Implant TherapyPhase 2NCT06689969
Effect of Osseodensification on the Peri-implant Condition
A Phase 2 study testing conventional implant placement method and Osseodensification to implant placement using densah bur kit in people with Implant Therapy, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the effects of osseodensification vs. traditional implant site preparation clinically , radiographically, bio-chemically. in patients of both sexes, ages 25 to 45, who had bilaterally missed maxillary teeth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implant Therapy
- What is being tested?
- conventional implant placement method and Osseodensification to implant placement using densah bur kit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2022to 15 Mar 2024
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients were free from any systemic diseases
- Individuals above age of 18 who have thin ridges and missing bilateral maxillary posterior teeth
Who cannot join
- Severe skeletal discrepancy.
- Para functional habits.
- Patients who had already received or lost implants in the potential implantation site.
- Smoker patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dental medicine, Al-Azhar University (Assiut branch)
Asyut, Asyut Governorate, 71524
About this study
Official title: Evaluation of the Effect of Osseodensification on the Peri-implant Condition
The goal of this clinical trial is to evaluate the effects of osseodensification vs. traditional implant site preparation clinically , radiographically, bio-chemically. in patients of both sexes, ages 25 to 45, who had bilaterally missed maxillary teeth. The main questions it aims to answer are :which technique was the better results give at implant placement? Researchers will compare Osseodensification maneuver in implant placement to see if implant stability increased also peri-implant tissue accurately formed or the same in traditional implant site preparation. Participants will receiving dental implants in narrow maxillary posterior ridge via small diameter implant in conventional method in first entity while in second entity implant by osseodensification technique using densah bur.
- Conditions
- Implant Therapy
- Being tested
- conventional implant placement method, Osseodensification to implant placement using densah bur kit
- Keywords
- Osseodensification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional implant placement methodProcedure or surgery
Site marking was the first step in preparing the place for implantation. Subsequently, using a high speed surgical handpiece and a surgical motor, a pilot drill was revolved at 1200 RPM in a clockwise rotation to the desired depth, creating a 1.5 mm first pilot osteotomy. An X-ray was obtained using paralleling pins to validate the angle between the surrounding teeth and the implants. Eventually the implant's precise placement was established. To prepare the osteotomy site to the desired diameter, drills are used sequentially at 1200 RPM in a clockwise motion. Gradually bigger drill diameters were used for incremental drilling. Based on the diameter of the desired implant, bur sizes were utilized in ascending order
Osseodensification to implant placement using densah bur kitProcedure or surgery
Beginning with site marking, the area was prepared for implantation. A high speed surgical handpiece and a surgical motor (surgic pro® NSK, Japan) were then used to construct a 1.5 mm initial pilot osteotomy using a pilot drill spun at 1200 RPM in a clockwise rotation to the desired depth. In order to verify the angle between the surrounding teeth and the implants, paralleling pins were used to capture an X-ray.
After it was determined that the implant was in the proper location, OD was used to extend the osteotomy using a Densah® Bur VT1525 2.0-mm (VersahTM, LLC, USA) in non-cutting anticlockwise rotation at 1200 RPM (Densifying Mode). The osteotomy was expanded to the desired diameter by repeatedly using a DensahTM Bur operating in a non-cutting anticlockwise (CCW) direction at 1200 RPM (Densifying Mode). Gradually increasing drill diameters were used for incremental drilling. Based on the diameter of the desired implant, bur sizes (diameters) were utilised in ascending order
| Study group | Role | What they receive |
|---|---|---|
| patients with narrow ridge received small diameter implant in conventional method. | Active comparator | Not described Receives: Procedure: conventional implant placement method |
| patients with narrow ridge received implant by OD technique using densah bur. | Active comparator | Not described Receives: Procedure: Osseodensification to implant placement using densah bur kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant primary stability
Osstell® Mentor magnetic resonance instrument used to measure primary stability
Measured: A single time point (once immediately after implant placement)
Bone density
Measuring of bone density (BD) through using the image J analysis software application
Measured: From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)
Assessment of interleukin -6
Measured: From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)
Assessment of Vascular endothelial growth factor
Measured: [Time Frame: From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)]
Secondary outcomes (1)
Peri-implant probing depth
Measured: From enrollment to the end of treatment at 24 weeks" (at the beginning, three-, and six-months following implant insertion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start3 Jan 2022
- Primary completion29 Oct 2023
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Implant TherapyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asem Mohammed Kamel Ali, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689969
- Sponsor's protocol ID
- Osseodensification in implant
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strietzel FP, Nowak M, Kuchler I, Friedmann A. Peri-implant alveolar bone loss with respect to bone quality after use of the osteotome technique: results of a retrospective study. Clin Oral Implants Res. 2002 Oct;13(5):508-13. doi: 10.1034/j.1600-0501.2002.130510.x.
PubMed 12453128Johnson RB, Serio FG, Dai X. Vascular endothelial growth factors and progression of periodontal diseases. J Periodontol. 1999 Aug;70(8):848-52. doi: 10.1902/jop.1999.70.8.848.
