Impacted Mandibular Third MolarNCT07324213
Healing of Mandibular Third Molar Extraction Sockets Using Platelet Concentrates and Photobiomodulation
A study testing Mandibular Third Molar Extraction With Primary Wound Closure, Autologous Platelet Concentrates and Photobiomodulation in people with Impacted Mandibular Third Molar and Alveolar Bone Loss, run by Medical Innovation Center Wroclaw at 1 site in Poland.
Trial summary
Surgical removal of impacted mandibular third molars is a common procedure that may be associated with postoperative pain, swelling, limited mouth opening, and delayed bone healing. Various regenerative techniques are used to improve healing outcomes after tooth extraction. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar, Alveolar Bone Loss, Impacted Mandibular Third Molar Extraction
- What is being tested?
- Mandibular Third Molar Extraction With Primary Wound Closure, Autologous Platelet Concentrates and Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2020to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 to 40 years.
- Indication for surgical extraction of a partially or fully impacted mandibular third molar.
- Generally healthy individuals without systemic diseases.
- Ability to provide written informed consent.
- Willingness to attend scheduled follow-up visits.
Who cannot join
- Presence of systemic diseases or metabolic disorders.
- Pregnancy or breastfeeding.
- Smoking.
- Recent antibiotic therapy.
- Poor oral hygiene.
- Exceptionally difficult tooth position.
Show all 9Show fewer
- Surgical procedure exceeding the expected duration.
- Inability to achieve primary wound closure.
- Failure to comply with follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Degree of Regeneration of Post-Extraction Alveolar Sockets of Mandibular Third Molars Using Tissue Engineering and Photobiomodulation
Surgical removal of impacted mandibular third molars is a common procedure that may be associated with postoperative pain, swelling, limited mouth opening, and delayed bone healing. Various regenerative techniques are used to improve healing outcomes after tooth extraction.
This study evaluated whether autologous platelet concentrates (advanced platelet-rich fibrin [A-PRF+] and concentrated growth factors [CGF]) and photobiomodulation using low-level laser therapy can improve healing after mandibular third molar extraction.
Read more
Participants requiring surgical removal of a mandibular third molar were randomly assigned to one of six treatment groups. Depending on the group, patients received standard wound closure alone, photobiomodulation, placement of autologous platelet concentrates into the extraction socket, or a combination of platelet concentrates and photobiomodulation.
Postoperative pain, swelling, mouth opening, and early wound healing were assessed during the first postoperative week. Bone regeneration within the extraction socket was evaluated using radiological imaging several months after surgery.
All procedures used in this study are commonly applied in clinical practice and are considered safe. The results of this study may help identify the most effective approach to improve healing and reduce postoperative discomfort following mandibular third molar extraction.
Read the detailed description
Surgical extraction of impacted mandibular third molars frequently results in postoperative complications such as pain, edema, trismus, and delayed bone regeneration. Advances in regenerative medicine have introduced autologous platelet concentrates, including advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF), which provide sustained release of growth factors that may enhance soft and hard tissue healing. Additionally, photobiomodulation using low-level laser therapy has been reported to reduce inflammation and stimulate tissue regeneration.
This single-center, randomized, single-blind clinical trial was conducted to evaluate the effectiveness of A-PRF+, CGF, and photobiomodulation, applied alone or in combination, in enhancing postoperative healing following mandibular third molar extraction.
A total of 122 generally healthy adult participants requiring surgical extraction of a partially or fully impacted mandibular third molar were enrolled. Participants were randomly allocated to one of six parallel study groups: standard extraction with primary wound closure (control), extraction with photobiomodulation, extraction with socket augmentation using A-PRF+, extraction with socket augmentation using CGF, extraction with A-PRF+ combined with photobiomodulation, or extraction with CGF combined with photobiomodulation. All surgical procedures were performed under standardized clinical conditions. Primary wound closure was attempted in all cases. Photobiomodulation was performed using a diode laser with a wavelength of 635 nm, power output of 100 mW, and energy density of 4 J/cm², applied at four points around the extraction socket. Autologous platelet concentrates were prepared from the patient's peripheral blood using standardized centrifugation protocols.
Clinical outcomes, including postoperative pain assessed using a visual analogue scale, facial swelling, mouth opening, and early wound healing, were evaluated at 1, 3, and 7 days after surgery. Radiological assessment of bone regeneration within the extraction socket was performed 3 to 4 months postoperatively using cone-beam computed tomography-based fractal dimension analysis.
