Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.

Not Applicable

Completed

• Conditions: Periodontal Disease; Osteoclastic Bone Loss; Periodontal Bone Loss

• Registration Number: NCT03227367
• Lead Sponsor: Meenakshi Ammal Dental College and Hospital

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.

Study Timeline

• Study Start: 2014-03-17
• Primary Completion: 2016-04-13
• Study Completion: 2017-03-18
• Study First Submitted: 2017-06-25
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-24
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
probing pocket depth	base line	probing pocket dept was measured using Williams periodontal probe at base line

Secondary Outcome Measures

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