Implant Site ReactionNCT06446687
Radiographic Assessment of Bone Gain Following Sinus Lifting With Simultaneous Implant Placement Using Crestal Approach With Membrane Control Technique for Bone Augmentation of Atrophied Maxillary Posterior Ridge
A study testing Dental implant with sinus lifting. in people with Implant Site Reaction and Maxillary Deficiency, run by Cairo University.
Trial summary
This study aims to evaluate the quantity and quality of the native and the newly bone around dental implants that's simultaneously installed with sinus lifting Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction, Maxillary Deficiency
- What is being tested?
- Dental implant with sinus lifting.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Feb 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients required dental implant treatment in the posterior maxilla, in the premolar and molar regions ( both sexes).
- Residual bone height 4-8mm in the estimated implant positions.
- The bone width of the alveolar ridge is at least 5mm in estimated implant positions.
- The edentulous ridges are covered with optimal thickness of mucoperiosteum.
Who cannot join
- Patients with a systemically diseases or inflammation whether local or generalized.
- Patients with bleeding disorders.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Poor oral hygiene and motivation.
- Pregnant or nursing.
- Severe bruxism or clenching.
- Active infection or severe inflammation in the area intended for implant placement.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
About this study
This study aims to evaluate the quantity and quality of the native and the newly bone around dental implants that's simultaneously installed with sinus lifting
- Conditions
- Implant Site Reaction, Maxillary Deficiency
- Being tested
- Dental implant with sinus lifting.
- Keywords
- Closed Sinus lifting, Bone Gain
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant with sinus lifting.Procedure or surgery
Surgery will be performed under local infiltration anaesthesia. Flap will be done. For maxillary sinus lifting by using Crestal approach with Membrane Control Technique by Wang (Wang, 2017) will be employed. After reflecting on the flap, Magic Split will be used to confirm bone quality clinically. This will be followed by site preparation using Magic Marking Drill. Bone drilling will then be performed by Magic Drill shorter by 2 mm from the sinus floor. This will be followed by sinus lifting by using Magic Sinus Lifter (MSL). The 3mm space of the apex of the Sinus Lifter instrument enables direct control of the bone-block and consequently the membrane, which is connected to the bone-block. the fixture will be installed in the conventional method. Then cover the fixture with the cover screw. The flap will be sutured. An immediate CBCT will be requested to ensure the implant is in its proper position.
| Study group | Role | What they receive |
|---|---|---|
| Sinus Lifting by Using Crestal approach with membrane control technique. | Experimental | Sinus Lifting with simultaneously implant placement. Receives: Procedure: Dental implant with sinus lifting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cone beam computed tomography (CBCT) bone height formation around dental implants
Calculate bone height and formation around dental implants.
Measured: Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.
Secondary outcomes (1)
Cone beam computed tomography (CBCT) density formation around dental implants
Calculate bone density formation around dental implants.
Measured: Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Hadi Homoud Radi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446687
- Sponsor's protocol ID
- 99522504
- Status last verified
- Jun 2024
- First submitted
- 13 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Assessment of Bone Gain Following Sinus Lifting With Simultaneous Implant Placement Using Crestal Approach With Membrane Control Technique for Bone Augmentation of Atrophied Maxillary Posterior Ridge
- ClinicalTrials.gov ID
- NCT06446687
- Acronym / sponsor ID
- 99522504
- Conditions
- Implant Site Reaction, Maxillary Deficiency
- Keywords
- Closed Sinus lifting, Bone Gain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 6 Jun 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.
This study aims to evaluate the quantity and quality of the native and the newly bone around dental implants that's simultaneously installed with sinus lifting
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinus Lifting by Using Crestal approach with membrane control technique. | Experimental | Procedure: Dental implant with sinus lifting.Sinus Lifting with simultaneously implant placement. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients required dental implant treatment in the posterior maxilla, in the premolar and molar regions ( both sexes).
- Residual bone height 4-8mm in the estimated implant positions.
- The bone width of the alveolar ridge is at least 5mm in estimated implant positions.
- The edentulous ridges are covered with optimal thickness of mucoperiosteum.
Key exclusion criteria (8 listed)
- Patients with a systemically diseases or inflammation whether local or generalized.
- Patients with bleeding disorders.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Poor oral hygiene and motivation.
- Pregnant or nursing.
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 |
|---|---|---|
| Dental implant with sinus lifting.Surgery will be performed under local infiltration anaesthesia. Flap will be done. For maxillary sinus lifting by using Crestal approach with Membrane Control Technique by Wang (Wang, 2017) will be employed. After reflecting on the flap, Magic Split will be used to confirm bone quality clinically. This will be followed by site preparation using Magic Marking Drill. Bone drilling will then be performed by Magic Drill shorter by 2 mm from the sinus floor. This will be followed by sinus lifting by using Magic Sinus Lifter (MSL). The 3mm space of the apex of the Sinus Lifter instrument enables direct control of the bone-block and consequently the membrane, which is connected to the bone-block. the fixture will be installed in the conventional method. Then cover the fixture with the cover screw. The flap will be sutured. An immediate CBCT will be requested to ensure the implant is in its proper position. | Procedure or surgery | Sinus Lifting by Using Crestal approach with membrane control technique. |
Primary outcome
Cone beam computed tomography (CBCT) bone height formation around dental implants
Time frame: Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.
Calculate bone height and formation around dental implants.
1 secondary outcome
Cone beam computed tomography (CBCT) density formation around dental implants
Time frame: Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant with sinus lifting. in people with Implant Site Reaction and Maxillary Deficiency, run by Cairo 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 4 inclusion and 8 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 6 Jun 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?
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?
Cone beam computed tomography (CBCT) bone height formation around dental implants (time frame: Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.). 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 6 Jun 2024.