Implant PlacementNCT06519383
Comparison Of Implant Position Achieved With Fully Guided Versus Partially Guided Implant Placement
A study testing guided implant surgery in people with Implant Placement, run by Krishnadevaraya College of Dental Sciences & Hospital.
Trial summary
Globally implant therapy is currently accepted as a predictable, viable and successful option to replace missing teeth. Ample studies have shown excellent survival and clinical success rates of dental implants for various indications.The correct three-dimensional (3D) positioning of an implant is considered a… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Placement
- What is being tested?
- guided implant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Aug 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients in need of replacement of missing teeth.
- Mouth opening at least 30 mm.
- Age>18 years.
- Limited vertical or horizontal dimension of the alveolar ridge.
- Unfavorable bone morphology necessitating correct implant position.
- When minimally invasive (e.g. flapless) surgery is intended.
- When immediate implant restoration is planned.
Who cannot join
- Heavy smokers (more than 10 cigarettes per day)
- Uncontrolled diabetes
- Metabolic bone disorders
- History of radiotherapy of the head and neck
- Recent chemotherapy
- Use of drugs influencing bone or soft tissue healing (e.g., high doses of antiresorptive medication, steroids or anti-inflammatory drugs)
- Pregnant and/or lactating women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Evaluation Of Accuracy Of Implant Position Achieved With Static Computer Assisted Fully Guided Implant Placement (sCAIP) And Conventional Cast Based Partially Guided Implant Placement (cPGIP)
Globally implant therapy is currently accepted as a predictable, viable and successful option to replace missing teeth. Ample studies have shown excellent survival and clinical success rates of dental implants for various indications.The correct three-dimensional (3D) positioning of an implant is considered a prerequisite for an optimal outcome.Computer assisted implant surgery maybe beneficial in patients with limited bone and proximity to anatomic structures.Therefore, the aim of this randomized controlled clinical trial is to investigate the accuracy of implant position achieved with static CAIP(Computer Assisted Implant Placement) and to compare this with the accuracy of conventional cast based partially guided implant placement(cPGIP).
Read the detailed description
Globally implant therapy is currently accepted as a predictable, viable and successful option to replace missing teeth.As a result, the focus in contemporary implant dentistry has shifted towards the optimization of treatment concepts with aesthetics and function as an important outcome parameter.In this respect, implant installation should be prosthetically -driven, at the same time taking into account anatomical limitations as well as restrictions in terms of bone availability. Apart from aesthetics, a correct implant position may reduce biological and technical complications, favourable esthetic and prosthetic outcome, long term stability of peri-implant tissues, optimal occlusal contacts and implant loading. One possible tool that may facilitate a more accurate implant positioning is guided implant surgery.Virtual implant planning facilitates desired inter implant distance and depth. A top down planning wherein digital images of the edentulous area and mock wax up of the prosthesis is superimposed, allows precise implant placement planning. This digital planning can be converted into a surgical/virtual guide via a 3D printer or a milling machine.Fully guided surgery is based on a surgical guide which will assist the clinician in every step of the surgery starting from the first drill to the implant placement through the use of guiding sleeves in the guide. A partially-guided protocol differs only in the final step: after guided preparation of the osteotomy, the guide is removed and the implant is installed free-handedly.Therefore, the aim of this randomized controlled clinical trial is to investigate the accuracy of implant position achieved with static CAIP(Computer Assisted Implant Placement) and to compare this with the accuracy of conventional cast based partially guided implant placement(cPGIP).
- Conditions
- Implant Placement
- Being tested
- guided implant surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided implant surgeryProcedure or surgery
Surgical guide is fabricated and fitted onto the patient's arch and implant is placed with guide in place.
| Study group | Role | What they receive |
|---|---|---|
| Implant placement by static computer assisted implant placement(fully guided). | Experimental | The Digital Imaging and Communications in Medicine (DICOM) file from the CBCT examination and the Standard Tessellation Language (STL) file from the surface scan will be imported and merged in planning software .The virtual implant planning for all patients will be performed in 3shape software.Surgical guide with embedded sleeve will be designed and 3D printed using computer-aided design/computer-aided manufacturing (CAD/CAM) technology.Fit and stability of static CAD\CAM surgical guide for test group will be verified through window areas of guide on top of the teeth.A flapless implant placement protocol will be performed for all implants. Receives: Procedure: guided implant surgery |
| Implant placement by conventional cast based partially guided implant placement(partially guided). | Experimental | A conventional acrylic stent with radiopaque marker (barium sulphate) will be fabricated which will serve as radiographic template.A CBCT (cone beam computed tomography) examination will be performed with the patient wearing radiographic template.The DICOM file will be then imported in planning software. Virtual implant planning will be performed in 3 shape software.A surgical stent will be produced in a conventional laboratory manner. A flapless implant placement protocol will be performed. Receives: Procedure: guided implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of implant position
3D deviation of planned implant position to final implant position
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant PlacementStudies 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, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519383
- Sponsor's protocol ID
- 02_D012_00047
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 25 Jul 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 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation Of Accuracy Of Implant Position Achieved With Static Computer Assisted Fully Guided Implant Placement (sCAIP) And Conventional Cast Based Partially Guided Implant Placement (cPGIP)
- ClinicalTrials.gov ID
- NCT06519383
- Acronym / sponsor ID
- 02_D012_00047
- Conditions
- Implant Placement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 25 Jul 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.
