Dental Implant FailedNCT06240416
Autogenous Particles Harvesting During Implant Surgery
A study testing Low speed drilling without irrigation and High speed drilling with irrigation in people with Dental Implant Failed, run by Universidad de Murcia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Low speed drilling without irrigation and High speed drilling with irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 5 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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
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
Read the 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.
- Conditions
- Dental Implant Failed
- Being tested
- Low speed drilling without irrigation, High speed drilling with irrigation
- Keywords
- Dental implants, Osteotomy, Temperature, Histology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low speed drilling without irrigationProcedure or surgery
Low-speed drilling (50 rpm) irrigation to perform the osteotomy
High speed drilling with irrigationProcedure or surgery
High-speed drilling (800 rpm) irrigation to perform the osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | High speed drilling (800 rpm) with irrigation Receives: Procedure: High speed drilling with irrigation |
| Test group | Experimental | Low speed drilling (50 rpm) without irrigation Receives: Procedure: Low speed drilling without irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (7)
Quantify BMP-2 and VEGF in the bone collected during implant osteotomy using conventional and low-speed milling.
The sterile Eppendorf tubes containing 100 mg of collected bone with one of the two compared protocols will be centrifuged at 217 g for 6 minutes. The supernatant will be collected and used to quantify BMP-2 and VEGF using an ELISA kit. The procedure will be carried out following the protocol provided by the manufacturer. Absorbance at 405 nm will be measured using an EXL-800 type ELISA reader.
The variable will be expressed in % per 100mg
Measured: day 14
Analysis of the morphology and number of osteoblasts in the bone collected during implant osteotomy.
To compare the morphology and number of osteoblasts in the bone collected during the milling sequence with the two compared protocols, the 100 mg of bone will be immediately cultured in α-MEM supplemented with fetal bovine serum and 1% antibiotic (penicillin 10,000 U/ml and streptomycin 10,000 µg/ml) The culture medium will be changed every 3 days.
The morphology and number of cultured osteoblasts will be observed at 7 and 14 days. After visualization under a 40X optical microscope, the morphology will be described as normal or abnormal.
The variable will be expressed in % per 100mg
Measured: day 14
Assessment of the presence of precipitated calcium nodules in the cell culture of osteoblasts after collecting bone during implant osteotomy.
To compare the possible presence of precipitated calcium nodules in the cell culture of osteoblasts after collecting bone during the milling sequence with the two compared protocols, we will use the fourth passage of cultured osteoblasts (at 21 days of cultivation). Cells will be washed with PBS, fixed with 75% cold ethanol for 1 hour, and incubated with 1 ml of 0.1% alizarin red at pH 8.3 (Sigma-Aldrich Quimica S.A., Madrid, Spain) for 10 minutes. Then, if there are precipitated calcium nodules, they will be stained red and observed under the optical microscope. Finally, we will use a solution of 20% methanol and 10% acetic acid for 10 minutes to dissolve the alizarin red. Results will be expressed qualitatively by measuring absorbance at 550 nm using an EXL-800 type ELISA reader.
The variable will be expressed in %
Measured: day 21
Study of cell viability (cell proliferation assay)
We will also use the fourth passage of cultured osteoblasts (at 21 days of cultivation). The cells will be seeded in 96-well culture plates at a density of 1 X 103 cells per well. Cell proliferation will be assessed at 2, 6, and 12 days of incubation using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-2H-tetrazolium bromide (MTT) assay. First, 20 µl of MTT (Sigma-Aldrich Quimica S.A., Madrid, Spain) will be added to the medium and incubated for 4 hours. Subsequently, we will remove the medium and add 150 µl of dimethyl sulfoxide (Sigma-Aldrich Quimica S.A., Madrid, Spain) to each well. The results will be analyzed by measuring absorbance at 490 nm.
