Evaluation of the Degree of Regeneration of Post-Extraction Alveolar Sockets of Mandibular Third Molars Using Tissue Engineering and Photobiomodulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Alveolar Bone Regeneration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Presence of systemic diseases or metabolic disorders.
- •Pregnancy or breastfeeding.
- •Recent antibiotic therapy.
- •Poor oral hygiene.
- •Exceptionally difficult tooth position.
- •Surgical procedure exceeding the expected duration.
- •Inability to achieve primary wound closure.
- •Failure to comply with follow-up visits.
研究组 & 干预措施
Control - Standard Extraction
Participants underwent surgical extraction of an impacted mandibular third molar followed by standard primary wound closure without the use of platelet concentrates or photobiomodulation.
干预措施: Mandibular Third Molar Extraction With Primary Wound Closure (Procedure)
Photobiomodulation
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.
干预措施: Mandibular Third Molar Extraction With Primary Wound Closure (Procedure)
Photobiomodulation
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.
干预措施: Photobiomodulation (Other)
A-PRF+
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.
干预措施: Mandibular Third Molar Extraction With Primary Wound Closure (Procedure)
A-PRF+
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.
干预措施: Autologous Platelet Concentrates (Biological)
CGF
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.
干预措施: Mandibular Third Molar Extraction With Primary Wound Closure (Procedure)
CGF
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.
干预措施: Autologous Platelet Concentrates (Biological)
A-PRF+ Plus Photobiomodulation
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.
干预措施: Mandibular Third Molar Extraction With Primary Wound Closure (Procedure)
A-PRF+ Plus Photobiomodulation
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.
干预措施: Autologous Platelet Concentrates (Biological)
A-PRF+ Plus Photobiomodulation
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.
干预措施: Photobiomodulation (Other)
CGF Plus Photobiomodulation
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.
干预措施: Mandibular Third Molar Extraction With Primary Wound Closure (Procedure)
CGF Plus Photobiomodulation
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.
干预措施: Autologous Platelet Concentrates (Biological)
CGF Plus Photobiomodulation
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.
干预措施: Photobiomodulation (Other)
结局指标
主要结局
Alveolar Bone Regeneration
时间窗: 4 months after surgery
Bone regeneration within the post-extraction socket assessed using cone-beam computed tomography-based fractal dimension analysis.
Postoperative Pain Intensity
时间窗: 1 day, 3 days, and 7 days after surgery
Postoperative pain intensity assessed using a visual analogue scale (VAS, visual analogue scale 1-10).
次要结局
- Postoperative Swelling(1 day, 3 days, and 7 days after surgery)
- Postoperative Trismus(1 day, 3 days, and 7 days after surgery)
- Early Wound Healing(7 days after surgery)
研究者
Jakub Hadzik
Associate Professor, PhD, DSc (Med.), Specialist in Oral Surgery
Medical Innovation Center Wroclaw