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Healing of Intrabony Defects Following Treatment With PRF or EMD

Evaluating Treatment of Intra-bony Defects With PRF or EMD

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07183631
Enrollment
28
Registered
2025-09-19
Start date
2021-09-01
Completion date
2025-08-25
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Bone Loss, Periodontal Disease, Platelet Rich Fibrin

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).

Interventions

OTHERPlatelet 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).

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.

Sponsors

Semmelweis University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frame
Probing pocket depth (PPD)preop and after 6 months

Secondary

MeasureTime frame
Gingival recessionpreop and after 6 months
Clinical attachment losspreop and after 6 months

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026