Medyczne Centrum Innowacji Wrocław Sp. z o.o.
Wroclaw, Poland
NCT Number: NCT07324213
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.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Wroclaw, Poland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Other names: Advanced Platelet-Rich Fibrin (A-PRF+), Concentrated Growth Factors (CGF)
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.
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.
Time frame: 4 months after surgery
Bone regeneration within the post-extraction socket assessed using cone-beam computed tomography-based fractal dimension analysis.
Time frame: 1 day, 3 days, and 7 days after surgery
Facial swelling assessed using standardized clinical measurements.
Time frame: 1 day, 3 days, and 7 days after surgery
Maximum mouth opening assessed by measuring interincisal distance.
Time frame: 7 days after surgery
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.
Medical Innovation Center Wroclaw
Other
Evaluation of the Degree of Regeneration of Post-Extraction Alveolar Sockets of Mandibular Third Molars Using Tissue Engineering and Photobiomodulation
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