Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Platelet Rich Fibrin- PRF. (Cystregen)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
- Procedura: Impacted third molar extraction with associated dentigerous cyst enucleation- blood clot healing
- Procedura: Impacted third molar extraction with associated dentigerous cyst enucleation- regeneration with Advanced Platelet Rich Fibrin
- Procedura: Impacted third molar extraction with associated dentigerous cyst enucleation- regeneration with Advanced Platelet Rich Fibrin and Autogenous Demineralized Dentin Matrix
Descrizione dettagliata
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. Allogenic dentin-derived 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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Malopolska
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Krakow, Malopolska, Polonia, 31-155
- Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Blood Clot Healing
Healing of the postoperative defect following enucleation of mandibular dentigerous cyst associated with extraction of impacted mandibular third molar without additional regenerative biomaterials.
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Surgical extraction of impacted mandibular third molars combines with enucleation of associated dentigerous cysts performed under standarized clinical conditions.
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Sperimentale: A-PRF
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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Application of autologous advanced platelet rich fibrin (A-PRF) into the postoperative defect following enucleation of mandibular dentigerous cyst and extraction of associated impacted third molar to support regenerative healing.
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Sperimentale: A-PRF + Autogenous Demineralized Dentin Matrix
Application of advanced patelet rich fibrin (A-PRF) combined with autogenous demineralized dentin matrix (ADDM) into the postoperative defect following enucleation of mandibular dentigerous cyst associated with enucleation of impacted mandibular third molars.
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Application of autologous advanced platelet rich fibrin (A-PRF) and antogenous demineralized dentin matrix (ADDM) into the postoperative defect following enucleation of mandibular dentigerous cyst and extraction of associated impacted third molar to support regenerative healing.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Bone regeneration
Lasso di tempo: 6 and 12 months postoperatively
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Cone- beam computed tomography (CBCT) assessment of bone healing following enucleation of mandibular dentigerous cysts associated with impacted mandibular third molars treated with different regenerative approaches.
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6 and 12 months postoperatively
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Postoperative Pain Intensity
Lasso di tempo: Day of surgery, posteoperative day 2 and 6.
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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.
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Day of surgery, posteoperative day 2 and 6.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mariusz Szuta, MD, PhD, Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
- Investigatore principale: Tomasz Kaczmarzyk, Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
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Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1072.6120.75.2023
- UJC/W41/NO/28.58 (Altro numero di sovvenzione/finanziamento: University statutory funds)
- UJC/W41/NO/28.40 (Altro numero di sovvenzione/finanziamento: University statutory funds)
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