Different Surgical Techniques in Dental Implant SurgeryNCT06234566
Effect of Different Drilling Techniques on Primary Stability and Marginal Bone Loss of Extra Short Implants
A study testing Conventional dental implant surgery and Low Speed Drilling Without Irrigation in people with Different Surgical Techniques in Dental Implant Surgery, run by Erzincan University.
Trial summary
Our aim in this study is to compare the effects of low-speed drilling surgery technique without irrigation and conventional implant surgery technique with irrigation on extra short implants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Different Surgical Techniques in Dental Implant Surgery
- What is being tested?
- Conventional dental implant surgery and Low Speed Drilling Without 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
- 1 Mar 2024to 27 Dec 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- There must be toothless space in the maxillary and mandibular posterior region (distal part of the canine in each quadrant).
- The edentulous space should not require additional bone grafting.
- Bleeding areas on probing should be less than 10%
- There should be no pathological periodontal pockets
- Patients who do not smoke or smoke less than 10 cigarettes
- There should be no bruxism
- At least 6 months must have passed since the last tooth extracted from the toothless space where the implant is planned.
- There should be no diabetes.
Who cannot join
- Having psychological problems
- Smoking more than 10 cigarettes
- Alcohol and drug use
- Pregnancy
About this study
Official title: The Effect of Low Speed Drilling Without Irrigation Versus Conventional Drilling With Irrigation in Extra Short Implants on Primary Stability and Marginal Bone Loss
Our aim in this study is to compare the effects of low-speed drilling surgery technique without irrigation and conventional implant surgery technique with irrigation on extra short implants. The criteria to be taken into consideration when investigating the effect of these techniques on implants are as follows: evaluation of osseointegration at the end of three months, evaluation of marginal bone loss at the end of three months, initial insertion torque values (maximum insertion torque and final insertion torque), ISQ values obtained with a radiofrequency analyzer (Osstel) at the beginning and at the end of three months.
- Being tested
- Conventional dental implant surgery, Low Speed Drilling Without Irrigation
- Keywords
- Dental Implants, Low speed drill, Extra Short Implants, Primary Stability, Marginal Bone Loss, Osstel, Osseointegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional dental implant surgeryProcedure or surgery
It is performed to reconstruct lost teeth. These are surgical procedures performed to place dental implants in the jaw bones. To prepare the implant socket, drilling is performed with serum irrigation at a speed of 800 rpm.
Low Speed Drilling Without IrrigationProcedure or surgery
It is performed to reconstruct lost teeth. These are surgical procedures performed to place dental implants in the jaw bones. To prepare the implant socket, drilling is performed at a speed of 50 rpm without serum irrigation.
| Study group | Role | What they receive |
|---|---|---|
| Low Speed Drilling Without Irrigation | Experimental | Not described Receives: Procedure: Low Speed Drilling Without Irrigation |
| Conventional Drilling with Irrigation | Active comparator | Not described Receives: Procedure: Conventional dental implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the status of osseointegration
Fusion of the dental implant with the bone at the microscopic level. Osseointegration will be evaluated as successful or unsuccessful. Successful osseointegration is defined by no mobility in the implant, no radiolucency around the implant on radiography, and no pain in the implant. Otherwise, the osseointegration of the implant is considered unsuccessful.
Measured: Three months after the implant is placed in the bone. At the end of three months
Marginal bone lose
It defines the change in the marginal bone level in the neck area of the implant. It is determined by radiographic examination. The initial radiograph is compared with the radiograph at the end of three months. In measurements where the implant platform is the reference point, bone level changes are calculated in mm.
Measured: Three months after the implant is placed in the bone. At the end of three months
Secondary outcomes (2)
Insertion Torque value
It is the amount of compression of the implant when screwed into the bone. The value detected by the electronic device that screws the implant into the bone cavity during screwing. It is expressed in Newtons.
Measured: Surgical stage where the implant is placed
Implant Stability Quotient (ISQ Value)
The value obtained by the resonance frequency analysis (RFA) device used to measure the primary stability of dental implants. The RFA technique is based on continual excitation of the implant through dynamic vibration analysis. A transducer is connected to an implant, which is excited over a range of sound frequencies with subsequent measurement of the vibratory oscillation of the implant. It is a non-invasive technique.
