Healing of Intrabony Defects Following Treatment With PRF or EMD

Not Applicable

Completed

• Conditions: Periodontal Bone Loss; Periodontal Disease; Platelet Rich Fibrin

• Registration Number: NCT07183631
• Lead Sponsor: Semmelweis University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-25
• Status Verified: 2025-09
• Study First Submitted: 2025-09-14
• Study First Submitted QC: 2025-09-14
• Last Update Submitted: 2025-09-14
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Probing pocket depth (PPD)	preop and after 6 months

Secondary Outcome Measures

Name	Time	Method
Gingival recession	preop and after 6 months
Clinical attachment loss	preop and after 6 months

Trial Locations

Locations (1)

Semmelweis University; 🇭🇺 Budapest, Hungary