Bone Density, LowRCTNCT06285903
Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing
A study testing internal sinus lift surgery in people with Bone Density, Low, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Successful osseointegration considered the cornerstone in implant stability which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Read more about this study
- Who is it for?
- Ages 35 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Density, Low
- What is being tested?
- internal sinus lift surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2022to 30 Dec 2023
- 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 35 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- free of systemic disease bone height at the site of the implant is ≤ 6 mm. have good oral hygiene.
- -
Who cannot join
- systemic diseases active periodontal disease , limited mouth-opening ability maxillary sinus disease or previous sinus surgery were also excluded smokers pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing: (a Randomized Clinical Trial)
Successful osseointegration considered the cornerstone in implant stability which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone sur-rounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain
Read the detailed description
Objectives: This study was directed to compare the outcomes of internal sinus lifting between osseodensification approach and piezoelectric surgery approach on the primary stability and osseointegration of dental implant.
Background data: Successful osseointegration considered the cornerstone in implant sta-bility which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone surrounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain.
Materials and Methods: A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to determine implant stability by recording the values of implant stability quotient (ISQ) immediately after implant placement and after 3 months. CBCT was performed before, after 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 , 12 months via CBCT.
- Conditions
- Bone Density, Low
- Being tested
- internal sinus lift surgery
- Keywords
- Dental implant, Osseointegration, primary implant stability, , internal sinus lifting, osseodensification,, piezoelectric
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal sinus lift surgeryProcedure or surgery
surgery approach
| Study group | Role | What they receive |
|---|---|---|
| Group Densah Bur | Experimental | patients received dental implant using osseodensification via Densah bur Receives: Procedure: internal sinus lift surgery |
| Group piezoelectric | Experimental | patients received dental implant using hydrodynamic piezoelectric sinus lifting Receives: Procedure: internal sinus lift surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability using the Osstell device by percentage
Primary implant stability (ISQ)
Measured: baseline ,3 months
Secondary outcomes (1)
Modified sulcus bleeding index,Peri-implant pocket depth (PPD)by mm
Clinical evaluation
Measured: 3,6,9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start2 Sep 2022
- Primary completion1 Dec 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Density, LowStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to de-termine implant stability by recording the values of implant stability quotient (ISQ) im-mediately after implant placement and after 3 months. CBCT was performed before, af-ter 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 months and after 12 months via CBCT.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaymaa Hussein Rafat Kotb, Al-Azhar University
- Investigators
- Ibrahim Hammad Ibrahim, lecturer, Study director, Al-Azhar UniversityKhalid s Hassan, Dean of Badr University, Study chair, Faculty of Dentistry ,Badr university ,Assuit branch ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285903
- Sponsor's protocol ID
- AUAREC20220002-11
- Acronym
- RCT
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Comparing the Hydrodynamic Piezoelectric Technique with Osseodensification for the Assessment of Internal Sinus Iift-ing: (a Randomized Clinical Trial)
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing: (a Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06285903
- Acronym / sponsor ID
- RCT / AUAREC20220002-11
- Conditions
- Bone Density, Low
- Keywords
- Dental implant, Osseointegration, primary implant stability, , internal sinus lifting, osseodensification,, piezoelectric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 29 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.
Successful osseointegration considered the cornerstone in implant stability which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone sur-rounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain
Detailed description
Objectives: This study was directed to compare the outcomes of internal sinus lifting between osseodensification approach and piezoelectric surgery approach on the primary stability and osseointegration of dental implant.
Background data: Successful osseointegration considered the cornerstone in implant sta-bility which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone surrounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain.
Materials and Methods: A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to determine implant stability by recording the values of implant stability quotient (ISQ) immediately after implant placement and after 3 months. CBCT was performed before, after 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 , 12 months via CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to de-termine implant stability by recording the values of implant stability quotient (ISQ) im-mediately after implant placement and after 3 months. CBCT was performed before, af-ter 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 months and after 12 months via CBCT.
| Arm | Type | Receives |
|---|---|---|
| Group Densah Bur | Experimental | Procedure: internal sinus lift surgerypatients received dental implant using osseodensification via Densah bur |
| Group piezoelectric | Experimental | Procedure: internal sinus lift surgerypatients received dental implant using hydrodynamic piezoelectric sinus lifting |
Who may qualify
- Ages
- 35 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- free of systemic disease bone height at the site of the implant is ≤ 6 mm. have good oral hygiene.
- -
Key exclusion criteria (1 listed)
- systemic diseases active periodontal disease , limited mouth-opening ability maxillary sinus disease or previous sinus surgery were also excluded smokers pregnant
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 |
|---|---|---|
| internal sinus lift surgerysurgery approach | Procedure or surgery | Group Densah Bur, Group piezoelectric |
Primary outcome
Implant stability using the Osstell device by percentage
Time frame: baseline ,3 months
Primary implant stability (ISQ)
1 secondary outcome
Modified sulcus bleeding index,Peri-implant pocket depth (PPD)by mm
Time frame: 3,6,9 months
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 28 Mar 2024.
- orchidLink provided by the sponsor.
- web of scienceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Comparing the Hydrodynamic Piezoelectric Technique with Osseodensification for the Assessment of Internal Sinus Iift-ing: (a Randomized Clinical Trial)
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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.
Ibrahim Hammad Ibrahim, lecturer study director
Al-Azhar University
Khalid s Hassan, Dean of Badr University study chair
Faculty of Dentistry ,Badr university ,Assuit branch ,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internal sinus lift surgery in people with Bone Density, Low, 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 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: finished, as of the sponsor's last update on 28 Mar 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.
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 stability using the Osstell device by percentage (time frame: baseline ,3 months). 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 28 Mar 2024.