Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
Cystregen
3 other identifiers
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2024
CompletedFirst Submitted
Initial submission to the registry
June 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
June 23, 2026
June 1, 2026
2.7 years
June 11, 2026
June 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Postoperative pain score measured using the Numerical Rating Scale (NRS)
Day of surgery, posteoperative day 2 and 6
Study Arms (3)
Blood Clot Healing
ACTIVE COMPARATORHealing of the postoperative defect following enucleation of mandibular dentigerous cyst associated with extraction of impacted mandibular third molar without additional regenerative biomaterials
A-PRF
EXPERIMENTALApplication 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
A-PRF + Autogenous Demineralized Dentin Matrix
EXPERIMENTALApplication 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
Krakow, Malopolska, 31-155, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 11, 2026
First Posted
June 17, 2026
Study Start
April 4, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
June 23, 2026
Record last verified: 2026-06