Role of TLR2 and TLR4 in Stage 2 Periodontitis Patients

NCT04201912 | Completed DMC

• 1 other identifier: D-F-19-03-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Toll like receptor 4 activity

  From baseline to 5 months

Study Arms (3)

control patients

PLACEBO COMPARATOR

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

Diagnostic Test: saliva analysis for Toll like receptor activity

Periodontal patients without diabetes

ACTIVE COMPARATOR

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

Diagnostic Test: saliva analysis for Toll like receptor activity

Periodontal patients with diabetes

ACTIVE COMPARATOR

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

Diagnostic Test: saliva analysis for Toll like receptor activity

Interventions

saliva analysis for Toll like receptor activity DIAGNOSTIC_TEST

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

Periodontal patients with diabetes; Periodontal patients without diabetes; control patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*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

You may not qualify if:

• smoker
• habits such as betel, tobacco chewing
• systemically unstable, Diabetes uncontrolled patients
• haven taken medications in the past 3 months
• Pregnant ladies
• Periodontal involvement

Sponsors & Collaborators

• Ajman University: lead

Study Sites (1)

Ajman University

Ajman, Dubai, 009714, United Arab Emirates

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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)

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 17, 2019
• Study Start: May 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

AE (1)