Clinical trial NCT04201912: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Inflammation
Lead sponsor: Ajman University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Toll like receptor 2 activity
timeFrame: From baseline to 5 months
Secondary outcomes:
measure: Toll like receptor 4 activity
timeFrame: From baseline to 5 months
Other outcomes:
Locations:
city: Ajman
country: United Arab Emirates
facility: Ajman University
state: Dubai
Study officials:
References: