NCT03227367

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

June 25, 2017

Last Update Submit

July 24, 2017

Conditions

Periodontal DiseasePeriodontal Bone LossOsteoclastic Bone Loss

Keywords

biomaterialsapoptosisbone regeneration

Outcome Measures

Primary Outcomes (1)

  • probing pocket depth

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

    base line

Secondary Outcomes (2)

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

    24 hours from baseline

  • The activity of caspase-3 in OCs.

    24 hours from base line

Study Arms (2)

Test group

EXPERIMENTAL

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

control group

OTHER

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

Other: other : PRF

Interventions

other : PRFOTHER

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

Also known as: others : BCP, others : PRF/BCP combination
Test groupcontrol group

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with age group between 30 to 45 years.
  • Non-smokers.
  • No previous history of periodontal treatment.
  • 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.

You may not qualify if:

  • Individuals with systemic disease
  • Subjects under antibiotics or anti-inflammatory drugs within the previous 3 months.
  • Pregnant and lactating women.
  • Allergic to antibiotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 22624763RESULT

  • 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.

    PMID: 16848983RESULT

MeSH Terms

Conditions

Periodontal DiseasesAlveolar Bone LossBone Resorption

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Study Officials

  • shila samuel, MS, PhD

    VRR diagnostic institute chennai

    PRINCIPAL INVESTIGATOR

  • jaideep mahendra, MDS,PhD

    meenakshi ammal dental college chennai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director post graduate studies

Study Record Dates

First Submitted

June 25, 2017

First Posted

July 24, 2017

Study Start

March 17, 2014

Primary Completion

April 13, 2016

Study Completion

March 18, 2017

Last Updated

July 26, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share