The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All participants provided written informed consent prior to enrollment. The findings of this study aim to contribute to the optimization of postoperative management following mandibular third molar extraction by identifying effective regenerative treatment strategies.
- Conditions
- Impacted Mandibular Third Molar, Alveolar Bone Loss, Impacted Mandibular Third Molar Extraction
- Being tested
- Mandibular Third Molar Extraction With Primary Wound Closure, Autologous Platelet Concentrates, Photobiomodulation
- Keywords
- Mandibular third molar extraction,, Platelet-rich fibrin,, Concentrated growth factors,, Fractal dimension analysis, Low-level laser therapy,, Photobiomodulation,, Bone regeneration,
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Third Molar Extraction With Primary Wound ClosureProcedure or surgery
Surgical extraction of a partially or fully impacted mandibular third molar performed under standardized clinical conditions, followed by primary wound closure with sutures. This procedure was applied in all study arms.
Autologous Platelet ConcentratesBiological
Also called Advanced Platelet-Rich Fibrin (A-PRF+), Concentrated Growth Factors (CGF)
Autologous platelet concentrates prepared from the participant's peripheral blood and placed into the extraction socket prior to primary wound closure. Advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF) were obtained using standardized centrifugation protocols and used according to the allocated study arm.
PhotobiomodulationOther
Adjunctive photobiomodulation performed using low-level laser therapy applied to the extraction site. The intervention was delivered immediately after surgery and during follow-up visits according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard Extraction | Other | Participants underwent surgical extraction of an impacted mandibular third molar followed by standard primary wound closure without the use of platelet concentrates or photobiomodulation. Receives: Procedure: Mandibular Third Molar Extraction With Primary Wound Closure |
| Photobiomodulation | Other | Participants underwent surgical extraction of an impacted mandibular third molar followed by primary wound closure and photobiomodulation using low-level laser therapy applied immediately after surgery and during follow-up visits. Receives: Procedure: Mandibular Third Molar Extraction With Primary Wound Closure; Other: Photobiomodulation |
| A-PRF+ | Other | Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous advanced platelet-rich fibrin (A-PRF+) into the extraction socket prior to primary wound closure. Receives: Procedure: Mandibular Third Molar Extraction With Primary Wound Closure; Biological: Autologous Platelet Concentrates |
| CGF | Other | Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous concentrated growth factors (CGF) into the extraction socket prior to primary wound closure. Receives: Procedure: Mandibular Third Molar Extraction With Primary Wound Closure; Biological: Autologous Platelet Concentrates |
| A-PRF+ Plus Photobiomodulation | Other | Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous advanced platelet-rich fibrin (A-PRF+) into the extraction socket and adjunctive photobiomodulation using low-level laser therapy. Receives: Procedure: Mandibular Third Molar Extraction With Primary Wound Closure; Biological: Autologous Platelet Concentrates; Other: Photobiomodulation |
| CGF Plus Photobiomodulation | Other | Participants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous concentrated growth factors (CGF) into the extraction socket and adjunctive photobiomodulation using low-level laser therapy. Receives: Procedure: Mandibular Third Molar Extraction With Primary Wound Closure; Biological: Autologous Platelet Concentrates; Other: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity was assessed using a visual analogue scale (VAS) ranging from 1 to 10, where 1 indicates no pain and 10 indicates the worst pain imaginable.
Measured: 1 day, 3 days, and 7 days after surgery
Alveolar Bone Regeneration
Bone regeneration within the post-extraction socket assessed using cone-beam computed tomography-based fractal dimension analysis.
Measured: 4 months after surgery
Secondary outcomes (3)
Postoperative Swelling
Facial swelling assessed using standardized clinical measurements.
Measured: 1 day, 3 days, and 7 days after surgery
Postoperative Trismus
Maximum mouth opening assessed by measuring interincisal distance.
Measured: 1 day, 3 days, and 7 days after surgery
Early Wound Healing
Early soft tissue healing was evaluated using the Early Healing Index (EHI), an ordinal scale with scores ranging from 1 (very poor soft tissue healing) to 5 (excellent soft tissue healing), with higher scores indicating a more favorable healing outcome.
