DentistryNCT06349421
Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation
An observational study of Dentistry and Education, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Bone quality stands as a crucial determinant impacting the success rate of dental implants, exerting influence on both implant primary stability and the efficacy of osseointegration. Read more about this study
- Who is it for?
- Ages 24 to 40 yearsHealthy volunteers can take part
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2024to 15 Oct 2024
- Phase
- Observational
- 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 24 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Board-certified dentist with age over 24 to 40 years old who has practice within 10 years and experience of Implant surgery should be less than 10 implants
Who may be able to join
- Board-certified dentist
- Practice within 10 years
- Experience of Implant surgery should be less than 10 implants
- Age: 24-40 y
Who cannot join
- 1. Unable to follow the entire test
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taiwan National University
Taipei County
wang tong mei, professor, 0972652329
About this study
Bone quality stands as a crucial determinant impacting the success rate of dental implants, exerting influence on both implant primary stability and the efficacy of osseointegration. While radiographic images can partially reveal bone quality, experienced surgeons often rely on tactile sensation during bone drilling to assess it. Subsequently, based on the diagnosed bone quality, distinct implant designs and surgical protocols have been invented to enhance survival rates.
Technological advancements now enable the preoperative design of implant placement through a comprehensive guide, merging CBCT DICOM files with digital oral scanning data. This "fully guided" approach enhances the precision, stability, and safety of implant placement surgery. However, the use of a fully guided surgical guide introduces an additional factor-the friction between the drill and guide-potentially impacting the surgeon's tactile feedback.
This study aims to assess the difference in bone quality evaluation by tactile sensation between freehand drilling and drilling with a fully guided surgical guide, using test blocks of different bone density. The discussion will explore the pros and cons of employing a fully guided guide to optimize outcomes in implant treatment.
Read the detailed description
The pilot study involves five subjects, while the main experiment will include thirty subjects. The experiment consists of two rounds, each with seven simulated bone samples. These samples include four different densities (5pcf, 5pcf, 10pcf, 10pcf, 15pcf, 15pcf, 30pcf) tested in random order. Before each round of testing, participants drill into a 50 pcf bone sample and identifying it as the hardest scale. The experiment then commences with the first round employing conventional drilling tests, followed by the second round drilling with a fully guided surgical template. After each drilling session, participants assess the hardness by recording a VAS score on a 10cm scale. The evaluation criteria utilize VAS scores as the measurement tool. The aim of this experiment is to investigate whether there are differences in the classification of bone density judged by using a fully guided surgical template compared to judgments made without using the template, under the same bone density conditions. Additionally, the study aims to determine if the use of the template affects the accuracy of bone density assessment.
- Keywords
- dental implant, bone quality, tactile sensation, fully guided surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scale at the same density of sawbone
To compare the VAS scale at the same density of sawbone between free-hand drilling and drilling with fully guided stent.
Measured: From admission to discharge, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DentistryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wang tongmei, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349421
- Sponsor's protocol ID
- 202401078RINE
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study participants only sign for this study. The personal data is promised to them should be private.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation
- ClinicalTrials.gov ID
- NCT06349421
- Acronym / sponsor ID
- 202401078RINE
- Keywords
- dental implant, bone quality, tactile sensation, fully guided surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 5 Apr 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.
Bone quality stands as a crucial determinant impacting the success rate of dental implants, exerting influence on both implant primary stability and the efficacy of osseointegration. While radiographic images can partially reveal bone quality, experienced surgeons often rely on tactile sensation during bone drilling to assess it. Subsequently, based on the diagnosed bone quality, distinct implant designs and surgical protocols have been invented to enhance survival rates.
Technological advancements now enable the preoperative design of implant placement through a comprehensive guide, merging CBCT DICOM files with digital oral scanning data. This "fully guided" approach enhances the precision, stability, and safety of implant placement surgery. However, the use of a fully guided surgical guide introduces an additional factor-the friction between the drill and guide-potentially impacting the surgeon's tactile feedback.
This study aims to assess the difference in bone quality evaluation by tactile sensation between freehand drilling and drilling with a fully guided surgical guide, using test blocks of different bone density. The discussion will explore the pros and cons of employing a fully guided guide to optimize outcomes in implant treatment.
Detailed description
The pilot study involves five subjects, while the main experiment will include thirty subjects. The experiment consists of two rounds, each with seven simulated bone samples. These samples include four different densities (5pcf, 5pcf, 10pcf, 10pcf, 15pcf, 15pcf, 30pcf) tested in random order. Before each round of testing, participants drill into a 50 pcf bone sample and identifying it as the hardest scale. The experiment then commences with the first round employing conventional drilling tests, followed by the second round drilling with a fully guided surgical template. After each drilling session, participants assess the hardness by recording a VAS score on a 10cm scale. The evaluation criteria utilize VAS scores as the measurement tool. The aim of this experiment is to investigate whether there are differences in the classification of bone density judged by using a fully guided surgical template compared to judgments made without using the template, under the same bone density conditions. Additionally, the study aims to determine if the use of the template affects the accuracy of bone density assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 24 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Board-certified dentist with age over 24 to 40 years old who has practice within 10 years and experience of Implant surgery should be less than 10 implants
Key inclusion criteria (4 listed)
- Board-certified dentist
- Practice within 10 years
- Experience of Implant surgery should be less than 10 implants
- Age: 24-40 y
Key exclusion criteria (1 listed)
- 1. Unable to follow the entire test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VAS scale at the same density of sawbone
Time frame: From admission to discharge, up to 1 year
To compare the VAS scale at the same density of sawbone between free-hand drilling and drilling with fully guided stent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No. The study participants only sign for this study. The personal data is promised to them should be private.
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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.
wang tongmei study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentistry and Education, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 1 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 lee hsuan yi (886910007711, sophycoco1015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS scale at the same density of sawbone (time frame: From admission to discharge, up to 1 year). 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 8 May 2024.