Healing of Intrabony Defects Following Treatment With PRF or EMD

NCT ID: NCT07183631

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2025-08-25

Brief Summary

Objective: To evaluate clinically the long-term results following treatment of deep intrabony defects with either platelet-rich fibrin gel (PRF) or an enamel matrix derivative (EMD).

Methods: Twenty six patients diagnosed with advanced chronic periodontitis, and each of whom displaying one deep intrabony defect were randomly treated with open flap debridement and with either PRF (test) or EMD (Emdogain, Straumann, Basel, Switzerland) (control). The clinical outcomes were evaluated at baseline, at six months and three years after treatment. The primary outcome variable was the clinical attachment level (CAL).

Conditions

Periodontal Bone Loss; Periodontal Disease; Platelet Rich Fibrin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platelet-rich fibrin

Group Type: EXPERIMENTAL

Platelet rich fibrin

Intervention Type: OTHER

Platelet-rich fibrin (PRF) was prepared according to the manufacturer's instructions. A blood sample was collected from the cubital vein in 10 ml tubes without anticoagulant and centrifuged at 3000 rpm for 10 minutes using a GLO GT416 table centrifuge (GLO Glotech Co. Ltd, Korea) and GLO PRP collection kit (GLO PRP-Kit, Glotech Co, Asan Choong-nam, Korea/ Glofinn, Finland).

Enamel matrix derivate

Group Type: SHAM_COMPARATOR

Enamel matrix derivate

Intervention Type: OTHER

In the control group, the root surface was conditioned with 24% ethylenediaminetetraacetic acid (EDTA) gel for two minutes, washed with physiological saline solution, dried, and treated with enamel matrix derivative (EMD), ("Emdogain", Straumann, Switzerland) per manufacturer recommendations.

Interventions

Platelet rich fibrin

Platelet-rich fibrin (PRF) was prepared according to the manufacturer's instructions. A blood sample was collected from the cubital vein in 10 ml tubes without anticoagulant and centrifuged at 3000 rpm for 10 minutes using a GLO GT416 table centrifuge (GLO Glotech Co. Ltd, Korea) and GLO PRP collection kit (GLO PRP-Kit, Glotech Co, Asan Choong-nam, Korea/ Glofinn, Finland).

Intervention Type: OTHER

Enamel matrix derivate

In the control group, the root surface was conditioned with 24% ethylenediaminetetraacetic acid (EDTA) gel for two minutes, washed with physiological saline solution, dried, and treated with enamel matrix derivative (EMD), ("Emdogain", Straumann, Switzerland) per manufacturer recommendations.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. No systemic conditions affecting treatment outcomes

2. Good oral hygiene [plaque index (PI) <1; Löe 1967]

3. Compliance with the maintenance program

4. Presence of at least one intra-bony defect with a probing depth (PD) of ≥6 mm and an intra-bony component of ≥3 mm confirmed by radiographs.

Exclusion Criteria

• significant medical conditions: irradiation in the maxillofacial area, uncontrolled diabetes or hypertension, systemic steroid or bisphosphonate treatment, pregnancy, or lactation, infectious diseases,
• age <18 years, (3) smokers (>5 cigarettes/day),
• high residual inflammation (FMBS >25%),
• poor oral hygiene (FMPS >25%), and
• defect-related factors: furcation involvement, endo-perio defects, horizontal defects, or multi-tooth defects .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Eleonora Solyom

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Semmelweis University

Budapest, , Hungary

Countries

Hungary

Other Identifiers

PRF_EMD periodontal defect

Identifier Type: -

Identifier Source: org_study_id