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start2 Jan 2020
- Primary completion20 Dec 2023
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third 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 to one of six parallel intervention groups and received only the intervention allocated to their study arm.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Innovation Center Wroclaw
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Principal investigator, Jakub Hadzik, Medical Innovation Center Wroclaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324213
- Sponsor's protocol ID
- KB7052019-UMW
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and the need to protect participant privacy. Aggregated and anonymized results are reported in publications arising from this study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Degree of Regeneration of Post-Extraction Alveolar Sockets of Mandibular Third Molars Using Tissue Engineering and Photobiomodulation
- ClinicalTrials.gov ID
- NCT07324213
- Acronym / sponsor ID
- KB7052019-UMW
- Conditions
- Impacted Mandibular Third Molar, Alveolar Bone Loss, Impacted Mandibular Third Molar Extraction
- Keywords
- Mandibular third molar extraction,, Platelet-rich fibrin,, Concentrated growth factors,, Fractal dimension analysis, Low-level laser therapy,, Photobiomodulation,, Bone regeneration,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Medical Innovation Center WroclawUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 7 Jan 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.
Surgical removal of impacted mandibular third molars is a common procedure that may be associated with postoperative pain, swelling, limited mouth opening, and delayed bone healing. Various regenerative techniques are used to improve healing outcomes after tooth extraction.
This study evaluated whether autologous platelet concentrates (advanced platelet-rich fibrin [A-PRF+] and concentrated growth factors [CGF]) and photobiomodulation using low-level laser therapy can improve healing after mandibular third molar extraction.
Participants requiring surgical removal of a mandibular third molar were randomly assigned to one of six treatment groups. Depending on the group, patients received standard wound closure alone, photobiomodulation, placement of autologous platelet concentrates into the extraction socket, or a combination of platelet concentrates and photobiomodulation.
Postoperative pain, swelling, mouth opening, and early wound healing were assessed during the first postoperative week. Bone regeneration within the extraction socket was evaluated using radiological imaging several months after surgery.
All procedures used in this study are commonly applied in clinical practice and are considered safe. The results of this study may help identify the most effective approach to improve healing and reduce postoperative discomfort following mandibular third molar extraction.
Detailed description
Surgical extraction of impacted mandibular third molars frequently results in postoperative complications such as pain, edema, trismus, and delayed bone regeneration. Advances in regenerative medicine have introduced autologous platelet concentrates, including advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF), which provide sustained release of growth factors that may enhance soft and hard tissue healing. Additionally, photobiomodulation using low-level laser therapy has been reported to reduce inflammation and stimulate tissue regeneration.
This single-center, randomized, single-blind clinical trial was conducted to evaluate the effectiveness of A-PRF+, CGF, and photobiomodulation, applied alone or in combination, in enhancing postoperative healing following mandibular third molar extraction.
A total of 122 generally healthy adult participants requiring surgical extraction of a partially or fully impacted mandibular third molar were enrolled. Participants were randomly allocated to one of six parallel study groups: standard extraction with primary wound closure (control), extraction with photobiomodulation, extraction with socket augmentation using A-PRF+, extraction with socket augmentation using CGF, extraction with A-PRF+ combined with photobiomodulation, or extraction with CGF combined with photobiomodulation. All surgical procedures were performed under standardized clinical conditions. Primary wound closure was attempted in all cases. Photobiomodulation was performed using a diode laser with a wavelength of 635 nm, power output of 100 mW, and energy density of 4 J/cm², applied at four points around the extraction socket. Autologous platelet concentrates were prepared from the patient's peripheral blood using standardized centrifugation protocols.
Clinical outcomes, including postoperative pain assessed using a visual analogue scale, facial swelling, mouth opening, and early wound healing, were evaluated at 1, 3, and 7 days after surgery. Radiological assessment of bone regeneration within the extraction socket was performed 3 to 4 months postoperatively using cone-beam computed tomography-based fractal dimension analysis.
The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All participants provided written informed consent prior to enrollment. The findings of this study aim to contribute to the optimization of postoperative management following mandibular third molar extraction by identifying effective regenerative treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Participants were randomly assigned to one of six parallel intervention groups and received only the intervention allocated to their study arm.
