Clinical trial NCT03227367: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Periodontal Bone Loss
Osteoclastic Bone Loss
Keywords: biomaterials
apoptosis
bone regeneration
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: probing pocket depth
timeFrame: base line
Secondary outcomes:
measure: Protein expression on osteoclast cells was estimated with BCP, PRF alone and BCP/PRF combination.
timeFrame: 24 hours from baseline
measure: The activity of caspase-3 in OCs.
timeFrame: 24 hours from base line
Other outcomes:
Locations:
Study officials:
affiliation: VRR diagnostic institute chennai
name: shila samuel, MS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: meenakshi ammal dental college chennai
name: jaideep mahendra, MDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.