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Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients

NCT ID: NCT04201912

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-09-01

Brief Summary

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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

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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.

Conditions

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Periodontal Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Selection of patients by grading the patients according to criteria patients without periodontal and systemic involvement(control), patients classified as stage 2 periodontitis without systemic involvement(test group1), patients classified as stage 2 Periodontitis with systemic disease(Type 2 diabetes)
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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control patients

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

Group Type PLACEBO_COMPARATOR

saliva analysis for Toll like receptor activity

Intervention Type DIAGNOSTIC_TEST

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

Periodontal patients without diabetes

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

Group Type ACTIVE_COMPARATOR

saliva analysis for Toll like receptor activity

Intervention Type DIAGNOSTIC_TEST

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

Periodontal patients with diabetes

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

Group Type ACTIVE_COMPARATOR

saliva analysis for Toll like receptor activity

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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saliva analysis for Toll like receptor activity

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajman University

OTHER

Sponsor Role lead

Responsible Party

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sudhir rama varma

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ajman University

Ajman, Dubai, United Arab Emirates

Site Status

Countries

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United Arab Emirates

Other Identifiers

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D-F-19-03-03

Identifier Type: -

Identifier Source: org_study_id