PubMed 10476891Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.
PubMed 26584202
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Osseodensification on the Peri-implant Condition
- ClinicalTrials.gov ID
- NCT06689969
- Acronym / sponsor ID
- Osseodensification in implant
- Conditions
- Implant Therapy
- Keywords
- Osseodensification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 29 Oct 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 15 Nov 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 goal of this clinical trial is to evaluate the effects of osseodensification vs. traditional implant site preparation clinically , radiographically, bio-chemically. in patients of both sexes, ages 25 to 45, who had bilaterally missed maxillary teeth. The main questions it aims to answer are :which technique was the better results give at implant placement? Researchers will compare Osseodensification maneuver in implant placement to see if implant stability increased also peri-implant tissue accurately formed or the same in traditional implant site preparation. Participants will receiving dental implants in narrow maxillary posterior ridge via small diameter implant in conventional method in first entity while in second entity implant by osseodensification technique using densah bur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with narrow ridge received small diameter implant in conventional method. | Active comparator | Procedure: conventional implant placement method |
| patients with narrow ridge received implant by OD technique using densah bur. | Active comparator | Procedure: Osseodensification to implant placement using densah bur kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients were free from any systemic diseases
- Individuals above age of 18 who have thin ridges and missing bilateral maxillary posterior teeth
Key exclusion criteria (4 listed)
- Severe skeletal discrepancy.
- Para functional habits.
- Patients who had already received or lost implants in the potential implantation site.
- Smoker patients.
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 implant placement methodSite marking was the first step in preparing the place for implantation. Subsequently, using a high speed surgical handpiece and a surgical motor, a pilot drill was revolved at 1200 RPM in a clockwise rotation to the desired depth, creating a 1.5 mm first pilot osteotomy. An X-ray was obtained using paralleling pins to validate the angle between the surrounding teeth and the implants. Eventually the implant's precise placement was established. To prepare the osteotomy site to the desired diameter, drills are used sequentially at 1200 RPM in a clockwise motion. Gradually bigger drill diameters were used for incremental drilling. Based on the diameter of the desired implant, bur sizes were utilized in ascending order | Procedure or surgery | patients with narrow ridge received small diameter implant in conventional method. |
| Osseodensification to implant placement using densah bur kitBeginning with site marking, the area was prepared for implantation. A high speed surgical handpiece and a surgical motor (surgic pro® NSK, Japan) were then used to construct a 1.5 mm initial pilot osteotomy using a pilot drill spun at 1200 RPM in a clockwise rotation to the desired depth. In order to verify the angle between the surrounding teeth and the implants, paralleling pins were used to capture an X-ray. After it was determined that the implant was in the proper location, OD was used to extend the osteotomy using a Densah® Bur VT1525 2.0-mm (VersahTM, LLC, USA) in non-cutting anticlockwise rotation at 1200 RPM (Densifying Mode). The osteotomy was expanded to the desired diameter by repeatedly using a DensahTM Bur operating in a non-cutting anticlockwise (CCW) direction at 1200 RPM (Densifying Mode). Gradually increasing drill diameters were used for incremental drilling. Based on the diameter of the desired implant, bur sizes (diameters) were utilised in ascending order | Procedure or surgery | patients with narrow ridge received implant by OD technique using densah bur. |
Primary outcome
Implant primary stability
Time frame: A single time point (once immediately after implant placement)
Osstell® Mentor magnetic resonance instrument used to measure primary stability
Bone density
Time frame: From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)
Measuring of bone density (BD) through using the image J analysis software application
Assessment of interleukin -6
Time frame: From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)
Assessment of Vascular endothelial growth factor
Time frame: [Time Frame: From enrollment to the end of treatment at 24 weeks" (at the beginning, one, three-, and six-months following implant insertion)]
1 secondary outcome
Peri-implant probing depth
Time frame: From enrollment to the end of treatment at 24 weeks" (at the beginning, three-, and six-months following implant insertion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Background: PubMed 12453128Strietzel FP, Nowak M, Kuchler I, Friedmann A. Peri-implant alveolar bone loss with respect to bone quality after use of the osteotome technique: results of a retrospective study. Clin Oral Implants Res. 2002 Oct;13(5):508-13. doi: 10.1034/j.1600-0501.2002.130510.x.
- Background: PubMed 10476891Johnson RB, Serio FG, Dai X. Vascular endothelial growth factors and progression of periodontal diseases. J Periodontol. 1999 Aug;70(8):848-52. doi: 10.1902/jop.1999.70.8.848.
- Background: PubMed 26584202Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing conventional implant placement method and Osseodensification to implant placement using densah bur kit in people with Implant Therapy, run by Al-Azhar University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 15 Nov 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Implant primary stability (time frame: A single time point (once immediately after implant placement)). The study lists 4 primary outcomes in all. 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 NCT06689969, which also lists 3 linked publications.
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 Nov 2024.