Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification TechniqueBIDOSNCT06268639
Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique
A study testing Osseodensification in people with Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique, run by King Khalid University.
Trial summary
The study investigates the impact of osseodensification drills on bone density changes surrounding dental implants. Osseodensification, a novel technique, is hypothesized to enhance primary stability of implants by densifying bone rather than removing it during osteotomy. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique
- What is being tested?
- Osseodensification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2024to 30 Jun 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with partial or complete edentulous ridge in the maxilla or mandible.
Who cannot join
- Presence of a fractured jaw.
- General bone or blood disorders that may affect osseointegration
Trial locations and contacts
No sites are listed yet.
About this study
The study investigates the impact of osseodensification drills on bone density changes surrounding dental implants. Osseodensification, a novel technique, is hypothesized to enhance primary stability of implants by densifying bone rather than removing it during osteotomy. Participants undergo pre-operative and post-operative DentaScan CT analyses to measure bone density in Hounsfield units at apical, mesial, and distal positions around the implant sites. This intervention-based research aims to quantify the benefits of osseodensification in improving bone quality and implant success. Data from 32 sites, analyzed via the Radiant DICOM software, undergo statistical examination using SPSS to ascertain significant differences in bone density pre- and post-surgery. The outcome could redefine surgical approaches in implantology, emphasizing osseodensification's role in achieving superior bone-implant integration.
Read the detailed description
Study Design The research is an interventional study targeting a single group of patients slated for dental implant placement, incorporating a total of 32 implant sites for detailed analysis. The study is meticulously designed to track each participant through sequential phases, including pre-operative evaluation, the surgical intervention employing osseodensification drills, and a thorough post-operative assessment to gauge the technique's impact on bone density and implant stability.
Pre-operative Evaluation Participants undergo a comprehensive dental examination before the surgical procedure, which includes DentaScan CT imaging conducted at Rohilkhand Medical College and Hospital's Department of Radiology. The imaging, analyzed using Radiant DICOM software, facilitates precise measurement of bone density at strategic locations around the planned implant sites, specifically at apical, mesial, and distal positions. These measurements, recorded in Hounsfield units, establish baseline bone density values for each site, grouped as Group 1 for analysis.
Surgical Procedure Implant placement surgeries are carried out under local anesthesia in the Department of Prosthodontics. Initial osteotomy sites are prepared using a pilot drill, followed by the application of osseodensification drills (VT1525 and VT2535) in a non-cutting, counterclockwise direction to expand and densify the bone at the osteotomy sites. This technique is theorized to enhance primary stability of the implants by improving bone density.
Post-operative Evaluation Post-surgery, patients receive instructions and medications for post-operative care. A follow-up DentaScan CT is performed to assess changes in bone density at the implant sites, comparing these post-operative measurements to the pre-operative baselines to evaluate the effectiveness of the osseodensification technique.
Data Analysis Data from pre-operative and post-operative evaluations are systematically recorded and analyzed using SPSS software. A student paired t-test is utilized to ascertain the significance of changes in bone density, with a p-value of less than 0.05 deemed statistically significant.
Objective The primary aim is to ascertain whether the use of osseodensification drilling techniques yields a measurable improvement in bone density around implant sites, potentially enhancing dental implant success rates by fostering better primary stability and facilitating osseointegration.
Significance The study seeks to offer empirical evidence supporting the application of osseodensification in dental implantology. By rigorously assessing the technique's impact on bone density and implant stability, the research endeavors to make a meaningful contribution to surgical practices in dental implant placement, aiming to ultimately enhance patient outcomes by leveraging this innovative technique.
- Being tested
- Osseodensification
- Keywords
- Osseodensification, Dental implants, Bone density, Primary stability, Osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseodensificationProcedure or surgery
The intervention, osseodensification, involves a surgical technique using specific drills (e.g., Densah burs) rotated in a counterclockwise direction to compact bone rather than remove it, thereby increasing bone density around the implant site. This method is aimed at improving the primary stability of dental implants by creating a denser bone environment, which theoretically should lead to better osseointegration and long-term success of the implant. The technique distinguishes itself from traditional drilling by preserving and enhancing bone structure, which is crucial for the success of dental implants in patients.
