Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.

NCT07652216 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-06-23

No results posted yet for this study

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.

Conditions

  • Impact Molar
  • Mandible Cyst
  • Bone Regeneration
  • Platelet Rich Fibrin
  • Dentigerous Cyst
  • Dentin Matrix
  • Autogenous Dentin Graft
  • Demineralized Dentin Matrix
  • Impacted Lower Third Molar
  • Impacted Mandibular Third Molar

Interventions

PROCEDURE

Impacted third molar extraction

Surgical extraction of impacted mandibular third molar performed under standarized clinical conditions

BIOLOGICAL

Advanced Platelet-Rich Fibrin (A-PRF)

Application of autologous Advanced Platelet-Rich Fibrin (A-PRF) into the postoperative defect to support regenerative healing

PROCEDURE

Mandibular dentigerous cyst enucleation

Complete surgical enucleation of the mandibular dentigerous cyst associated with the impacted mandibular third molar

BIOLOGICAL

Autogenous Demineralized Dentin Matrix (ADDM)

Application of Autogenous Demineralized Dentin Matrix prepared from extracted tooth material to support bone regeneration

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Mariusz Szuta, MD, PhD · Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College

  • Tomasz Kaczmarzyk · Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-04
Primary Completion
2026-12-01
Completion
2027-04-01

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07652216 on ClinicalTrials.gov