Clinical trial NCT06164626: Evaluation of Bone Preservation After Molar Extraction Using Photobiomodulation Combined With Biomaterial Grafting
Official title: Evaluation of Alveolar Bone Preservation After Early Molar Extraction Using Photobiomodulation Combined With Grafting With Scaffold Biomaterial: Clinical, Randomized, Triple-blind Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Extracting Own Teeth
Bone Substitutes
Keywords: Bone regeneration
photobiomodulation
scaffold biomaterial
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical intervention phase
timeFrame: Baseline, pre surgical, 4 months
Secondary outcomes:
measure: Interdental distance
timeFrame: Baseline, pre surgical, 4 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Uniersidade Nove de Julho
state: SP
Study officials:
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