Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.

Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227367
• Other study ID #: MU-107-IEC/2014
• Status: Completed
• Phase: N/A
• First received: June 25, 2017
• Last updated: July 24, 2017
• Start date: March 17, 2014
• Est. completion date: March 18, 2017

Study information

• Verified date: July 2017
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 18, 2017
• Est. primary completion date: April 13, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Resorption
• Chronic Periodontitis
• Gingival Diseases
• Osteoclastic Bone Loss
• Periodontal Bone Loss
• Periodontal Disease
• Periodontal Diseases
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

References & Publications (2)

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 periodon — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probing pocket depth	probing pocket dept was measured using Williams periodontal probe at base line	base line
Secondary	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
Secondary	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