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NCT Number: NCT07652216

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College

Krakow, Malopolska, 31-155, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Impacted third molar extraction

Procedure

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

Advanced Platelet-Rich Fibrin (A-PRF)

Biological

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

Other names: A-PRF

Mandibular dentigerous cyst enucleation

Procedure

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

Autogenous Demineralized Dentin Matrix (ADDM)

Biological

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

Primary outcomes

  1. Reduction in bone defect volume assessed by CBCT

    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

Secondary outcomes

  1. Postoperative pain score measured using the Numerical Rating Scale (NRS)

    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

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Acronym: Cystregen

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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