Comparison of the Results of Biostimulation Treatment of Inferior Alveolar Nerve Injury Using Nd:YAG and Diode Lasers With Different Wavelengths.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Subjective Sensory Perception Measured by Visual Analog Scale (VAS)
研究概览
简要总结
Intraoral surgical procedures such as sagittal split osteotomy, dental implant placement, and surgical extraction of third molars are widely performed interventions in oral and maxillofacial surgery. Although these operations are generally safe and predictable, they may cause direct or indirect injury to the inferior alveolar nerve, one of the main sensory nerves of the mandible responsible for the innervation of the lower teeth, alveolar bone, gingiva, lower lip, and chin. Damage to this nerve can occur due to mechanical trauma, compression, thermal injury, or stretching during surgery, as well as following facial or mandibular trauma. As a consequence, patients may experience various neurosensory disturbances such as anesthesia, hypoesthesia, paresthesia, or dysesthesia. These conditions often result in discomfort, reduced functional capacity, and psychological distress, affecting both esthetic and functional expectations after surgical recovery. Restoring normal nerve function in such cases remains a major clinical challenge in oral surgery and neuromodulation research.
The inferior alveolar nerve follows a delicate anatomical path through the mandibular canal, where it is easily affected by surgical manipulations. Even minor trauma may lead to transient or permanent sensory dysfunction. The pathophysiology of such nerve injuries involves axonal degeneration, demyelination, and subsequent alterations in nerve conduction. Depending on the severity, nerve regeneration may occur spontaneously or may require therapeutic intervention. The degree of recovery depends on the extent of axonal disruption, the inflammatory response in the surrounding tissue, and the capacity of Schwann cells to facilitate remyelination. Traditional treatment approaches for inferior alveolar nerve injury include observation, pharmacological support, surgical decompression, or microsurgical repair. However, outcomes of these methods are often unpredictable, and recovery is slow. Therefore, noninvasive therapeutic modalities that can enhance neuronal healing and accelerate sensory recovery have become an area of increasing interest in modern dentistry and maxillofacial surgery.
Among these, the use of laser biostimulation-also known as low-level laser therapy or photobiomodulation-has gained significant attention as a noninvasive, safe, and clinically applicable method to promote nerve regeneration. Laser biostimulation involves the application of light energy at specific wavelengths to biological tissues, leading to a cascade of photochemical and photophysical effects at the cellular level. When absorbed by mitochondrial chromophores, particularly cytochrome c oxidase, the photons increase cellular metabolism, enhance ATP synthesis, stimulate DNA and RNA synthesis, and promote cellular proliferation and differentiation. In neural tissues, this process can lead to activation of Schwann cells, enhancement of neurotrophic factor secretion, reduction of oxidative stress, and modulation of inflammatory mediators, thereby creating a favorable microenvironment for axonal regrowth. Consequently, photobiomodulation represents an advanced therapeutic approach to accelerate neural healing following both iatrogenic and traumatic nerve injuries.
Two of the most commonly used laser types for biostimulation in clinical practice are diode and Nd:YAG lasers. Both operate in the near-infrared region of the electromagnetic spectrum but differ in wavelength, absorption characteristics, and depth of tissue penetration. The diode laser emits light typically between 800 and 1000 nanometers, with the 980-nanometer wavelength being one of the most widely used in dentistry. Its energy is well absorbed by melanin and hemoglobin, making it particularly effective in soft-tissue applications, wound healing, pain modulation, and superficial tissue regeneration. The Nd:YAG laser, operating at 1064 nanometers, has a longer wavelength that allows deeper tissue penetration. It is less absorbed by superficial pigments and more effective in reaching submucosal, muscular, and neural tissues. The differences in penetration depth and absorption profiles mean that while diode lasers are efficient for surface-level biostimulation, Nd:YAG lasers are more suited for stimulating deeper anatomical structures such as nerves and bone.
详细描述
Inferior alveolar nerve injury is one of the most challenging postoperative complications following intraoral surgical procedures and mandibular trauma. The inferior alveolar nerve, which provides sensory innervation to the lower teeth, alveolar bone, and lower lip, is highly susceptible to injury during surgical procedures such as sagittal split osteotomy, dental implant placement, and third molar extraction. Such injuries may lead to neurosensory disturbances, including anesthesia, hypoesthesia, and paresthesia, which significantly affect patients' quality of life, functional comfort, and esthetic satisfaction. Although some nerve injuries recover spontaneously, many cases require active therapeutic intervention to enhance nerve regeneration and restore normal sensory function. Conventional approaches, including pharmacological treatment and microsurgical repair, often have limited effectiveness. Therefore, photobiomodulation therapy has gained attention as a noninvasive, safe, and efficient method for promoting neural regeneration.
Photobiomodulation, also known as laser biostimulation or low-level laser therapy, involves the application of monochromatic light at specific wavelengths to biological tissues to stimulate cellular repair and regeneration without causing thermal damage. The absorbed light energy interacts with intracellular chromophores such as cytochrome c oxidase, leading to increased mitochondrial activity, ATP synthesis, and modulation of oxidative metabolism. This cascade enhances cellular proliferation, collagen synthesis, and growth factor release, ultimately supporting nerve tissue repair. In neural tissue, laser irradiation has been observed to stimulate Schwann cell proliferation, promote myelin regeneration, and accelerate axonal growth. Additionally, photobiomodulation exerts anti-inflammatory effects by reducing proinflammatory cytokine levels and modulating oxidative stress, creating an optimal environment for nerve healing.
