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CompletedNCT03227367Updated Jul 26, 2017

Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.

An interventional study of other : PRF in Periodontal Disease, Periodontal Bone Loss and Osteoclastic Bone Loss, sponsored by Meenakshi Ammal Dental College and Hospital. Completed. Open to participants aged 25 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-26.

Sponsored by Meenakshi Ammal Dental College and Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Mar 2014, registered Jun 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
25 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periodontal Disease
  • Periodontal Bone Loss
  • Osteoclastic Bone Loss

Keywords

  • biomaterials
  • apoptosis
  • bone regeneration
03

In context

Alveolar Bone Loss

297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.

This study's enrollment of 50 is above the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

Meenakshi Ammal Dental College and Hospital is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

  • Other
    control group

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

    Other: other : PRF

Interventions

  • Otherother : PRF

    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

06

What researchers measure

Primary outcomes

  1. probing pocket depth

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

    Time frame: base line

Secondary outcomes

  1. 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

    Time frame: 24 hours from baseline

  2. The activity of caspase-3 in OCs.

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

    Time frame: 24 hours from base line

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 22624763 ↗
  • 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. PubMed 16848983 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03227367
Lead sponsor
Meenakshi Ammal Dental College and Hospital
Responsible party
Dr.Jaideep Mahendra (Professor, Director post graduate studies, Meenakshi Ammal Dental College and Hospital) — Principal investigator
First posted
Jul 24, 2017
Start date
Mar 17, 2014
Primary completion
Apr 13, 2016
Completion
Mar 18, 2017
Last update
Jul 26, 2017

Study contacts

shila samuel, MS, PhD
principal investigator · VRR diagnostic institute chennai
jaideep mahendra, MDS,PhD
principal investigator · meenakshi ammal dental college chennai

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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