Clinical trial NCT06240416: Autogenous Particles Harvesting During Implant Surgery
Official title: A Randomized Clinical Trial Comparing Autogenous Particles Harvesting During Implant Surgery Using Low-speed Drilling Without Irrigation and High-speed Drilling With Irrigation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant Failed
Keywords: Dental implants
Osteotomy
Temperature
Histology
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A split mouth randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The aim was to compare the osteoblast activity and osteogenic potential of autogenous bone particles harvested using three different techniques, determine the most advantageous method of collecting autogenous bone particles.

Bone particles were harvested during dental implant surgery using low-speed drilling and high speed drilling. After the osteoblasts were cultured, cell proliferation, migration, mineralization, transcription of osteogenesis-related genes, secretion of osteogenesis-related proteins, and osteoinductive protein content in the bone particle matrix were evaluated

Detailed description: A total of 60 individual dental implants will be placed in this study. Each patient will receive two dental implants (Spain), each measuring 10 mm in length and 4 mm in diameter, for the replacement of missing teeth in the right and left mandibular first molars. The surgery will be performed under local anesthesia (0.5% articaine with epinephrine) with the elevation of a mucoperiosteal flap. For the randomization of the implant osteotomy milling protocol in each hemimandible, an online randomization service (www.randomization.com) will be utilized.

In each patient, the conventional high-speed milling protocol with irrigation using physiological saline will be employed in one hemimandible. In the other hemimandible, the implant osteotomy will be performed using a low-speed milling protocol without irrigation.

The milling sequence for the conventional high-speed milling protocol with irrigation will be as follows: the osteotomy will be initiated with a 2.0 mm diameter marking drill, followed by a pilot drill of the same diameter. Subsequently, drills of 2.6/3.2/ and 3.6 mm diameters will be used consecutively. All drills will be used at a speed of 800 rpm and at a depth of 10 mm.

On the other hand, the milling sequence for the low-speed milling protocol without irrigation will be the same, but all drills will be used at a speed of 50 rpm (at the same depth of 10 mm). Finally, once the dental implant and closing screw are inserted, the mucoperiosteal flap will be sutured with simple stitches using synthetic polyamide suture, without immediate prosthetic loading. In all cases, postoperative medication will include 500 mg/8 h amoxicillin for 7 days (in cases of penicillin allergy, 300 mg/8 h clindamycin for 7 days), and 600 mg/8 h ibuprofen for 3 days.

Eligibility criteria: Inclusion Criteria:

* Legal age
* Informed consent signed
* Bilateral mandibular dental absence of 3.6 and 4.6 for more than 3 months
* Normal bone density in the posterior mandibular sector with type II/III bone (range of 500-850 HU) according to the classification of Norton and Gamble
* No medical contraindications for the performance of oral surgical procedures (ASA I/II).

Exclusion Criteria:

* Presence of any disease, condition, or medication that may compromise the healing and/or osseointegration of dental implants (such as diabetes mellitus, bisphosphonate administration, or severe osteoporosis)
* Presence of any severe mental disorder
* Patients who have undergone head and neck radiotherapy in the previous 18 months.

Primary outcomes:
measure: Study of the size of bone particles collected during implant osteotomy, the presence or absence of collagen fibrils, and the levels of calcium and phosphorus in them.
timeFrame: day 1
Secondary outcomes:
measure: Quantify BMP-2 and VEGF in the bone collected during implant osteotomy using conventional and low-speed milling.
timeFrame: day 14
measure: Analysis of the morphology and number of osteoblasts in the bone collected during implant osteotomy.
timeFrame: day 14
measure: Assessment of the presence of precipitated calcium nodules in the cell culture of osteoblasts after collecting bone during implant osteotomy.
timeFrame: day 21
measure: Study of cell viability (cell proliferation assay)
timeFrame: day 12
measure: Determination of the cell cycle (G0/G1, G2/M, and S)
timeFrame: day 21
measure: Assessment of cell migration capability
timeFrame: day 1
measure: Analysis cell viability ratios in the bone collected during implant osteotomy.
timeFrame: day 14
Other outcomes:
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