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| ID | Type | Description | Link |
|---|---|---|---|
| UJC/W41/NO/28.58 | Other Grant/Funding Number | University statutory funds | |
| UJC/W41/NO/28.40 | Other Grant/Funding Number | University statutory funds |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Clot Healing | Active Comparator | Healing of the postoperative defect following enucleation of mandibular dentigerous cyst associated with extraction of impacted mandibular third molar without additional regenerative biomaterials |
|
| A-PRF | Experimental | Application of Advanced Platelet-Rich Fibrin (A-PRF) into the postoperative defect following enucleation of mandibular dentigerous cyst associated with extraction of impacted mandibular third molar |
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| A-PRF + Autogenous Demineralized Dentin Matrix | Experimental | Application of Advanced Platelet-Rich Fibrin (A-PRF) combined with autogenous demineralized dentin matrix (ADDM) into the postoperative defect following enucleation of mandibular dentigerous cyst associated with extraction of impacted mandibular third molars |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impacted third molar extraction | Procedure | Surgical extraction of impacted mandibular third molar performed under standarized clinical conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in bone defect volume assessed by CBCT | 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 | 6 and 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score measured using the Numerical Rating Scale (NRS) | 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 | Day of surgery, posteoperative day 2 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariusz Szuta, MD, PhD | Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College | Principal Investigator |
| Tomasz Kaczmarzyk | Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College | Krakow | Malopolska | 31-155 | Poland |
Individual participant data sharing has not yet been determinaned. Data availability will be evaluated in accordance with institutional policies, ethical considerations, and patient confidentiality requirements.
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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.
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| Advanced Platelet-Rich Fibrin (A-PRF) | Biological | Application of autologous Advanced Platelet-Rich Fibrin (A-PRF) into the postoperative defect to support regenerative healing |
|
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| Mandibular dentigerous cyst enucleation | Procedure | Complete surgical enucleation of the mandibular dentigerous cyst associated with the impacted mandibular third molar |
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| Autogenous Demineralized Dentin Matrix (ADDM) | Biological | Application of Autogenous Demineralized Dentin Matrix prepared from extracted tooth material to support bone regeneration |
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| ID | Term |
|---|---|
| D003803 | Dentigerous Cyst |
| ID | Term |
|---|---|
| D009807 | Odontogenic Cysts |
| D007570 | Jaw Cysts |
| D001845 | Bone Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
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