Autogenous Particles Harvesting During Implant Surgery

NCT06240416 | Unknown DMC

• 1 other identifier: 26302019
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Dental Implant Failed

Keywords

Dental implants; Osteotomy; Temperature; Histology

Outcome Measures

Primary Outcomes (1)

• 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.

  Once the amount of collected bone has been analyzed, 100 mg of bone will be used for the remaining study variables. The bone samples will be embedded in a 37% phosphoric acid gel for 15 seconds and then washed with plenty of water to remove the remaining acid. Subsequently, the samples will be mounted on holders for examination under the scanning electron microscope after receiving a carbon coating. After visualizing the samples at 100X, digital images will be taken for analysis using the image analysis software ImageJ. Finally, calcium and phosphorus levels will be analyzed using the Inca Microanalysis Systems software. The size will be expressed in nm.

  day 1

Secondary Outcomes (7)

• Quantify BMP-2 and VEGF in the bone collected during implant osteotomy using conventional and low-speed milling.

  day 14

• Analysis of the morphology and number of osteoblasts in the bone collected during implant osteotomy.

  day 14

• Assessment of the presence of precipitated calcium nodules in the cell culture of osteoblasts after collecting bone during implant osteotomy.

  day 21

• Study of cell viability (cell proliferation assay)

  day 12

• Determination of the cell cycle (G0/G1, G2/M, and S)

  day 21

Study Arms (2)

Control group

EXPERIMENTAL

High speed drilling (800 rpm) with irrigation

Procedure: High speed drilling with irrigation

Test group

EXPERIMENTAL

Low speed drilling (50 rpm) without irrigation

Procedure: Low speed drilling without irrigation

Interventions

Low speed drilling without irrigation PROCEDURE

Low-speed drilling (50 rpm) irrigation to perform the osteotomy

Test group

High speed drilling with irrigation PROCEDURE

High-speed drilling (800 rpm) irrigation to perform the osteotomy

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Murcia: lead

MeSH Terms

Interventions

Therapeutic Irrigation

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A split mouth randomized clinical trial

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 5, 2024
• Study Start: March 15, 2024
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: February 5, 2024

Record last verified: 2023-12