Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.

Study Overview
=================
Brief Summary
-----------------
The present study is an effort to investigate the hypothesis that Platelet Rich Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation and in bone loss.

Detailed Description
-----------------
Study design Fifty-five individuals from a suburban population were recruited. Out of them, 5 individuals refused to participate in the study. Finally, 50 participants were selected and divided into two groups, control group [Healthy individuals]: 25 Males/Females, aged 25 to 35 years and test group [Chronic periodontitis patients]: 25 Males/Females aged 30 to 45 years. Demographic variables and periodontal parameters were measured in both the groups.The investigators explored the effect of Platelet rich fibrin (PRF)/Biphasic calcium phosphate (BCP) on differentiation and survival of osteoclasts obtained from peripheral blood of Chronic Periodontitis patients.

Official Title
-----------------
Platelet Rich Fibrin/Biphasic Calcium Phosphate Impairs Osteoclasts Differentiation and Promotes Apoptosis by the Intrinsic Mitochondrial Pathway in Chronic Periodontitis

Conditions
-----------------
Periodontal Disease, Periodontal Bone Loss, Osteoclastic Bone Loss

Intervention / Treatment
-----------------
* Other: other : PRF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: (Control group) Subjects with age group between 30 to 45 years. Non-smokers. No previous history of periodontal treatment. Inclusion Criteria: (Test group) Subjects with age group between 30 to 45 years. Presence of atleast 20 teeth More than 30% of the sites with clinical attachment loss. Non-smokers. No previous history of periodontal treatment. Exclusion Criteria: ( both the groups) Individuals with systemic disease Subjects under antibiotics or anti-inflammatory drugs within the previous 3 months. Pregnant and lactating women. Allergic to antibiotics.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group: (Healthy individuals) comprised of 25 participants with clinically healthy periodontium. Test group: (Chronic periodontitis patients) comprised of 25 participants with signs of clinical inflammation and bone loss.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Mononuclear cells isolated from the peripheral blood of 25 chronic periodontitis patients were interveened with 1ml/well preparation of Platelet rich fibrin(PRF), Biphasic calcium phosphate (BCP) and PRF and BCP combination in-vitro. | Other: other : PRF<br>* mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination<br>* Other names: others : PRF/BCP combination;|
| Other: control group<br>Mononuclear cells isolated from the peripheral blood of healthy individuals in-vitro. | Other: other : PRF<br>* mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination<br>* Other names: others : PRF/BCP combination;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing pocket depth | probing pocket dept was measured using Williams periodontal probe at base line | base line | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein expression on osteoclast cells was estimated with BCP, PRF alone and BCP/PRF combination. | Protein expression on cells was analyzed using Western blot in all the groups | 24 hours from baseline | 
| The activity of caspase-3 in OCs. | The activity of caspase-3 was seen in OCs in all the groups | 24 hours from base line | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
apoptosis, bone regeneration, biomaterials