Globally implant therapy is currently accepted as a predictable, viable and successful option to replace missing teeth. Ample studies have shown excellent survival and clinical success rates of dental implants for various indications.The correct three-dimensional (3D) positioning of an implant is considered a prerequisite for an optimal outcome.Computer assisted implant surgery maybe beneficial in patients with limited bone and proximity to anatomic structures.Therefore, the aim of this randomized controlled clinical trial is to investigate the accuracy of implant position achieved with static CAIP(Computer Assisted Implant Placement) and to compare this with the accuracy of conventional cast based partially guided implant placement(cPGIP).
Detailed description
Globally implant therapy is currently accepted as a predictable, viable and successful option to replace missing teeth.As a result, the focus in contemporary implant dentistry has shifted towards the optimization of treatment concepts with aesthetics and function as an important outcome parameter.In this respect, implant installation should be prosthetically -driven, at the same time taking into account anatomical limitations as well as restrictions in terms of bone availability. Apart from aesthetics, a correct implant position may reduce biological and technical complications, favourable esthetic and prosthetic outcome, long term stability of peri-implant tissues, optimal occlusal contacts and implant loading. One possible tool that may facilitate a more accurate implant positioning is guided implant surgery.Virtual implant planning facilitates desired inter implant distance and depth. A top down planning wherein digital images of the edentulous area and mock wax up of the prosthesis is superimposed, allows precise implant placement planning. This digital planning can be converted into a surgical/virtual guide via a 3D printer or a milling machine.Fully guided surgery is based on a surgical guide which will assist the clinician in every step of the surgery starting from the first drill to the implant placement through the use of guiding sleeves in the guide. A partially-guided protocol differs only in the final step: after guided preparation of the osteotomy, the guide is removed and the implant is installed free-handedly.Therefore, the aim of this randomized controlled clinical trial is to investigate the accuracy of implant position achieved with static CAIP(Computer Assisted Implant Placement) and to compare this with the accuracy of conventional cast based partially guided implant placement(cPGIP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implant placement by static computer assisted implant placement(fully guided). | Experimental | Procedure: guided implant surgeryThe Digital Imaging and Communications in Medicine (DICOM) file from the CBCT examination and the Standard Tessellation Language (STL) file from the surface scan will be imported and merged in planning software .The virtual implant planning for all patients will be performed in 3shape software.Surgical guide with embedded sleeve will be designed and 3D printed using computer-aided design/computer-aided manufacturing (CAD/CAM) technology.Fit and stability of static CAD\CAM surgical guide for test group will be verified through window areas of guide on top of the teeth.A flapless implant placement protocol will be performed for all implants. |
| Implant placement by conventional cast based partially guided implant placement(partially guided). | Experimental | Procedure: guided implant surgeryA conventional acrylic stent with radiopaque marker (barium sulphate) will be fabricated which will serve as radiographic template.A CBCT (cone beam computed tomography) examination will be performed with the patient wearing radiographic template.The DICOM file will be then imported in planning software. Virtual implant planning will be performed in 3 shape software.A surgical stent will be produced in a conventional laboratory manner. A flapless implant placement protocol will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients in need of replacement of missing teeth.
- Mouth opening at least 30 mm.
- Age>18 years.
- Limited vertical or horizontal dimension of the alveolar ridge.
- Unfavorable bone morphology necessitating correct implant position.
Key exclusion criteria (7 listed)
- Heavy smokers (more than 10 cigarettes per day)
- Uncontrolled diabetes
- Metabolic bone disorders
- History of radiotherapy of the head and neck
- Recent chemotherapy
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 |
|---|---|---|
| guided implant surgerySurgical guide is fabricated and fitted onto the patient's arch and implant is placed with guide in place. | Procedure or surgery | Implant placement by conventional cast based partially guided implant placement(partially guided)., Implant placement by static computer assisted implant placement(fully guided). |
Primary outcome
Accuracy of implant position
Time frame: 2 weeks
3D deviation of planned implant position to final implant position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing guided implant surgery in people with Implant Placement, run by Krishnadevaraya College of Dental Sciences & Hospital.
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 7 inclusion and 7 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 25 Jul 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?
Contact Dr. Prabhuji MLV, MDS (9448057407 ext. 91, prabhujimlv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of implant position (time frame: 2 weeks). 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 25 Jul 2024.