Study of Alveolar Bone Preservation Using Photobiomodulation Combined With Grafting With Scaffold Biomaterial

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.

Conditions

• Extracting Own Teeth
• Bone Substitutes

Interventions

PROCEDURE

extraction

extraction: in all groups, extraction will be performed

RADIATION

low level laser therapy

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.

BIOLOGICAL

Plenum® OSShp and Plenum® Guide

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.

Sponsors & Collaborators

• University of Nove de Julho

  lead OTHER

Principal Investigators

• Vanessa Dalapria · University of Nove de Julho

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-24

Primary Completion

2022-08-10

Completion

2022-11-10

Countries

• Brazil

Study Locations