Autogenous Particles Harvesting During Implant Surgery

NCT ID: NCT06240416

Last Updated: 2024-02-05

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-04-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Implant Failed

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A split mouth randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

High speed drilling (800 rpm) with irrigation

Group Type EXPERIMENTAL

High speed drilling with irrigation

Intervention Type PROCEDURE

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

Test group

Low speed drilling (50 rpm) without irrigation

Group Type EXPERIMENTAL

Low speed drilling without irrigation

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low speed drilling without irrigation

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

Intervention Type PROCEDURE

High speed drilling with irrigation

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

26302019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Osteoimplant and Bone Healing
NCT06664060 NOT_YET_RECRUITING EARLY_PHASE1