Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Platelet Rich Fibrin- PRF. (Cystregen)
Studieoversigt
Status
Betingelser
Intervention / Behandling
- Procedure: Impacted third molar extraction with associated dentigerous cyst enucleation- blood clot healing
- Procedure: Impacted third molar extraction with associated dentigerous cyst enucleation- regeneration with Advanced Platelet Rich Fibrin
- Procedure: Impacted third molar extraction with associated dentigerous cyst enucleation- regeneration with Advanced Platelet Rich Fibrin and Autogenous Demineralized Dentin Matrix
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Malopolska
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Krakow, Malopolska, Polen, 31-155
- Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Bone regeneration
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain Intensity
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mariusz Szuta, MD, PhD, Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
- Ledende efterforsker: Tomasz Kaczmarzyk, Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1072.6120.75.2023
- UJC/W41/NO/28.58 (Andet bevillings-/finansieringsnummer: University statutory funds)
- UJC/W41/NO/28.40 (Andet bevillings-/finansieringsnummer: University statutory funds)
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