Different laser systems have been used for biostimulation in clinical and experimental studies. Among them, diode and Nd:YAG lasers are two of the most commonly used devices, both emitting light in the near-infrared region but differing in wavelength, penetration depth, and absorption characteristics. The diode laser, operating at approximately 980 nm, is absorbed efficiently by melanin and hemoglobin and is highly effective in soft-tissue applications, wound healing, and superficial neuromodulation. The Nd:YAG laser, with a wavelength of 1064 nm, penetrates more deeply into biological tissues and can reach deeper neural structures. Its energy is less absorbed by superficial pigments, allowing stimulation of submucosal and perineural tissues. These physical and optical differences may influence their biological effects on injured neural tissue. While diode lasers may be advantageous for superficial applications and ease of use, Nd:YAG lasers may provide superior biostimulatory effects for deeper structures such as the inferior alveolar nerve.
This study has been designed to investigate and compare the therapeutic effects of Nd:YAG and diode laser biostimulation on inferior alveolar nerve injury resulting from intraoral surgical procedures and mandibular trauma. The hypothesis is that both laser systems will improve neurosensory recovery compared to natural healing, but the Nd:YAG laser may demonstrate superior efficacy due to its greater tissue penetration and direct interaction with deeper nerve structures.
A total of 30 participants aged 18 years or older with confirmed inferior alveolar nerve injury will be included. All participants will have experienced nerve damage following procedures such as sagittal split osteotomy, implant placement, or third molar extraction, or due to mandibular trauma. Individuals with systemic diseases affecting nerve healing, history of smoking, or previous laser therapy will be excluded. Participants will be randomly assigned into three equal groups: Group 1 will receive diode laser therapy, Group 2 will receive Nd:YAG laser therapy, and Group 3 will serve as a control group without laser treatment. Randomization will be performed using a sealed-envelope method to ensure allocation concealment, and both participants and evaluators will remain blinded to the treatment assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
This clinical study is designed as a single-blind, randomized, parallel assignment trial. The masking strategy in this study primarily applies to the participants, who remain unaware of the type of laser system used during the biostimulation sessions. Masking of participants is implemented to minimize subjective bias in sensory evaluation and to ensure that the perceived or expected benefits of laser therapy do not influence the outcome assessments. The overall goal of this masking approach is to enhance the internal validity of the study by maintaining participant neutrality and preventing placebo or expectation effects from altering the recorded data.
At the beginning of the study, all eligible participants are informed that they will receive either a laser treatment or a control procedure. However, they are not told whether the laser used is an Nd:YAG or a Diode laser. Both laser devices are similar in appearance and operation, producing comparable auditory and visual cues such as
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older.
- •Patients diagnosed with inferior alveolar nerve injury following intraoral surgical procedures (such as sagittal split osteotomy, implant placement, or third molar extraction) or mandibular trauma.
- •Presence of sensory disturbances including anesthesia, hypoesthesia, or paresthesia in the lower lip and chin region.
- •Ability and willingness to participate in the study and attend all scheduled follow-up visits.
- •Provision of written informed consent prior to participation.
排除标准
- •History of systemic diseases that may affect nerve healing (e.g., diabetes mellitus, neuropathies, autoimmune disorders).
- •Current use of medications known to interfere with nerve regeneration (e.g., corticosteroids, neurotoxic drugs).
- •Previous laser therapy or photobiomodulation treatment to the same area.
- •History of smoking or alcohol abuse.
- •Pregnant or breastfeeding women.
- •Patients with local infection, malignancy, or open wounds in the treatment area.
- •Inability to comply with study procedures or follow-up schedule.
研究组 & 干预措施
Control Group
Participants in this arm will not receive any active laser treatment. They will undergo the same evaluation schedule and follow-up intervals as the experimental groups. This control arm allows the comparison of natural neurosensory recovery with that achieved by Nd:YAG and Diode laser biostimulation therapies.
Nd:YAG Laser Group
Participants in this arm will receive Nd:YAG laser biostimulation therapy for inferior alveolar nerve injury. The laser operates at a wavelength of 1064 nm with parameters of 0.5 W power and 10 Hz frequency. The application will be performed intraorally and extraorally along the course of the injured nerve region twice per week for three consecutive weeks. Each session will last approximately two minutes. The purpose of this intervention is to evaluate the biostimulatory effect of Nd:YAG laser on neurosensory recovery following intraoral surgery or trauma.
干预措施: Nd:YAG Laser Biostimulation (Device)
Diode Laser Group
Participants in this arm will receive Diode laser biostimulation therapy for inferior alveolar nerve injury. The laser operates at a wavelength of 980 nm with parameters of 200 mW power, 10 Hz frequency, and 2 J energy per session. Applications will be performed intraorally and extraorally over the affected mandibular region twice per week for three consecutive weeks. Each session will last approximately two minutes. This arm aims to evaluate the effectiveness of Diode laser photobiomodulation on neural regeneration and sensory recovery.
干预措施: Diode Laser Biostimulation (Device)
结局指标
主要结局
Change in Subjective Sensory Perception Measured by Visual Analog Scale (VAS)
时间窗: Baseline (pre-treatment), immediately after completion of 3-week treatment, 1 month, 3 months, and 6 months post-treatment
This primary outcome assesses participants' subjective perception of numbness, paresthesia, or altered sensation in the lower lip and chin region. Participants will rate their sensory perception using a 10-point Visual Analog Scale (VAS), where 0 represents complete anesthesia (no sensation) and 10 represents normal sensation. Improvement will be defined as an increase in VAS score from baseline to follow-up time points.
次要结局
- Improvement in Neurosensory Function Measured by Two-Point Discrimination (2PD)(Baseline (pre-treatment), immediately after completion of 3-week treatment, 1 month, 3 months, and 6 months post-treatment)
研究者
Yaşar Tolga KAYIM
Doctor
Ondokuz Mayıs University
