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

June 11, 2026 updated by: Mariusz Szuta, Jagiellonian University
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 allogenic dentin-derived 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolska
      • Krakow, Malopolska, Poland, 31-155
        • Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Impacted third molar extraction with associated dentigerous cyst enucleation- blood clot healing
Surgical extraction of impacted mandibular third molars combines with enucleation of associated dentigerous cysts performed under standarized clinical conditions.
Experimental: 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.
Procedure: Impacted third molar extraction with associated dentigerous cyst enucleation- regeneration with Advanced Platelet Rich Fibrin
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.
Experimental: 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.
Procedure: Impacted third molar extraction with associated dentigerous cyst enucleation- regeneration with Advanced Platelet Rich Fibrin and Autogenous Demineralized Dentin Matrix
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone regeneration
Time Frame: 6 and 12 months postoperatively
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.
6 and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
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.
Day of surgery, posteoperative day 2 and 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.75.2023
  • UJC/W41/NO/28.58 (Other Grant/Funding Number: University statutory funds)
  • UJC/W41/NO/28.40 (Other Grant/Funding Number: University statutory funds)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data sharing has not yet been determinaned. Data availability will be evaluated in accordance with institutional policies, ethical considerations, and patient confidentiality requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bone Regeneration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe