Study of Alveolar Bone Preservation Using Photobiomodulation Combined With Grafting With Scaffold Biomaterial
Condition: Extracting Own Teeth; Bone Substitutes
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      Clinical, randomized, triple-blind, triple-blind study (the patient will not know whether or
      not he has received the laser treatment or grafted with the biomaterial, and the operator who
      will apply the laser will also be blinded to the device with or without laser irradiation.

      60 participants will be recruited to attend the dentistry clinic of Universidade Nove de
      Julho, in the courses of surgery, endodontics, and pediatric dentistry, as well as in a
      private office, with an indication for the removal of first and second upper and lower
      molars. This recruitment will only take place after approval by the ethics committee.

      4.3 Sample size: The sample size was determined based on the primary outcome of the study:
      alveolar preservation with scaffold biomaterial. Based on data from Rosero et al.
      (Photobiomodulation as adjuvant therapy for alveolar preservation: a preliminary study in
      humans) and Araújo et al. (Ridge changes after engraftment of fresh extraction sockets in
      man. A randomized clinical trial) Our initial sample size estimate was 9 subjects per group
      for a significant level of 0.05 and an estimated test power of 80% for references 104 and
      105. To account for the possible non-parametric distribution of the data, 15% more subjects
      should be added to each group. Another 25% will be added to account for possible dropouts,
      resulting in 13 participants per group and for greater safety and reliability, 15 patients
      were established in each group. G*Power 3.1.9.6 was used to perform the calculations.

      Materials used in the study:

      The biomaterial chosen for this research is the Plenum® OSShp and Plenum® Guide (Brazil)
      allograft. They are completely synthetic bone grafts and resorbable regenerating membranes
      (free of animal and human origin).

      Plenum® OSShp is a porous synthetic biphasic bioceramic (hydroxyapatite: β - tricalcium
      phosphate, HA: β-TCP - 70:30%), and the granules are 500 - 1000 µm.

      Plenum® Guide is a polydioxanone (PDO)-based synthetic membrane material whose surface
      morphology closely mimics the extracellular matrix.

      Randomization:

      All participants will be invited to participate in the research and after signing the
      informed consent will be randomized into blocks of 4; 60 participants will be randomly
      divided into 4 groups n=15 Exo (extraction), Exo+Laser (extraction and treatment with 808 nm
      laser), Exo+Biomat (extraction with biomaterial graft), Exo+Biomat+Laser (extraction and
      grafting of biomaterial and 808 nm laser treatment). Participants will be randomly allocated
      by a computer-generated list (Excel) 4.7 CLINICAL PROCEDURE: At the pre-surgical moment, the
      patient will be submitted to a CT scan (Figure 12) and intraoral scanning (Figure 13) for
      initial measurement of the vertical and horizontal bone dimensions of the alveolus and
      between the adjacent teeth of the tooth to be extracted in position in the alveolus and
      dental arch, and surgical planning, as recommended by the best current dentistry practices,
      and will sign the Image Use Authorization Term (ANNEX 4). Pre-surgical guidance and delivery
      of prescriptions with the established drug protocol will also be carried out. All research
      patients will receive the same post-surgical guidance care (ANNEX 3) and the drug protocol
      performed for all tooth removal surgery with or without grafting with biomaterials. The tooth
      will be extracted using an odontosection technique to remove the roots with the least
      possible trauma. It will not be necessary to lift the soft tissue flap due to the properties
      of the membrane that will be used, reducing tissue trauma and helping to repair the surgical
      site. After the extraction, the biomaterial will be added and accommodated to the socket with
      instruments that allow this insertion and covered by a membrane that will serve as a
      mechanical barrier, preventing the invagination of the gingival tissue and the formation of
      keratinized tissue to close the surgical wound so as not to compromise the osseointegration
      of the bone biomaterial. grafted.

      The Exo+Laser and Exo+Biomat+Laser groups will receive, in addition to the drug protocol and
      guidelines, laser treatment. The Exo and Exo+Biomat groups will use a similar laser device,
      however, it will not emit irradiation.

      In the postoperative period at 3 and 6 months, new intraoral digital scanning and digital
      computed tomography exams will be performed to take images and perform volumetric analysis
      with specific software.
    

Intervention name(s): extraction; low level laser therapy; Plenum® OSShp and Plenum® Guide
Intervention type(s): Procedure; Radiation; Biological
Intervention description(s): extraction: in all groups, extraction will be performed; extraction: in all groups, extraction will be performed Treatment with low-intensity infrared 808 nm laser therapy will be applied in 2 stages: one in the immediate postoperative period and 10 days after surgery.; extraction: in all groups, extraction will be performed Immediately after tooth extraction, the biomaterials Plenum® OSShp and Plenum® Guide (Brazil) will be added to the dental socket, serving as a bone substitute and maintaining alveolar dimensions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bone regeneration; photobiomodulation; scaffold biomaterial