| Study group | Role | What they receive |
|---|---|---|
| Osseodensification in Dental Implant Surgery | Experimental | The arm involves participants undergoing dental implant surgery with the use of osseodensification drills. This technique is intended to enhance bone density and improve the primary stability of the implants by compacting bone rather than removing it during the osteotomy process. The study aims to assess the impact of osseodensification on bone density at the implant sites, comparing pre-operative and post-operative bone density measurements to evaluate the effectiveness of this intervention. Receives: Procedure: Osseodensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Bone Density at Implant Sites Using Osseodensification Technique
The primary outcome measure is the change in bone density at the dental implant sites, measured in Hounsfield units (HU), from pre-operative to post-operative stages. The study aims to quantify the effectiveness of the osseodensification technique in enhancing bone density around the implant sites, thereby potentially improving the primary stability of dental implants. The outcome will be assessed using DentaScan CT imaging analyzed with Radiant DICOM software to compare bone density values at apical, mesial, and distal positions relative to each implant site before and after the surgical intervention.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start20 Mar 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification TechniqueStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study employs a single-group, interventional model to examine the impact of osseodensification on bone density at dental implant sites. It involves a sequential process starting from pre-operative bone density assessment using DentaScan CT, followed by surgical intervention using osseodensification drills, and concluding with a post-operative bone density evaluation to compare changes. This approach aims to determine if osseodensification can significantly enhance bone density and stability around implant sites, thereby potentially improving the success rates of dental implants. The methodology includes detailed pre-operative and post-operative assessments, with statistical analysis conducted to evaluate the effectiveness of the intervention.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Kumar Vaddamanu, King Khalid University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268639
- Sponsor's protocol ID
- ECM#2024-216
- Other IDs
- RGP1/347/44
- Acronym
- BIDOS
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study aims to share specific individual participant data related to the osseodensification technique's effect on bone density around dental implant sites. Data to be shared includes pre-operative and post-operative bone density measurements at specified implant sites, measured in Hounsfield units, and statistical analyses comparing these measurements. The data will be anonymized to protect participant confidentiality and shared with researchers who provide a methodologically sound proposal for purposes of advancing knowledge in dental implant stability and bone density impacts. Data will be available upon request following publication of the study results, subject to approval by the study's ethical review board and under a data-sharing agreement that specifies data use, security requirements, and data destruction upon project completion.
Publications
Vaddamanu SK, Saini RS, Vyas R, Kanji MA, Alshadidi AAF, Hafedh S, Cicciu M, Minervini G. A comparative study on bone density before and after implant placement using osseodensification technique: a clinical evaluation. Int J Implant Dent. 2024 Nov 19;10(1):56. doi: 10.1186/s40729-024-00565-8.
PubMed 39560860
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique
- ClinicalTrials.gov ID
- NCT06268639
- Acronym / sponsor ID
- BIDOS / ECM#2024-216
- Keywords
- Osseodensification, Dental implants, Bone density, Primary stability, Osteotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 20 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 study investigates the impact of osseodensification drills on bone density changes surrounding dental implants. Osseodensification, a novel technique, is hypothesized to enhance primary stability of implants by densifying bone rather than removing it during osteotomy. Participants undergo pre-operative and post-operative DentaScan CT analyses to measure bone density in Hounsfield units at apical, mesial, and distal positions around the implant sites. This intervention-based research aims to quantify the benefits of osseodensification in improving bone quality and implant success. Data from 32 sites, analyzed via the Radiant DICOM software, undergo statistical examination using SPSS to ascertain significant differences in bone density pre- and post-surgery. The outcome could redefine surgical approaches in implantology, emphasizing osseodensification's role in achieving superior bone-implant integration.
Detailed description
Study Design The research is an interventional study targeting a single group of patients slated for dental implant placement, incorporating a total of 32 implant sites for detailed analysis. The study is meticulously designed to track each participant through sequential phases, including pre-operative evaluation, the surgical intervention employing osseodensification drills, and a thorough post-operative assessment to gauge the technique's impact on bone density and implant stability.
Pre-operative Evaluation Participants undergo a comprehensive dental examination before the surgical procedure, which includes DentaScan CT imaging conducted at Rohilkhand Medical College and Hospital's Department of Radiology. The imaging, analyzed using Radiant DICOM software, facilitates precise measurement of bone density at strategic locations around the planned implant sites, specifically at apical, mesial, and distal positions. These measurements, recorded in Hounsfield units, establish baseline bone density values for each site, grouped as Group 1 for analysis.
Surgical Procedure Implant placement surgeries are carried out under local anesthesia in the Department of Prosthodontics. Initial osteotomy sites are prepared using a pilot drill, followed by the application of osseodensification drills (VT1525 and VT2535) in a non-cutting, counterclockwise direction to expand and densify the bone at the osteotomy sites. This technique is theorized to enhance primary stability of the implants by improving bone density.
