Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases

Study Overview
=================
Brief Summary
-----------------
This study evaluates the levels of biomarkers associated with bone metabolism in patients with different periodontal conditions.

Detailed Description
-----------------
Background: In this study, the levels of bone metabolism markers found in the saliva of individuals with different periodontal conditions were compared and the relationship of these markers with periodontal status was examined. Method: A total of 60 individuals, 20 with periodontitis (P), 20 with gingivitis (G), and 20 with periodontal healthy (S), were included in the study. Periodontal clinical parameters (plaque index, gingival index, bleeding on probing, clinical attachment level and probing pocket depth) and saliva samples were obtained from the individuals. Bone metabolism biomarker (necrotizing factor (TNF)-α, osteoprotegerin (OPG), nuclear factor kappa-β receptor activator ligand (RANKL) and sclerostin) levels in saliva samples were evaluated by enzyme-linked immunosorbent assay (ELISA).

Official Title
-----------------
Evaluation Of Biomarkers Associated With Bone Metabolism İn Patients With Different Periodontal Status

Conditions
-----------------
Periodontal Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: ELISA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old. not having any systemic disease that may affect periodontal status not smoking and alcohol use volunteer to participate in the study Exclusion Criteria: periapical pathologies; resulting from orthodontics and occlusion extreme forces, including mechanical forces; chronic high-dose steroid therapy; radiation or immunosuppressive therapy; pregnancy; breastfeeding; allergy or sensitivity to any medication. Periodontal therapy or drug therapy for at least 6 months of study participants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: periodontitis<br> | Diagnostic Test: ELISA<br>* ELISA(enzyme-linked immunosorbent assay)<br>|
| Experimental: gingivitis<br> | Diagnostic Test: ELISA<br>* ELISA(enzyme-linked immunosorbent assay)<br>|
| Experimental: periodontal healthy<br> | Diagnostic Test: ELISA<br>* ELISA(enzyme-linked immunosorbent assay)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of bone metabolism biomarkers in different periodontal conditions | The levels of bone metabolism markers in the saliva of individuals with different periodontal status were compared and the relationship of these markers with periodontal status was examined. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth | Probing pocket depth(PPD) was measured for determining the severity of the disease and clinical outcome. High probing depth shows more severe periodontal disease. | baseline | 
| Gingival index | The differences in gingival index scores between periodontally healthy and periodontitis.The gingival index was recorded for determining and classifying gingival status. The gingival index (Gİ) scores each site on a 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling and spontaneous bleeding. | baseline | 
| Plaque index | The differences in plaque index scores between periodontally healthy and periodontitis. Plaque index (PI) was recorded for determining and classifying oral hygiene status. The plaque index (PI) scores each site on a with 0 being no plaque in gingival area and 3 abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontitis, saliva, sclerostin