Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

Efficacy Of Platelet Rich Fibrin With 1% Alendronate For Treatment Of Intrabony Defects In Chronic Periodontitis: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518152
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014N
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 4, 2015
• Last updated: August 6, 2015
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1% Alendronate (ALN) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients.

Description:

Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate, act as reservoirs of growth factors and cytokines which are the key factors for regeneration of the bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The present study was designed to evaluate the combined efficacy of PRF and 1% ALN with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients.

Methods: Ninety patients with single defects were categorized into three groups: OFD alone, OFD with PRF,OFD with PRF+1% ALN. Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction (IBD) was evaluated at baseline and 9 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

Inclusion criteria

• Presence of 3-wall IBD =3 mm deep (distance between alveolar crest and base of the defect on an Intra-oral Periapical Radiograph [IOPA]) along with an interproximal probing depth (PD) =5 mm after phase I therapy (scaling and root planing[SRP]) in asymptomatic teeth.

Exclusion Criteria:

• Aggressive Periodontitis patients;

• Systemic conditions known to affect the periodontal status;

• medications known to affect the outcomes of periodontal therapy;

• Hematological disorders and insufficient platelet count (<200,000/mm3);

• Pregnancy/lactation;

• Smoking and tobacco use in any form

• Immunocompromised individuals.

• Those having unacceptable oral hygiene (plaque index27 [PI] >1.5) after reevaluation of Phase I therapy .

• Teeth with furcation involvement, non-vital teeth, carious teeth indicated for restorations and mobility of at least grade II were also excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• Open flap debridement (OFD)
Oral prophylaxis followed by Open flap debridement (OFD)
• OFD with Platelet rich fibrin (PRF)
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
• OFD with Platelet rich fibrin (PRF)+1% Alendronate
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate placement into the bone defect

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	defect depth reduction (%)	assessed in percentage	Change from baseline to 9 months	No
Secondary	probing depth (mm)	measured in mm	Change from baseline to 9 months	No
Secondary	clinical attachment level (mm)	measured in mm	Change from baseline to 9 months	No
Secondary	gingival marginal level (mm)	measured in mm	Change from baseline to 9 months	No
Secondary	modified sulcus bleeding index	scale from 0-3	Change from baseline to 9 months	No
Secondary	plaque index	scale from 0-3	Change from baseline to 9 months	No