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NCT07453927
Background: The donor site (DS) in patients with severe burns is often associated with complications that may delay healing and negatively affect clinical outcomes. Impaired re-epithelialization, pain, inflammation, and risk of infection represent relevant challenges in burn care. Blue light (BL) photobiomodulation has demonstrated beneficial effects in different types of skin lesions, including modulation of inflammation and stimulation of tissue repair. Therefore, BL therapy may represent an innovative and non-invasive strategy to enhance DS healing and improve overall recovery. Methods: This protocol describes an interventional, controlled, prospective, single-center, post-market clinical study enrolling 25 patients with intermediate and deep burn injuries. A CE-marked device emitting BL will be used. Each participant will receive both treatments through an intra-patient controlled design: one DS area will be treated with Standard of Care (SoC) alone, while a second DS will receive SoC combined with BL therapy. This approach allows direct comparison of clinical outcomes within the same patient, minimizing inter-individual variability. The primary outcome is the comparison of DS healing time between areas treated with BL plus SoC and those treated with SoC alone. Secondary outcomes include assessment of wound bed characteristics using the Wound Bed Score (WBS), evaluation of pain intensity during the healing process through the Numeric Pain Rating Scale (NRS), and identification of clinical signs of infection by performing skin swabs on both treated and untreated areas. Safety will be assessed by monitoring local adverse reactions related to BL exposure, such as erythema, burning sensation, heat perception, skin irritation, or pruritus. Long-term scar quality will be evaluated at 1 and 3 months after complete healing using the Vancouver Scar Scale (VSS), allowing comparison of aesthetic and functional outcomes between the two treatment approaches. Follow-up visits at 1 and 3 months will also enable detection of late adverse events and confirmation of the persistence of therapeutic effects. Discussion/Conclusion: BL photobiomodulation appears to be a promising and well-tolerated adjunctive therapy for DS management in burn patients. This study aims to generate clinical evidence supporting its effectiveness and potential integration into routine burn care practice.
NCT07416006
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.
NCT07169357
This study consists of random patient selection and allocating them in 3 different groups. After being fit to be included according to the protocol's criteria and signing an informed consent, patients will be distributed after performing a dental surgery known as gingivectomy. Gingivectomy has been classified as the gold standard treatment option for the control of gingival enlargement. Wound recovery after gingivectomy and gingivoplasty occurs by secondary intention healing, thus post-surgical wounds can be strongly associated with discomfort, pain and delayed healing. For that reason, the first group will consist of 13 patients who will be exposed to hyaluronic acid gel or gingigel and photobiomodulation therapy to see if there is significant results in the post-operative healing phase. The second group will also consist of 13 patients who will undergo only photobiomodulation therapy. While the third group will have no clinical supportive care besides follow-up and analgesics upon request. All the values will be determined by using scores such as Visual analogue scale for pain, Landry's index for healing assessment and oral health quality of life, which consists of 14 questions to asses the enhancement of everyday problems affected by dental situations. Each case will be followed-up for 3 months post-operative.
NCT05989217
The present study was designed to evaluate different conservative therapies in patients with temporomandibular disorders. A total of 160 patients will be selected after the diagnosis of TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD), axis I. Patients will be randomly divided into five groups: OD group (n=32): treated with an occlusal device; LLLT group (n=32): treated with infrared low-level laser; ODL group (n=32): treated with OD + LLLT; LAT group (n=32): treated with laser acupuncture and ODLAT group (n=32): treated with both OD and LAT. Patients undergoing therapy with a stabilizing plate (made using the simplified technique) will be instructed to use the device every night while sleeping for four weeks. In both the LLLT and LAT groups, the protocol involved five applications: one at baseline, followed by four subsequent weekly sessions. The intensity of pain will be classified using the Visual Analog Scale (VAS). Mandible function will be assessed by maximum unassisted mouth opening. The impact of therapies on oral health will also be evaluated using the Oral Health Impact Profile (OHIP-14) instrument in a simplified form.
