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| Name | Class |
|---|---|
| Wroclaw Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular Third Molar Extraction With Primary Wound Closure | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 4 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Swelling | Facial swelling assessed using standardized clinical measurements. | 1 day, 3 days, and 7 days after surgery |
| Postoperative Trismus | Maximum mouth opening assessed by measuring interincisal distance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medyczne Centrum Innowacji Wrocław Sp. z o.o. | Wroclaw | Poland |
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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Participants were randomly assigned to one of six parallel intervention groups and received only the intervention allocated to their study arm.
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Participants were not informed about the type of regenerative intervention applied. Due to the nature of the surgical procedures, care providers and investigators were not masked.
| 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. |
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| 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. |
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| Autologous Platelet Concentrates | Biological | 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. |
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| Photobiomodulation | Other | 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. |
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| 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. | 7 days after surgery |
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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