| Arm | Type | Receives |
|---|---|---|
| Control - Standard Extraction | Other | Procedure: Mandibular Third Molar Extraction With Primary Wound ClosureParticipants underwent surgical extraction of an impacted mandibular third molar followed by standard primary wound closure without the use of platelet concentrates or photobiomodulation. |
| Photobiomodulation | Other | Procedure: Mandibular Third Molar Extraction With Primary Wound Closure, Other: PhotobiomodulationParticipants underwent surgical extraction of an impacted mandibular third molar followed by primary wound closure and photobiomodulation using low-level laser therapy applied immediately after surgery and during follow-up visits. |
| A-PRF+ | Other | Procedure: Mandibular Third Molar Extraction With Primary Wound Closure, Biological: Autologous Platelet ConcentratesParticipants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous advanced platelet-rich fibrin (A-PRF+) into the extraction socket prior to primary wound closure. |
| CGF | Other | Procedure: Mandibular Third Molar Extraction With Primary Wound Closure, Biological: Autologous Platelet ConcentratesParticipants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous concentrated growth factors (CGF) into the extraction socket prior to primary wound closure. |
| A-PRF+ Plus Photobiomodulation | Other | Procedure: Mandibular Third Molar Extraction With Primary Wound Closure, Biological: Autologous Platelet Concentrates, Other: PhotobiomodulationParticipants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous advanced platelet-rich fibrin (A-PRF+) into the extraction socket and adjunctive photobiomodulation using low-level laser therapy. |
| CGF Plus Photobiomodulation | Other | Procedure: Mandibular Third Molar Extraction With Primary Wound Closure, Biological: Autologous Platelet Concentrates, Other: PhotobiomodulationParticipants underwent surgical extraction of an impacted mandibular third molar followed by placement of autologous concentrated growth factors (CGF) into the extraction socket and adjunctive photobiomodulation using low-level laser therapy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 40 years.
- Indication for surgical extraction of a partially or fully impacted mandibular third molar.
- Generally healthy individuals without systemic diseases.
- Ability to provide written informed consent.
- Willingness to attend scheduled follow-up visits.
Key exclusion criteria (9 listed)
- Presence of systemic diseases or metabolic disorders.
- Pregnancy or breastfeeding.
- Smoking.
- Recent antibiotic therapy.
- Poor oral hygiene.
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 |
|---|---|---|
| Mandibular Third Molar Extraction With Primary Wound ClosureSurgical extraction of a partially or fully impacted mandibular third molar performed under standardized clinical conditions, followed by primary wound closure with sutures. This procedure was applied in all study arms. | Procedure or surgery | A-PRF+, A-PRF+ Plus Photobiomodulation, CGF, CGF Plus Photobiomodulation, Control - Standard Extraction, Photobiomodulation |
| Autologous Platelet ConcentratesAlso: Advanced Platelet-Rich Fibrin (A-PRF+), Concentrated Growth Factors (CGF)Autologous platelet concentrates prepared from the participant's peripheral blood and placed into the extraction socket prior to primary wound closure. Advanced platelet-rich fibrin (A-PRF+) and concentrated growth factors (CGF) were obtained using standardized centrifugation protocols and used according to the allocated study arm. | Biological | A-PRF+, A-PRF+ Plus Photobiomodulation, CGF, CGF Plus Photobiomodulation |
| PhotobiomodulationAdjunctive photobiomodulation performed using low-level laser therapy applied to the extraction site. The intervention was delivered immediately after surgery and during follow-up visits according to the study protocol. | Other | A-PRF+ Plus Photobiomodulation, CGF Plus Photobiomodulation, Photobiomodulation |
Primary outcome
Postoperative Pain Intensity
Time frame: 1 day, 3 days, and 7 days after surgery
Postoperative pain intensity was assessed using a visual analogue scale (VAS) ranging from 1 to 10, where 1 indicates no pain and 10 indicates the worst pain imaginable.
Alveolar Bone Regeneration
Time frame: 4 months after surgery
Bone regeneration within the post-extraction socket assessed using cone-beam computed tomography-based fractal dimension analysis.
3 secondary outcomes
Postoperative Swelling
Time frame: 1 day, 3 days, and 7 days after surgery
Postoperative Trismus
Time frame: 1 day, 3 days, and 7 days after surgery
Early Wound Healing
Time frame: 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and the need to protect participant privacy. Aggregated and anonymized results are reported in publications arising from this study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular Third Molar Extraction With Primary Wound Closure, Autologous Platelet Concentrates and Photobiomodulation in people with Impacted Mandibular Third Molar and Alveolar Bone Loss, run by Medical Innovation Center Wroclaw 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 5 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: finished, as of the sponsor's last update on 21 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Pain Intensity (time frame: 1 day, 3 days, and 7 days after surgery). The study lists 2 primary outcomes in all. 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 21 Jan 2026.