Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients

Periodontal Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201912
• Other study ID #: D-F-19-03-03
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: December 2019
• Source: Ajman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Periodontal Inflammation
• Periodontitis

Intervention

Diagnostic Test:
• saliva analysis for Toll like receptor activity
Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity

Locations

Country	Name	City	State
United Arab Emirates	Ajman University	Ajman	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Ajman University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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