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
Conditions
Keywords
Autogenous demineralized dentin matrix, dentin matrix, dentigerous cyst, mandible cyst, Impacted molar, prf, a-prf, platelet rich fibrin, impacted lower third molar, bone regeneration, demineralized dentin matrix
Brief 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.
Detailed description
Dentigerous cysts are among the most common odontogenic cysts and are frequently associated with impacted mandibular third molars. Surgical enucleation combined with impacted tooth extraction may result in postoperative bone defects and complications related to tissue healing. Various regenerative approaches have been proposed to improve postoperative healing and bone regeneration following cyst removal. Advanced Platelet-Rich Fibrin (A-PRF) is an autologous platelet concentrate rich in growth factors that may enhance soft and hard tissue healing. Autogenous Dentin Demineralized Matrix (ADDM) has been introduced as a biomaterial supporting bone regeneration and defect filling. However, limited evidence exists regarding their effectiveness following dentigerous cyst enucleation. This prospective clinical study compares three postoperative management protocols following dentigerous cyst enucleation associated with impacted mandibular third molar extraction: spontaneous blood clot healing, A-PRF application, and A-PRF combined with ADDM. The primary outcome measure is postoperative bone healing assessed during radiological follow-up. Secondary outcome measures include postoperative pain intensity evaluated using the Numerical Rating Scale (NRS) with graphical representation on the day of surgery and on the second and sixth postoperative day. The study aims to determine whether regenerative treatment with A-PRF or A-PRF combined with ADDM improves postoperative healing outcomes compared with spontaneous blood clot healing.
Interventions
PROCEDUREImpacted third molar extraction
Surgical extraction of impacted mandibular third molar performed under standarized clinical conditions
BIOLOGICALAdvanced Platelet-Rich Fibrin (A-PRF)
Application of autologous Advanced Platelet-Rich Fibrin (A-PRF) into the postoperative defect to support regenerative healing
PROCEDUREMandibular dentigerous cyst enucleation
Complete surgical enucleation of the mandibular dentigerous cyst associated with the impacted mandibular third molar
BIOLOGICALAutogenous Demineralized Dentin Matrix (ADDM)
Application of Autogenous Demineralized Dentin Matrix prepared from extracted tooth material to support bone regeneration
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned in parallel to one of three study groups following enucleation of mandibular dentigerous cysts associated with impacted mandibular third molars. Group A underwent healing on a natural blood clot, Group B received Advanced Platelet-Rich Fibrin (A-PRF), and Group C received A-PRF combined with Autogenous Demineralized Dentin Matrix. Postoperative pain intensity was assessed at predefined postoperative time points using a Numerical Rating Scale (NRS) with graphical visualisation.
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score measured using the Numerical Rating Scale (NRS) | Day of surgery, posteoperative day 2 and 6 | Assessment of postoperative pain intensity using the Numerical Rating Scale (NRS, 0-10) with graphic visualization following enucleation of mandibular dentigerous cyst with extraction of associated impacted third molar treated with different regenerative approaches |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORMariusz Szuta, MD, PhD
Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
PRINCIPAL_INVESTIGATORTomasz Kaczmarzyk
Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
Outcome results
None listed