Evaluation of Bone Preservation After Molar Extraction Using Photobiomodulation Combined With Biomaterial Grafting
NCT ID: NCT06164626
Last Updated: 2023-12-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-12-10
Study Completion Date
2024-11-20
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Extracting Own Teeth
Bone Substitutes
Keywords
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Bone regeneration
photobiomodulation
scaffold biomaterial
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Experimental: Group 1
15 patients who will only have their first teeth or second molars extracted.
Group Type
EXPERIMENTAL
Extraction
Intervention Type
PROCEDURE
extraction: in all groups, extraction will be performed
Experimental:Group 2
15 patients who will have only their first or second molars extracted and will receive infrared laser treatment
Group Type
EXPERIMENTAL
Extraction
Intervention Type
PROCEDURE
extraction: in all groups, extraction will be performed
low level laser therapy
Intervention Type
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 3
15 patients who will have their first or second molars extracted and will receive a graft with scaffold biomaterial
Group Type
EXPERIMENTAL
Extraction
Intervention Type
PROCEDURE
extraction: in all groups, extraction will be performed
Plenum® OSShp and Plenum® Guide
Intervention Type
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 4
15 patients who will have their first or second molars extracted and will receive a graft with scaffold biomaterial and infrared laser treatment
Group Type
EXPERIMENTAL
Extraction
Intervention Type
PROCEDURE
extraction: in all groups, extraction will be performed
low level laser therapy
Intervention Type
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.
Plenum® OSShp and Plenum® Guide
Intervention Type
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.
Interventions
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Extraction
extraction: in all groups, extraction will be performed
Intervention Type
PROCEDURE
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.
Intervention Type
RADIATION
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.
Intervention Type
BIOLOGICAL
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Nove de Julho
OTHER
Sponsor Role
lead
Responsible Party
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Sandra Kalil Bussadori
Principal
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Uniersidade Nove de Julho
São Paulo, São Paulo, Brazil
Site Status
RECRUITING
Countries
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Brazil
Central Contacts
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Facility Contacts
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Sandra Kalil Bussadori, PhD
Role: primary
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Vanessa Dalapria
Identifier Type: -
Identifier Source: org_study_id