Impact MolarCystregenNCT07652216
Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
A study testing Impacted third molar extraction, Advanced Platelet-Rich Fibrin (A-PRF) and Mandibular dentigerous cyst enucleation in people with Impact Molar and Mandible Cyst, run by Jagiellonian University at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Impact Molar, Mandible Cyst, Bone Regeneration
- What is being tested?
- Impacted third molar extraction, Advanced Platelet-Rich Fibrin (A-PRF) and Mandibular dentigerous cyst enucleation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePoland
- Study dates
- 4 Apr 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Use of medications affecting bone metabolism
- Heavy smoking
- Inability to comply with follow-up visits or postoperative recommendations
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
Krakow, Malopolska, 31-155
About this study
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.
Read the 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. 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.
- Conditions
- Impact Molar, Mandible Cyst, Bone Regeneration, Platelet Rich Fibrin, Dentigerous Cyst, Dentin Matrix
- Being tested
- Impacted third molar extraction, Advanced Platelet-Rich Fibrin (A-PRF), Mandibular dentigerous cyst enucleation, Autogenous Demineralized Dentin Matrix (ADDM)
- Keywords
- Autogenous demineralized dentin matrix, dentin matrix, dentigerous cyst, mandible cyst, Impacted molar, prf, a-prf, platelet rich fibrin, impacted lower third molar, bone regeneration, demineralized dentin matrix
- Medical subject headings
- Dentigerous Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impacted third molar extractionProcedure or surgery
Surgical extraction of impacted mandibular third molar performed under standarized clinical conditions
Advanced Platelet-Rich Fibrin (A-PRF)Biological
Also called A-PRF
Application of autologous Advanced Platelet-Rich Fibrin (A-PRF) into the postoperative defect to support regenerative healing
Mandibular dentigerous cyst enucleationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Blood Clot Healing | Active comparator | Healing of the postoperative defect following enucleation of mandibular dentigerous cyst associated with extraction of impacted mandibular third molar without additional regenerative biomaterials Receives: Procedure: Impacted third molar extraction; Procedure: Mandibular dentigerous cyst enucleation |
| A-PRF | Experimental | 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 Receives: Procedure: Impacted third molar extraction; Biological: Advanced Platelet-Rich Fibrin (A-PRF); Procedure: Mandibular dentigerous cyst enucleation |
| A-PRF + Autogenous Demineralized Dentin Matrix | Experimental | Application 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 Receives: Procedure: Impacted third molar extraction; Biological: Advanced Platelet-Rich Fibrin (A-PRF); Procedure: Mandibular dentigerous cyst enucleation; Biological: Autogenous Demineralized Dentin Matrix (ADDM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 and 12 months postoperatively
Secondary outcomes (1)
Postoperative pain score measured using the Numerical Rating Scale (NRS)
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
Measured: Day of surgery, posteoperative day 2 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start4 Apr 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact MolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in parallel to one of three study groups following enucleation of mandibular dentigerous cysts associated with impacted mandibular third molars. Group A underwent healing on a natural blood clot, Group B received Advanced Platelet-Rich Fibrin (A-PRF), and Group C received A-PRF combined with Autogenous Demineralized Dentin Matrix. Postoperative pain intensity was assessed at predefined postoperative time points using a Numerical Rating Scale (NRS) with graphical visualisation.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Szuta, Jagiellonian University
- Investigators
- Mariusz Szuta, MD, PhD, Principal investigator, Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical CollegeTomasz Kaczmarzyk, Principal investigator, Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652216
- Sponsor's protocol ID
- 1072.6120.75.2023
- Other IDs
- UJC/W41/NO/28.58, UJC/W41/NO/28.40
- Acronym
- Cystregen
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
- ClinicalTrials.gov ID
- NCT07652216
- Acronym / sponsor ID
- Cystregen / 1072.6120.75.2023
- Conditions
- Impact Molar, Mandible Cyst, Bone Regeneration, Platelet Rich Fibrin, Dentigerous Cyst, Dentin Matrix
- Keywords
- Autogenous demineralized dentin matrix, dentin matrix, dentigerous cyst, mandible cyst, Impacted molar, prf, a-prf, platelet rich fibrin
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned in parallel to one of three study groups following enucleation of mandibular dentigerous cysts associated with impacted mandibular third molars. Group A underwent healing on a natural blood clot, Group B received Advanced Platelet-Rich Fibrin (A-PRF), and Group C received A-PRF combined with Autogenous Demineralized Dentin Matrix. Postoperative pain intensity was assessed at predefined postoperative time points using a Numerical Rating Scale (NRS) with graphical visualisation.
| Arm | Type | Receives |
|---|---|---|
| Blood Clot Healing | Active comparator | Procedure: Impacted third molar extraction, Procedure: Mandibular dentigerous cyst enucleationHealing of the postoperative defect following enucleation of mandibular dentigerous cyst associated with extraction of impacted mandibular third molar without additional regenerative biomaterials |
| A-PRF | Experimental | Procedure: Impacted third molar extraction, Biological: Advanced Platelet-Rich Fibrin (A-PRF), Procedure: Mandibular dentigerous cyst enucleationApplication 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 | Experimental | Procedure: Impacted third molar extraction, Biological: Advanced Platelet-Rich Fibrin (A-PRF), Procedure: Mandibular dentigerous cyst enucleation, Biological: Autogenous Demineralized Dentin Matrix (ADDM)Application 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impacted third molar extractionSurgical extraction of impacted mandibular third molar performed under standarized clinical conditions | Procedure or surgery | A-PRF, A-PRF + Autogenous Demineralized Dentin Matrix, Blood Clot Healing |
| Advanced Platelet-Rich Fibrin (A-PRF)Also: A-PRFApplication of autologous Advanced Platelet-Rich Fibrin (A-PRF) into the postoperative defect to support regenerative healing | Biological | A-PRF, A-PRF + Autogenous Demineralized Dentin Matrix |
| Mandibular dentigerous cyst enucleationComplete surgical enucleation of the mandibular dentigerous cyst associated with the impacted mandibular third molar | Procedure or surgery | A-PRF, A-PRF + Autogenous Demineralized Dentin Matrix, Blood Clot Healing |
| Autogenous Demineralized Dentin Matrix (ADDM)Application of Autogenous Demineralized Dentin Matrix prepared from extracted tooth material to support bone regeneration | Biological | A-PRF + Autogenous Demineralized Dentin Matrix |
Primary outcome
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
1 secondary outcome
Postoperative pain score measured using the Numerical Rating Scale (NRS)
Time frame: Day of surgery, posteoperative day 2 and 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariusz Szuta, MD, PhD principal investigator
Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
Tomasz Kaczmarzyk principal investigator
Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impacted third molar extraction, Advanced Platelet-Rich Fibrin (A-PRF) and Mandibular dentigerous cyst enucleation in people with Impact Molar and Mandible Cyst, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in bone defect volume assessed by CBCT (time frame: 6 and 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.