Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients

Not Applicable

Completed

• Conditions: Periodontal Inflammation
• Interventions: Diagnostic Test: saliva analysis for Toll like receptor activity

• Registration Number: NCT04201912
• Lead Sponsor: Ajman University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-15
• Last Update Submitted: 2019-12-16
• Study First Posted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control patients	saliva analysis for Toll like receptor activity	Evaluation of Toll like receptor activity from whole saliva obtained from control patients
Periodontal patients without diabetes	saliva analysis for Toll like receptor activity	Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients without diabetes
Periodontal patients with diabetes	saliva analysis for Toll like receptor activity	Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients with diabetes

Primary Outcome Measures

Name	Time	Method
Toll like receptor 2 activity	From baseline to 5 months	Toll like receptor 2 activity will be measured from saliva obtained from controls, patients with periodontal disease but no diabetes and periodontal patients with diabetes

Secondary Outcome Measures

Name	Time	Method
Toll like receptor 4 activity	From baseline to 5 months	Toll like receptor 4 activity will be measured from saliva obtained from controls, patients with periodontal disease but no diabetes and periodontal patients with diabetes

Trial Locations

Locations (1)

Ajman University; 🇦🇪 Ajman, Dubai, United Arab Emirates