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Active Not Recruiting
NCT07652216
Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
Conditions: Impact Molar, Mandible Cyst, Bone Regeneration, Platelet Rich Fibrin, Dentigerous Cyst, Dentin Matrix, Autogenous Dentin Graft, Demineralized Dentin Matrix, Impacted Lower Third Molar, Impacted Mandibular Third Molar
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: Jagiellonian University
Location: Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College Krakow Malopolska
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 Criteria
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
Source: ClinicalTrials.gov (NCT07652216). StuddyBuddy aggregates publicly available trial information.