The variable will be expressed in %
Measured: day 12
Determination of the cell cycle (G0/G1, G2/M, and S)
For the study of the cell cycle, we will also use the fourth passage of cultured osteoblasts (at 21 days of cultivation). Cells will be detached from the cell culture flasks using 0.05% trypsin (Sigma-Aldrich Quimica S.A., Madrid, Spain) and 0.02% EDTA. Afterward, they will be washed and suspended in PBS for cell cycle analysis. The cells will be incubated at 37º C for 30 minutes with 100 ml of RNase (1 mg/ml) and 100 ml of propidium iodide.
The DNA content of the stained cells will be studied using a FACSCaliburTM flow cytometer with a 488 nm argon laser to collect forward scatter (FSC), side scatter (SSC), and propidium iodide fluorescence intensity (PLA-2) data from 2000 events. The data will be analyzed using the CELLQUEST software and the MODFIT program, determining the percentage of cells in G0/G1, G2/M, and S phases.
The variable will be expressed in %
Measured: day 21
Assessment of cell migration capability
For the study of cell migration capability, we will also use the fourth passage of cultured osteoblasts (at 21 days of cultivation). Cells will be seeded in 6-well culture plates at a density of 5 X 104 cells per well and incubated for 24 hours to reach 100% confluence. Subsequently, 3 parallel lines will be drawn in each well using a sterile 300 µl pipette tip to create empty cell spaces, and cell migration will be observed at 6, 12, and 24 hours.
Cell migration will be determined using the MIP-4.5 image analysis system. Using digital images of each well at 6, 12, and 24 hours, 10 lines of separation/approach of the empty cell spaces will be measured, and the distance traveled by the cells will be calculated using the formula: migration distance = (A0/2) - (At/2), where A0 is the initial width of the cell-free space, and At is the width of the cell-free space at 6, 12, or 24 hours.
The variable will be expressed in %
Measured: day 1
Analysis cell viability ratios in the bone collected during implant osteotomy.
Cell viability ratios of osteoblasts will be studied on day 14. Cells will be separated from the cell culture flasks using 0.05% trypsin (Sigma-Aldrich Quimica S.A., Madrid, Spain) and quantified using a Neubauer chamber. Then, cells will be stained with trypan blue to determine cell viability ratios.
The variable will be expressed in % per 100mg
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Mar 2024 (estimated)
- Primary completion5 Apr 2024 (estimated)
- Study completion5 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A split mouth randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240416
- Sponsor's protocol ID
- 26302019
- Status last verified
- Dec 2023
- First submitted
- 9 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06240416
- Acronym / sponsor ID
- 26302019
- Conditions
- Dental Implant Failed
- Keywords
- Dental implants, Osteotomy, Temperature, Histology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 5 Apr 2024 (estimated)
- Study completion
- 5 Apr 2024 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A split mouth randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: High speed drilling with irrigationHigh speed drilling (800 rpm) with irrigation |
| Test group | Experimental | Procedure: Low speed drilling without irrigationLow speed drilling (50 rpm) without irrigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low speed drilling without irrigationLow-speed drilling (50 rpm) irrigation to perform the osteotomy | Procedure or surgery | Test group |
| High speed drilling with irrigationHigh-speed drilling (800 rpm) irrigation to perform the osteotomy | Procedure or surgery | Control group |
Primary outcome
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.
Time frame: day 1
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.
7 secondary outcomes
Quantify BMP-2 and VEGF in the bone collected during implant osteotomy using conventional and low-speed milling.
Time frame: day 14
Analysis of the morphology and number of osteoblasts in the bone collected during implant osteotomy.
Time frame: day 14
Assessment of the presence of precipitated calcium nodules in the cell culture of osteoblasts after collecting bone during implant osteotomy.
Time frame: day 21
Study of cell viability (cell proliferation assay)
Time frame: day 12
Determination of the cell cycle (G0/G1, G2/M, and S)
Time frame: day 21
Assessment of cell migration capability
Time frame: day 1
Analysis cell viability ratios in the bone collected during implant osteotomy.
Time frame: day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low speed drilling without irrigation and High speed drilling with irrigation in people with Dental Implant Failed, run by Universidad de Murcia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.