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Clinical Trials in Poland / NCT07652216
Active, not recruiting Not applicable

Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.

NCT07652216 · tracked via the Priya Life Science Poland tracker
Sponsor
Jagiellonian University
Phase
Not applicable
Started
2024-04-04
Last updated
2026-06-23

Condition(s) studied

Impact MolarMandible CystBone RegenerationPlatelet Rich FibrinDentigerous CystDentin MatrixAutogenous Dentin GraftDemineralized Dentin MatrixImpacted Lower Third MolarImpacted Mandibular Third Molar

Investigational drug(s) / intervention(s)

Impacted third molar extractionAdvanced Platelet-Rich Fibrin (A-PRF)Mandibular dentigerous cyst enucleationAutogenous Demineralized Dentin Matrix (ADDM)

Impacted third molar extraction: Surgical extraction of impacted mandibular third molar performed under standarized clinical conditions

Advanced Platelet-Rich Fibrin (A-PRF): Application of autologous Advanced Platelet-Rich Fibrin (A-PRF) into the postoperative defect to support regenerative healing

Mandibular dentigerous cyst enucleation: Complete surgical enucleation of the mandibular dentigerous cyst associated with the impacted mandibular third molar

Autogenous Demineralized Dentin Matrix (ADDM): Application of Autogenous Demineralized Dentin Matrix prepared from extracted tooth material to support bone regeneration

Study summary

This prospective clinical study evaluates bone healing following dentigerous cyst enucleation associated with impacted mandibular third molar extraction. The study compares spontaneous blood clot healing, Advanced Platelet-Rich fibrin (A-PRF), and A-PRF combined with Autogenous Dentin Demineralized Matrix (ADDM). Bone healing is assessed as the primary outcome, while postoperative pain intensity assessed using the Numerical Rating Scale (NRS) with graphical representation represents a secondary outcome. The study aims to determine whether the use of A-PRF or A-PRF combined with ADDM improves postoperative healing outcomes compared with spontaneous blood clot healing.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients diagnosed with dentigerous cysts associated with impacted mandibular third molars * Indication for surgical enucleation and tooth extraction * Ability to provide informed consent * Availability for postoperative follow-up examinations and CBCT assessment Exclusion Criteria: * Acute local infection at the surgical site * Systemic diseases affecting bone healing or tissue regeneration * Immunosuppressive therapy * Pregnancy or breastfeeding * Hematological disorders affecting platelet function, coagulation, or fibrin formation (including thrombocytopenia, coagulopathies, or anticoagulant therapy). * History of radiotherapy in the head and neck region * Use of medications affecting bone metabolism * Heavy smoking * Inability to comply with follow-up visits or postoperative recommendations

Primary outcome measure(s)

  • Reduction in bone defect volume assessed by CBCT — 6 and 12 months postoperatively
    Evaluation of bone defect volume reduction using Cone-Beam Computed Tomography (CBCT) at 6 and 12 months following enucleation of mandibular dentigerous cysts associated with impacted mandibular third molars treated with different regenerative approaches

Trial sites (1)

FacilityCityRegionStatus
Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College Krakow Malopolska

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07652216 on ClinicalTrials.gov ↗ ← All trials in Poland