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

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Periodontitis

Treatments: Procedure: Open flap debridement (OFD); Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate; Procedure: OFD with Platelet rich fibrin (PRF)

Study type: Interventional

Funder types: Other

Identifiers

NCT02518152

GDCRI/ACM/PG/PhD/2/2013-2014N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Group 1

Active Comparator group

Description:

Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating periodontal defect

Treatment:

Procedure: Open flap debridement (OFD)

Group 2

Active Comparator group

Description:

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating periodontal defect

Treatment:

Procedure: OFD with Platelet rich fibrin (PRF)

Group 3

Active Comparator group

Description:

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating periodontal defect

Treatment:

Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate