Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Bone Loss; Periodontal Disease; Osteoclastic Bone Loss
• Intervention / Treatment: Other: other : PRF

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test group; 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; mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination; Other Names: others : BCP; others : PRF/BCP combination
OTHER: control group; Mononuclear cells isolated from the peripheral blood of healthy individuals in-vitro.	Other: other : PRF; mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination; Other Names: others : BCP; 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

Collaborators and Investigators

• Sponsor: Meenakshi Ammal Dental College and Hospital
• Investigators: Principal Investigator: shila samuel, MS, PhD, VRR diagnostic institute chennai; Principal Investigator: jaideep mahendra, MDS,PhD, meenakshi ammal dental college chennai

Publications and helpful links

General Publications

• Wu CL, Lee SS, Tsai CH, Lu KH, Zhao JH, Chang YC. Platelet-rich fibrin increases cell attachment, proliferation and collagen-related protein expression of human osteoblasts. Aust Dent J. 2012 Jun;57(2):207-12. doi: 10.1111/j.1834-7819.2012.01686.x.
• Colucci S, Mori G, Brunetti G, Coricciati M, Pignataro P, Oranger A, Cirulli N, Mastrangelo F, Grassi FR, Grano M. Interleukin-7 production by B lymphocytes affects the T cell-dependent osteoclast formation in an in vitro model derived from human periodontitis patients. Int J Immunopathol Pharmacol. 2005 Jul-Sep;18(3 Suppl):13-9.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2014
• Primary Completion (ACTUAL): April 13, 2016
• Study Completion (ACTUAL): March 18, 2017

Study Registration Dates

• First Submitted: June 25, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (ACTUAL): July 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: apoptosis; biomaterials; bone regeneration
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Periodontitis; Bone Resorption; Periodontal Diseases; Chronic Periodontitis; Alveolar Bone Loss
• Other Study ID Numbers: MU-107-IEC/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No