Post-operative Evaluation Post-surgery, patients receive instructions and medications for post-operative care. A follow-up DentaScan CT is performed to assess changes in bone density at the implant sites, comparing these post-operative measurements to the pre-operative baselines to evaluate the effectiveness of the osseodensification technique.
Data Analysis Data from pre-operative and post-operative evaluations are systematically recorded and analyzed using SPSS software. A student paired t-test is utilized to ascertain the significance of changes in bone density, with a p-value of less than 0.05 deemed statistically significant.
Objective The primary aim is to ascertain whether the use of osseodensification drilling techniques yields a measurable improvement in bone density around implant sites, potentially enhancing dental implant success rates by fostering better primary stability and facilitating osseointegration.
Significance The study seeks to offer empirical evidence supporting the application of osseodensification in dental implantology. By rigorously assessing the technique's impact on bone density and implant stability, the research endeavors to make a meaningful contribution to surgical practices in dental implant placement, aiming to ultimately enhance patient outcomes by leveraging this innovative technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study employs a single-group, interventional model to examine the impact of osseodensification on bone density at dental implant sites. It involves a sequential process starting from pre-operative bone density assessment using DentaScan CT, followed by surgical intervention using osseodensification drills, and concluding with a post-operative bone density evaluation to compare changes. This approach aims to determine if osseodensification can significantly enhance bone density and stability around implant sites, thereby potentially improving the success rates of dental implants. The methodology includes detailed pre-operative and post-operative assessments, with statistical analysis conducted to evaluate the effectiveness of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Osseodensification in Dental Implant Surgery | Experimental | Procedure: OsseodensificationThe arm involves participants undergoing dental implant surgery with the use of osseodensification drills. This technique is intended to enhance bone density and improve the primary stability of the implants by compacting bone rather than removing it during the osteotomy process. The study aims to assess the impact of osseodensification on bone density at the implant sites, comparing pre-operative and post-operative bone density measurements to evaluate the effectiveness of this intervention. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with partial or complete edentulous ridge in the maxilla or mandible.
Key exclusion criteria (2 listed)
- Presence of a fractured jaw.
- General bone or blood disorders that may affect osseointegration
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 |
|---|---|---|
| OsseodensificationThe intervention, osseodensification, involves a surgical technique using specific drills (e.g., Densah burs) rotated in a counterclockwise direction to compact bone rather than remove it, thereby increasing bone density around the implant site. This method is aimed at improving the primary stability of dental implants by creating a denser bone environment, which theoretically should lead to better osseointegration and long-term success of the implant. The technique distinguishes itself from traditional drilling by preserving and enhancing bone structure, which is crucial for the success of dental implants in patients. | Procedure or surgery | Osseodensification in Dental Implant Surgery |
Primary outcome
Increase in Bone Density at Implant Sites Using Osseodensification Technique
Time frame: 3-6 months
The primary outcome measure is the change in bone density at the dental implant sites, measured in Hounsfield units (HU), from pre-operative to post-operative stages. The study aims to quantify the effectiveness of the osseodensification technique in enhancing bone density around the implant sites, thereby potentially improving the primary stability of dental implants. The outcome will be assessed using DentaScan CT imaging analyzed with Radiant DICOM software to compare bone density values at apical, mesial, and distal positions relative to each implant site before and after the surgical intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 39560860Vaddamanu SK, Saini RS, Vyas R, Kanji MA, Alshadidi AAF, Hafedh S, Cicciu M, Minervini G. A comparative study on bone density before and after implant placement using osseodensification technique: a clinical evaluation. Int J Implant Dent. 2024 Nov 19;10(1):56. doi: 10.1186/s40729-024-00565-8.
- Individual participant dataSharing planned: No. The study aims to share specific individual participant data related to the osseodensification technique's effect on bone density around dental implant sites. Data to be shared includes pre-operative and post-operative bone density measurements at specified implant sites, measured in Hounsfield units, and statistical analyses comparing these measurements. The data will be anonymized to protect participant confidentiality and shared with researchers who provide a methodologically sound proposal for purposes of advancing knowledge in dental implant stability and bone density impacts. Data will be available upon request following publication of the study results, subject to approval by the study's ethical review board and under a data-sharing agreement that specifies data use, security requirements, and data destruction upon project completion.
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 Osseodensification in people with Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique, run by King Khalid 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 1 inclusion and 2 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 15 Mar 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 Sunil Kumar, MDS (+966595220377, snu@kku.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Bone Density at Implant Sites Using Osseodensification Technique (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268639, which also lists 1 linked publication.
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 15 Mar 2024.