Advanced Platelet Rich Fibrin in Periodontal Angular Defects

Not Applicable

• Conditions: Intrabony Periodontal Defect
• Interventions: Procedure: Biphasic alloplast mixed with saline; Procedure: Advanced platelet-rich fibrin mixed with biphasic alloplast

• Registration Number: NCT03433066
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Study Start: 2018-03-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-03
• Last Update Posted: 2019-02-05
• Primary Completion: 2019-03
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (control)	Biphasic alloplast mixed with saline	Biphasic alloplast mixed with saline
group I (Test)	Advanced platelet-rich fibrin mixed with biphasic alloplast	Advanced platelet-rich fibrin mixed with biphasic alloplast

Primary Outcome Measures

Name	Time	Method
Clinical attachment level change	Baseline , 3 and 6 months posoperatively	The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline , 3 and 6 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Radiographic bone density	Baseline and 6 months postoperatively	Measuring the bone density before and after the procedure using CBCT
Radiographic bone fill	Baseline and 6 months postoperatively	The actual bone formation in the intrabony defect measured on a CBCT in comparison to the baseline CBCT
Probing depth change:	Baseline , 3 and 6 months postoperatively	The distance from the gingival margin to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively

Trial Locations

Locations (1)

Periodontology department, Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt