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Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients

Primary Purpose

Periodontal Inflammation

Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
saliva analysis for Toll like receptor activity
Sponsored by
Ajman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontal Inflammation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ajman University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

control patients

Periodontal patients without diabetes

Periodontal patients with diabetes

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2019
Last Updated
December 16, 2019
Sponsor
Ajman University
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1. Study Identification

Unique Protocol Identification Number
NCT04201912
Brief Title
Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients
Official Title
Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients With and Without Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Inflammation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control patients
Arm Type
Placebo Comparator
Arm Description
Evaluation of Toll like receptor activity from whole saliva obtained from control patients
Arm Title
Periodontal patients without diabetes
Arm Type
Active Comparator
Arm Description
Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients without diabetes
Arm Title
Periodontal patients with diabetes
Arm Type
Active Comparator
Arm Description
Evaluation of toll like receptor activity from whole saliva obtained from periodontal patients with diabetes
Intervention Type
Diagnostic Test
Intervention Name(s)
saliva analysis for Toll like receptor activity
Intervention Description
Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity
Primary Outcome Measure Information:
Title
Toll like receptor 2 activity
Description
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
Time Frame
From baseline to 5 months
Secondary Outcome Measure Information:
Title
Toll like receptor 4 activity
Description
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
Time Frame
From baseline to 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ajman University
City
Ajman
State/Province
Dubai
ZIP/Postal Code
009714
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients

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