Healing of Intrabony Defects Following Treatment With PRF or EMD

NCT07183631 | Completed Phase 4

• 1 other identifier: PRF_EMD periodontal defect
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Probing pocket depth (PPD)

  preop and after 6 months

Secondary Outcomes (2)

• Gingival recession

  preop and after 6 months

• Clinical attachment loss

  preop and after 6 months

Study Arms (2)

Platelet-rich fibrin

EXPERIMENTAL

Other: Platelet rich fibrin

Enamel matrix derivate

SHAM COMPARATOR

Other: Enamel matrix derivate

Interventions

Platelet rich fibrin 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).

Platelet-rich fibrin

Enamel matrix derivate 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.

Enamel matrix derivate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No systemic conditions affecting treatment outcomes
• Good oral hygiene \[plaque index (PI) \<1; Löe 1967\]
• Compliance with the maintenance program
• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, 1088, Hungary

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Periodontal Diseases

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 19, 2025
• Study Start: September 1, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 25, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)