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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bony Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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OFD alone

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

Group Type PLACEBO_COMPARATOR

OFD alone

Intervention Type PROCEDURE

Periodontal surgical cleaning procedure

PRF + OFD

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

Group Type ACTIVE_COMPARATOR

OFD alone

Intervention Type PROCEDURE

Periodontal surgical cleaning procedure

Platelet rich Fibrin

Intervention Type DRUG

Natural platelet concentrate rich in growth factors

Bone + OFD

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

Group Type ACTIVE_COMPARATOR

OFD alone

Intervention Type PROCEDURE

Periodontal surgical cleaning procedure

Nanohydroxyapatite

Intervention Type DRUG

Synthetic bone graft

PRF + Bone + OFD

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

Group Type ACTIVE_COMPARATOR

OFD alone

Intervention Type PROCEDURE

Periodontal surgical cleaning procedure

Platelet rich Fibrin

Intervention Type DRUG

Natural platelet concentrate rich in growth factors

Nanohydroxyapatite

Intervention Type DRUG

Synthetic bone graft

Interventions

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OFD alone

Periodontal surgical cleaning procedure

Intervention Type PROCEDURE

Platelet rich Fibrin

Natural platelet concentrate rich in growth factors

Intervention Type DRUG

Nanohydroxyapatite

Synthetic bone graft

Intervention Type DRUG

Other Intervention Names

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Periodontal Surgery Natural growth factor Bone graft

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes