Evaluation of Alveolar Bone Preservation After Molar Extraction Using Photobiomodulation Combined With Grafting With Scaffold Biomaterial: Clinical, Randomized, Triple-blind Study.

Vanessa 1

Bone graft added to the dental socket immediately after tooth extraction prevents atrophy and deformity of the bone at the site of element loss, enabling rehabilitation with implants. Photobiomodulation accelerates bone healing; stimulates blood flow; activates osteoblasts, decreases osteoclastic activity, and improves the integration of the biomaterial with bone tissue. The study aims to develop a protocol for the management and preservation of alveolar bone after the loss of first and/or second permanent molars in patients aged between 8 and 17 years, with an indication for extraction associated or not with 808 nm infrared laser treatment. . Materials and methods: 60 patients aged between 8 and 17 years will be randomized and randomly divided into 4 groups, n= 15: Exo (extraction), Exo+Laser (extraction and laser treatment), Exo+Biomat (extraction with graft biomaterial), Exo+Biomat+Laser (biomaterial extraction and grafting and laser treatment). The biomaterials of choice will be Plenum® OSShp and Plenum® Guide (Brazil), added to the alveolus immediately after molar extraction, groups that will receive the laser (λ = 808 nm, power = 100 mW, radiant energy 3J per point in 3 buccal, occlusal and lingual/palatal points), will receive the irradiation in the surgical act, 48 hours and 10 days after the surgery, in the Exo and Exo+Biomat groups a similar laser device without emission of irradiation will be used, the operator who will apply the laser and the patient will be blind to the device used and the patient will not know whether or not he received the biomaterial. Analysis: computed tomography and intraoral scanning were performed pre-surgery, 3 and 6 months after surgery; to assess bone volume by measuring the height and width of the socket in each group, as well as trabecular bone and the interdental space of the teeth lateral to the missing element. Statistical analysis will be performed using the Shapiro-Wilks test, Student's t-test, or Wilcoxon-Mann-Whitney test for parametric and non-parametric data, respectively, they will be two-tailed and the significance level adopted will be α = 0.05.

2022-05-24

2022-08-10

2022-11-10

Completed

Early phase I

60

Inclusion Criteria: * All genders, aged between 8 and 17 years, without comorbidities, present satisfactory oral hygiene and present a condition of loss of first or second permanent molars Exclusion Criteria: * Habitual use of analgesic and anti-inflammatory medication for other comorbidities, present allergies to the proposed drug protocol, in neurological/psychiatric treatment, presence of teeth with lesions to be treated in the same hemiarch of the tooth to be removed, current smoking habit, pregnant or breast-feeding, presenting photosensitivity disorders, with the presence of neoplasia in the oral region; and patients with operative complications whose surgical time exceeds 90 minutes

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-12-08