Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
Krakow, Malopolska, 31-155, Poland
NCT Number: NCT07652216
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.
This study is active but is not currently recruiting participants.
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Interventional
Not applicable
Krakow, Malopolska, 31-155, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical extraction of impacted mandibular third molar performed under standarized clinical conditions
Application of autologous Advanced Platelet-Rich Fibrin (A-PRF) into the postoperative defect to support regenerative healing
Other names: A-PRF
Complete surgical enucleation of the mandibular dentigerous cyst associated with the impacted mandibular third molar
Application of Autogenous Demineralized Dentin Matrix prepared from extracted tooth material to support bone regeneration
Time frame: 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
Time frame: 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
Jagiellonian University
Other
Acronym: Cystregen
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