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Completed

NCT Number: NCT04201912

Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajman University

Ajman, Dubai, 009714, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saliva analysis for Toll like receptor activity

Diagnostic Test

Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity

Primary outcomes

  1. Toll like receptor 2 activity

    Time frame: 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 outcomes

  1. Toll like receptor 4 activity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ajman University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2019
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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