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

Bone Substitutes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164626
• Other study ID #: Vanessa Dalapria
• Status: Recruiting
• Phase: Phase 1
• Start date: December 10, 2023
• Est. completion date: November 20, 2024

Study information

• Verified date: December 2023
• Source: University of Nove de Julho
• Contact: Sandra Kalil Bussadori, PhD
• Phone: 551132283400
• Email: sandra.skb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 20, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Substitutes

Intervention

Procedure:
• Extraction
extraction: in all groups, extraction will be performed

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.

Locations

Country	Name	City	State
Brazil	Uniersidade Nove de Julho	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

References & Publications (73)

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* Note: There are 73 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Interdental distance	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