Measured: 1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone. At the end of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion27 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Different Surgical Techniques in Dental Implant SurgeryStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Collaborators
- Mode Medical Implant Manufacturer
- Responsible party
- Principal investigator, Ömer Faruk Okumuş, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234566
- Sponsor's protocol ID
- EUDF-OKUMUS-001
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Speed Drilling Without Irrigation Versus Conventional Drilling With Irrigation in Extra Short Implants on Primary Stability and Marginal Bone Loss
- ClinicalTrials.gov ID
- NCT06234566
- Acronym / sponsor ID
- EUDF-OKUMUS-001
- Keywords
- Dental Implants, Low speed drill, Extra Short Implants, Primary Stability, Marginal Bone Loss, Osstel, Osseointegration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Collaborators
- Mode Medical Implant Manufacturer
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 27 Dec 2024 (estimated)
- First posted
- 31 Jan 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.
Our aim in this study is to compare the effects of low-speed drilling surgery technique without irrigation and conventional implant surgery technique with irrigation on extra short implants. The criteria to be taken into consideration when investigating the effect of these techniques on implants are as follows: evaluation of osseointegration at the end of three months, evaluation of marginal bone loss at the end of three months, initial insertion torque values (maximum insertion torque and final insertion torque), ISQ values obtained with a radiofrequency analyzer (Osstel) at the beginning and at the end of three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Speed Drilling Without Irrigation | Experimental | Procedure: Low Speed Drilling Without Irrigation |
| Conventional Drilling with Irrigation | Active comparator | Procedure: Conventional dental implant surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- There must be toothless space in the maxillary and mandibular posterior region (distal part of the canine in each quadrant).
- The edentulous space should not require additional bone grafting.
- Bleeding areas on probing should be less than 10%
- There should be no pathological periodontal pockets
- Patients who do not smoke or smoke less than 10 cigarettes
Key exclusion criteria (4 listed)
- Having psychological problems
- Smoking more than 10 cigarettes
- Alcohol and drug use
- Pregnancy
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 |
|---|---|---|
| Conventional dental implant surgeryIt is performed to reconstruct lost teeth. These are surgical procedures performed to place dental implants in the jaw bones. To prepare the implant socket, drilling is performed with serum irrigation at a speed of 800 rpm. | Procedure or surgery | Conventional Drilling with Irrigation |
| Low Speed Drilling Without IrrigationIt is performed to reconstruct lost teeth. These are surgical procedures performed to place dental implants in the jaw bones. To prepare the implant socket, drilling is performed at a speed of 50 rpm without serum irrigation. | Procedure or surgery | Low Speed Drilling Without Irrigation |
Primary outcome
Evaluation of the status of osseointegration
Time frame: Three months after the implant is placed in the bone. At the end of three months
Fusion of the dental implant with the bone at the microscopic level. Osseointegration will be evaluated as successful or unsuccessful. Successful osseointegration is defined by no mobility in the implant, no radiolucency around the implant on radiography, and no pain in the implant. Otherwise, the osseointegration of the implant is considered unsuccessful.
Marginal bone lose
Time frame: Three months after the implant is placed in the bone. At the end of three months
It defines the change in the marginal bone level in the neck area of the implant. It is determined by radiographic examination. The initial radiograph is compared with the radiograph at the end of three months. In measurements where the implant platform is the reference point, bone level changes are calculated in mm.
2 secondary outcomes
Insertion Torque value
Time frame: Surgical stage where the implant is placed
Implant Stability Quotient (ISQ Value)
Time frame: 1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone. At the end of three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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 Conventional dental implant surgery and Low Speed Drilling Without Irrigation in people with Different Surgical Techniques in Dental Implant Surgery, run by Erzincan University.
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 8 inclusion and 4 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 31 Jan 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?
Evaluation of the status of osseointegration (time frame: Three months after the implant is placed in the bone. At the end of three months). The study lists 2 primary outcomes in all. 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 31 Jan 2024.