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
About this trial
This is an interventional diagnostic trial for Periodontal Inflammation
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
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
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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