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

December 13, 2023 updated by: Sandra Kalil Bussadori, University of Nove de Julho

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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. 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 aged 18 years and over, with indications for extraction associated or not with 808 nm infrared treatment. laser. . Materials and methods: 60 patients aged 18 years and over will be randomized and randomly distributed into 4 groups, n= 15: Exo (extraction), Exo+Laser (extraction and laser treatment), Exo+Biomat (extraction with bone graft). biomaterial), Exo+Biomat+Laser (extraction and grafting of biomaterials 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 points buccal, occlusal and lingual/palatal), 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 not have knowledge of the device used and will not know whether or not they received the biomaterial. Analysis: computed tomography performed preoperatively and 4 months after surgery; evaluate the bone volume by measuring the height and width of the socket in each group, as well as the trabecular bone and the interdental space of the teeth lateral to the missing element, and fractal analysis evaluating the volume and density of the formed bone. 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 03155-000
        • Recruiting
        • Uniersidade Nove de Julho
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Group 1
15 patients who will only have their first teeth or second molars extracted.
Procedure: Extraction
extraction: in all groups, extraction will be performed
Experimental: Experimental: Group 3
15 patients who will have their first or second molars extracted and will receive a graft with scaffold biomaterial
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.
Procedure: Extraction
extraction: in all groups, extraction will be performed
Experimental: Experimental:Group 2
15 patients who will have only their first or second molars extracted and will receive infrared laser treatment
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.
Procedure: Extraction
extraction: in all groups, extraction will be performed
Experimental: Experimental:Group 4
15 patients who will have their first or second molars extracted and will receive a graft with scaffold biomaterial and infrared laser treatment
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.
Procedure: Extraction
extraction: in all groups, extraction will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical intervention phase
Time Frame: Baseline, pre surgical, 4 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interdental distance
Time Frame: Baseline, pre surgical, 4 months
n the computed tomography, the horizontal distance will be measured with the limit in the mesial and distal bone crystals of the alveolus at two moments, pre-surgery with the tooth still in place and 4 months after extraction, to verify the maintenance of the interdental space.
Baseline, pre surgical, 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

November 20, 2024

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

December 2, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Vanessa Dalapria

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The participants' transcribed information will be transcribed into a database replacing the individuals' names with registration numbers from the initial assessment form. The datasets (Excel spreadsheet) generated from this protocol will be available from the corresponding author (Sandra Kalil Bussadorisandra.skb@gmail.com) upon reasonable request. However, reuse of this data will not be permitted by anyone other than the author of this article.

IPD Sharing Time Frame

The data will be available as soon as the article with the results is published in a peer-reviewed journal

IPD Sharing Access Criteria

The datasets from this protocol will be available from the corresponding author (Sandra Kalil Bussadorisandra.skb@gmail.com) upon any reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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