

Placebo Comparator group

Description:

Evaluation of Toll like receptor activity from whole saliva obtained from control patients

Treatment:

Diagnostic Test: saliva analysis for Toll like receptor activity

Periodontal patients without diabetes

Active Comparator group

Description:

Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients without diabetes

Treatment:

Diagnostic Test: saliva analysis for Toll like receptor activity

Periodontal patients with diabetes

Active Comparator group

Description:

Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients with diabetes

Treatment:

Diagnostic Test: saliva analysis for Toll like receptor activity