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Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.

Primary Purpose

Periodontal Disease, Periodontal Bone Loss, Osteoclastic Bone Loss

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

other : PRF

About this trial

This is an interventional other trial for Periodontal Disease focused on measuring biomaterials, apoptosis, bone regeneration

Eligibility Criteria

25 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Test group

control group

Arm Description

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.

Mononuclear cells isolated from the peripheral blood of healthy individuals in-vitro.

Outcomes

Primary Outcome Measures

probing pocket depth

probing pocket dept was measured using Williams periodontal probe at base line

Secondary Outcome Measures

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

The activity of caspase-3 in OCs.

The activity of caspase-3 was seen in OCs in all the groups

Full Information

NCT ID

NCT03227367

First Posted

June 25, 2017

Last Updated

July 24, 2017

Sponsor

Meenakshi Ammal Dental College and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03227367

Brief Title

Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

March 17, 2014 (Actual)

Primary Completion Date

April 13, 2016 (Actual)

Study Completion Date

March 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Meenakshi Ammal Dental College and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Disease, Periodontal Bone Loss, Osteoclastic Bone Loss

Keywords

biomaterials, apoptosis, bone regeneration

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

Arm Title

control group

Arm Type

Other

Arm Description

Mononuclear cells isolated from the peripheral blood of healthy individuals in-vitro.

Intervention Type

Other

Intervention Name(s)

other : PRF

Other Intervention Name(s)

others : BCP, others : PRF/BCP combination

Intervention Description

mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination

Primary Outcome Measure Information:

Title

probing pocket depth

Description

probing pocket dept was measured using Williams periodontal probe at base line

Time Frame

base line

Secondary Outcome Measure Information:

Title

Protein expression on osteoclast cells was estimated with BCP, PRF alone and BCP/PRF combination.

Description

Protein expression on cells was analyzed using Western blot in all the groups

Time Frame

24 hours from baseline

Title

The activity of caspase-3 in OCs.

Description

The activity of caspase-3 was seen in OCs in all the groups

Time Frame

24 hours from base line

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

shila samuel, MS, PhD

Organizational Affiliation

VRR diagnostic institute chennai

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

jaideep mahendra, MDS,PhD

Organizational Affiliation

meenakshi ammal dental college chennai

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22624763

Citation

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.

Results Reference

result

PubMed Identifier

16848983

Citation

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.

Results Reference

result

Learn more about this trial

Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.

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