Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients

Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients With and Without Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Inflammation
• Intervention / Treatment: Diagnostic test: saliva analysis for Toll like receptor activity

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Dubai
    • Ajman, Dubai, United Arab Emirates, 009714
      • Ajman University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control patients; Evaluation of Toll like receptor activity from whole saliva obtained from control patients	Diagnostic test: saliva analysis for Toll like receptor activity; Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity
Active Comparator: Periodontal patients without diabetes; Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients without diabetes	Diagnostic test: saliva analysis for Toll like receptor activity; Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity
Active Comparator: Periodontal patients with diabetes; Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients with diabetes	Diagnostic test: saliva analysis for Toll like receptor activity; Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toll like receptor 2 activity	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	From baseline to 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toll like receptor 4 activity	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	From baseline to 5 months

Collaborators and Investigators

• Sponsor: Ajman University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: December 15, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Inflammation
• Other Study ID Numbers: D-F-19-03-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No