NCT05935306
The objective of this study will be to evaluate if photobiomodulation (FBM) can reduce postoperative pain in patients who will undergo endodontic surgery. For this randomized, controlled and double-blind clinical study, 34 patients without comorbidities who need endodontic surgery in the upper jaw (15 to 25 teeth) will be recruited. They will be randomly divided into an experimental group (n = 17) photobiomodulation (808nm, 100 mW, and 4J/cm2 with 5 points per vestibular). Applications will be made in the immediate postoperative period and 24 hours after surgery. Control group (n = 17) a FBM simulation will be performed in the same way as in the experimental group. In this group, the required analgesia will be administered within the standard with ibuprofen. Both groups will perform the necessary conventional procedures considered the gold standard in the literature. Both the patient and the evaluator will be blinded to the intervention performed. The primary outcome variable of the study will be postoperative pain, which will be assessed using the visual analog scale at all postoperative control visits (baseline, 24 hours and 7 days). As for the secondary outcome variables, the amount of systemic medication received according to the patient's need (will be provided by the investigator).. Radiographic images will be obtained after 1 and 2 months for evaluation of the repair (dimensions of the lesion, radiopacity). These radiographs will be taken digitally with the positioners implemented. Edema, ecchymosis, and evaluation of soft tissues in the anterior portion of the intra and extra-oral maxilla will also be evaluated. In addition, a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The X-rays will be taken in the 1st and 3rd month respectively.
NCT06866522
Photobiomodulation therapy (PBMT) is based on exposing biological tissues to low-intensity light, with effects depending on the light-tissue interaction. When irradiated without skin contact, part of the incident light is reflected and lost. In this context, the amount of reflected light in PBMT applied without skin contact, as well as the influence of skin phototype, has not yet been established. Objective: To quantify the reflection of light from PBMT on the skin of men and women aged 18 to 30 years, considering skin phototypes. Methodology: Participants will be divided into three groups based on skin phototype (Group 1: phototypes I and II; Group 2: phototypes III and IV; Group 3: phototypes V and VI) and sex. They will be subjected to whole-body PBMT with red light (660 nm; 31.85±3.85 mW; 45.50±5.07 mW/cm²) and infrared light (850 nm; 25.29±2.99 mW; 36.13±4.27 mW/cm²) at 20 cm from the light-emitting source, with measurement of light reflection in the regions of the brachial biceps, abdomen, lumbar, anterior and posterior thigh, and calf using a power and energy analyzer (powermeter PM100D and sensor S130C, 0.7 cm²). Data will be analyzed for normality and groups were compared with a significance level of 5%
NCT05336981
Hyposalivation is a condition represented by a reduced salivary flow and may include symptoms such as mouth dryness (xerostomia), pain, loss of taste,dysphagia, and dysphonia, all of which greatly affect an individual's quality of life. The aim of the present study was analized the effects of low-level light therapy irradiation (photobiomodulation PBM) on salivary gland function in patients with hyposalivation
NCT05012514
Background: Photobiomodulation therapy (PBMT) has become an adjuvant therapeutic possibility in body remodeling procedures. Although this modality emerged in 1960, there are still few studies that demonstrate the real mechanism of action and possible interaction with subcutaneous fatty tissue. Given this scenario, this study was proposed with the aim of evaluating the effects of PBMT to Light Emitting Diode (LED) associating the red (630 nm) and infrared (850 nm) wavelengths in the subcutaneous fatty tissue. Methods: This is a non-randomized controlled study of comparative intervention that evaluated a sample of subcutaneous fatty tissue from women with grade II obesity. The participants received the LED PBMT treatment with associated red and infrared wavelengths sequentially on the left side of the abdomen and the right side was considered as control, with the collection of biological material performed at the time of bariatric surgery. For histological and immunohistochemical evaluation, Caspase 3, Cleaved Caspase 3, CD68+, HSL and adipophilin markers were used.