Advanced Platelet Rich Fibrin in Periodontal Angular 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

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-06-30

Brief Summary

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The aim of this study is to clinically and radiographically evaluate the efficacy of advanced platelet-rich fibrin (A-PRF) when used with biphasic alloplast in the management of intrabony defects in patients with moderate to severe chronic periodontitis.

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Detailed Description

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Biphasic alloplasts have been successfully used in management of intrabony defects. Advanced platelet-rich fibrin is believed to contain higher amount of growth factors and white blood cells than the well known PRF. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate the effect of the A-PRF. Therefore, a randomized controlled clinical trial was conducted to compare the healing of intrabony defects treated with A-PRF/biphasic alloplast combination and to those obtained with biphasic alloplast mixed with saline. Using a parallel arm design, 22 intrabony defects were randomly treated with either biphasic alloplast mixed with saline (control group) or with A-PRF/ biphasic alloplast combination (test group). The following clinical parameters were recorded at baseline, three and six months postoperatively : plaque index (PI), modified gingival index (MGI), probing depth (PD), clinical attachment level (CAL), while these radiographic measurements were recorded at baseline and six months postoperatively: bone fill and bone density.

Conditions

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Intrabony Periodontal Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This clinical study will be conducted on twenty-two (22) interproximal intrabony defects in patients with moderate to severe chronic periodontitis.These patients will be divided randomly into two groups:

* Group I: (test) will include eleven interproximal intrabony defects that will be treated with (Advanced platelet rich fibrin \& biphasic alloplast)
* Group II: (control) will include eleven interproximal intrabony defects that will be treated with (biphasic alloplast mixed with saline.)

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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group I (Test)

Advanced platelet-rich fibrin mixed with biphasic alloplast

Group Type EXPERIMENTAL

Advanced platelet-rich fibrin mixed with biphasic alloplast

Intervention Type PROCEDURE

mucoperiosteal flaps will be reflected to expose the defects , which will be debrided properly and finally filled with the freshly prepared Advanced platelet-rich fibrin mixed with the biphasic alloplast.

Group II (control)

Biphasic alloplast mixed with saline

Group Type ACTIVE_COMPARATOR

Biphasic alloplast mixed with saline

Intervention Type PROCEDURE

mucoperiosteal flap will be reflected to expose and clean the intrabony defect ,then it will be filled with biphasic alloplast mixed with saline.

Interventions

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Advanced platelet-rich fibrin mixed with biphasic alloplast

mucoperiosteal flaps will be reflected to expose the defects , which will be debrided properly and finally filled with the freshly prepared Advanced platelet-rich fibrin mixed with the biphasic alloplast.

Intervention Type PROCEDURE

Biphasic alloplast mixed with saline

mucoperiosteal flap will be reflected to expose and clean the intrabony defect ,then it will be filled with biphasic alloplast mixed with saline.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* They should be diagnosed as having moderate -severe chronic periodontitis according to the American Academy of Periodontology classification on gingival and periodontal diseases (1999)
* Clinical attachment loss (CAL) ,radiographic evidence of the presence of at least one intrabony defect.
* Patient's age between 25 to 55 years.
* Both sexes.
* No periodontal surgeries in the area of interest during the previous 6 months.
* The presence of intrabony defects (IBD) ≥3 mm deep (distance between alveolar crest and deepest point in the defect estimated from radiographs and confirmed upon surgical exposure).
* An interproximal probing depth (PD) ≥5 mm and clinical attachment loss (CAL) ≥3mm after phase I therapy in maxillary/ mandibular teeth.
* The presence of an adequate zone of keratinized gingiva at the facial aspect of the selected tooth.

Exclusion Criteria

* Patients who could not maintain O'leary plaque index (54) ≤10% after phase I therapy.
* Aggressive periodontitis patients.
* Patients with systemic conditions known to affect the periodontal status, or, under medications known to affect the outcomes of periodontal therapy.
* Pregnancy/lactation.
* Smoking and tobacco use in any form.
* Non vital teeth and teeth with grade III mobility.

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes