Evaluation of Bone Preservation After Molar Extraction Using Photobiomodulation Combined With Biomaterial Grafting

NCT06164626 | Unknown Phase 1

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

Brief Summary

Tooth loss is a global public health problem and is the main cause of occlusal and oral bone deformities. The tooth with the greatest tooth loss can be identified as first molars. The bone graft added to the tooth socket immediately after tooth extraction prevents atrophy and deformity of the bone at the site of tooth loss. Photobiomodulation accelerates bone healing; stimulates blood flow; activates osteoblasts, decreases osteoclastic activity and improves the integration of the biomaterial with bone tissue. The objective of the study is to develop a protocol for the management and preservation of alveolar bone after loss of first and/or second permanent molars in patients age from 18 years, with an indication for extraction associated or not with treatment with an 808 nm infrared laser. . Materials and methods: 60 patients age from 18 years will be randomized and randomly distributed into 4 groups, n= 15: Exo (extraction), Exo+Laser (extraction and laser treatment), Exo+Biomat (extraction with graft of 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 socket 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 irradiation during surgery and 10 days after surgery, in the Exo and Exo+Biomat groups a similar laser device will be used without emission of irradiation, 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 they received the biomaterial. Analysis: computed tomography and intraoral scanning performed pre-surgery and 4 months after surgery; to assess bone volume by measurements of 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, 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 in two moments, with the tooth before extraction and after 4 months of 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 socket will be delimited based on the apex of the tooth 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. For the fractal analysis, the area of interest encompassing the dental socket will be delimited and the Image J program, which is in the public domain, will be used to calculate the fractal dimension.

  Baseline, pre surgical, 4 months

Secondary Outcomes (1)

• Interdental distance

  Baseline, pre surgical, 4 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 3; Experimental:Group 2; 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: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All genders,
• Aged over 18 years,
• Without comorbidities,
• Present satisfactory oral hygiene,
• Present a condition of loss of first or second permanent molar.

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,
• Patients with operative complications whose surgical time exceeds 90 minutes

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Uniersidade Nove de Julho

São Paulo, São Paulo, 03155-000, Brazil

RECRUITING

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MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Sandra Kalil Bussadori, PhD

CONTACT

551132283400; sandra.skb@gmail.com

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: Principal

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 11, 2023
• Study Start: December 10, 2023
• Primary Completion: June 30, 2024
• Study Completion: November 20, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available as soon as the article with the results is published in a peer-reviewed journal
• Access Criteria: The datasets from this protocol will be available from the corresponding author (Sandra Kalil Bussadorisandra.skb@gmail.com) upon any reasonable request.

Locations

BR (1)