Evaluation of Platelets Rich Fibrin and Nanohydroxyapatite in the Treatment of Intrabony Defects

King Abdulaziz University

Status and phase: Completed; Early Phase 1

Conditions: Bony Defects

Treatments: Drug: Nanohydroxyapatite; Drug: Platelet rich Fibrin; Procedure: OFD alone

Study type: Interventional

Funder types: Other

Identifiers

NCT02810548

032-16

Details and patient eligibility

About

Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in osseous regeneration in the areas of periodontal surgery.

Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in periodontal intrabony defects.

Full description

Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. The regenerative and wound healing potential of platelets has attracted much attention over the last few years. Researches had demonstrated the benefits of platelet concentrates in osseous regeneration in the areas of periodontal surgery and implantology. In addition, nanohydroxyapatite was shown to be unsheathed by newly formed bone and partly replaced by it, but resorbed very slowly, as shown in animal experiments after 9 months or in clinical studies after a 6-month observation period. The clinical and biochemical studies evaluating the regenerative effect of PRF alone or in combination with nanohydroxyapatite in periodontal intrabony defects are still deficient.

Aim of the study: to evaluate clinical and biochemical effect of PRF with/without nanohydroxyapatite in treatment of human intrabony defects.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All patients are free from systemic illness.
• All patients should be diagnosed as having chronic periodontitis.
• Patients should be cooperative, motivated and willing to follow our treatment protocol and follow up visits.
• Patients selected had not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.

Exclusion criteria

• Presence of areas of periodontal pocket of (probing depth ≥5 and clinical attachment level (CAL) ≥ 3).
• Patients who have received any type of periodontal treatment in the past 6 months prior to examination.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

OFD alone

Placebo Comparator group

Description:

Control group: including 15 defects that will receive open flap debridement (OFD).

Treatment:

Procedure: OFD alone

PRF + OFD

Active Comparator group

Description:

Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD).

Treatment:

Procedure: OFD alone

Drug: Platelet rich Fibrin

Bone + OFD

Active Comparator group

Description:

Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD).

Treatment:

Procedure: OFD alone

Drug: Nanohydroxyapatite

PRF + Bone + OFD

Active Comparator group

Description:

Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD).

Treatment:

Procedure: OFD alone

Drug: Platelet rich Fibrin

Drug: Nanohydroxyapatite