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

NCT06150456 | Completed Phase 1

• 1 other identifier: Vanessa 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bone regeneration; photobiomodulation; scaffold biomaterial

Outcome Measures

Primary Outcomes (1)

• Surgical intervention phase

  The computed tomography examination will be carried out pre-surgery, with the tooth before extraction and after 3 and 6 months after surgery and the measurements chosen for the dimensional measurement of the alveolar process will refer to the buccolingual thickness of the alveolus. In the orthoradial cut, the limits of the alveolus will be delimited based on the tooth apex to the maximum height of the bone crests. In the most central position, the vertical measurement will be taken and 3 buccolingual cuts will be made, proportional to each other according to the measured vertical measurement; and in each apical, middle and cervical third, measurements will be taken regarding the horizontal dimensions of the alveolus. In the intraoral scanning examination, the mesio-distal measurements will be measured from the mesial bone crest to the distal bone crest, and the buccal-lingual measurements in the most central portion of the dental socket.

  Baseline, pre surgical, 3 and 6 months

Secondary Outcomes (1)

• Interdental distance

  Baseline, pre surgical, 3 and 6 months

Study Arms (4)

Experimental: Group 1

EXPERIMENTAL

15 patients who will only have their first teeth or second molars extracted.

Procedure: extraction

Experimental: Group 2

EXPERIMENTAL

15 patients who will have only their first or second molars extracted and will receive infrared laser treatment

Procedure: extraction; Radiation: low level laser therapy

Experimental: Group 3

EXPERIMENTAL

15 patients who will have their first or second molars extracted and will receive a graft with scaffold biomaterial

Procedure: extraction; Biological: Plenum® OSShp and Plenum® Guide

Experimental: Group 4

EXPERIMENTAL

15 patients who will have their first or second molars extracted and will receive a graft with scaffold biomaterial and infrared laser treatment

Procedure: extraction; Radiation: low level laser therapy; Biological: Plenum® OSShp and Plenum® Guide

Interventions

extraction PROCEDURE

extraction: in all groups, extraction will be performed

Experimental: Group 1; Experimental: Group 2; Experimental: Group 3; Experimental: Group 4

low level laser therapy RADIATION

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.

Experimental: Group 2; Experimental: Group 4

Plenum® OSShp and Plenum® Guide BIOLOGICAL

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.

Experimental: Group 3; Experimental: Group 4

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho

São Paulo, 01525-000, Brazil

Location

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MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Vanessa Dalapria

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 29, 2023
• Study Start: May 24, 2022
• Primary Completion: August 10, 2022
• Study Completion: November 10, 2022
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

BR (1)