Lateral Sinus LiftingEarly Phase 1NCT06810921
Lateral Sinus Augmentation Utilizing Bovine Bone Mixed with Platelet-rich Fibrin
A Early Phase 1 study testing lateral sinus lift in people with Lateral Sinus Lifting, run by University of Baghdad at 1 site in Iraq.
Trial summary
Background: In sinus augmentation procedure, graft resorption remains a major dilemma of various graft materials. Objective: To estimate the graft volume changes following lateral sinus augmentation utilizing cone beam computed tomography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lateral Sinus Lifting
- What is being tested?
- lateral sinus lift
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIraq
- Study dates
- 13 Jan 2023to 1 Aug 2024
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- requiring lateral sinus lift for implant placement
Who cannot join
- available bone permits implant placement without need for sinus lifting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateral Sinus Augmentation Utilizing Bovine Bone Mixed with Platelet-rich Fibrin: Evaluation of Graft Volume Changes Based on CBCT Imaging
Background:
In sinus augmentation procedure, graft resorption remains a major dilemma of various graft materials.
Read more
Objective:
To estimate the graft volume changes following lateral sinus augmentation utilizing cone beam computed tomography.
Methods: A total of 34 lateral sinus augmentation operations were performed and 50 dental implants were concomitantly inserted. The sinus augmentation cases were distributed randomly into 3 groups according to graft material: Group A comprised utilizing deproteinized bovine bone alone, group B using deproteinized bovine bone mixed with leukocyte and platelet-rich fibrin, and group C employing deproteinized bovine bone mixed with advanced platelet-rich fibrin. Cone-beam computed tomography was obtained 2 weeks (baseline record) and 24 weeks postoperatively for the measurement of the graft volume changes.
- Conditions
- Lateral Sinus Lifting
- Being tested
- lateral sinus lift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral sinus liftProcedure or surgery
A rectangular shaped osteotomy was performed using a low-speed surgical handpiece and round diamond bur, with copious cooled normal saline irrigation.
The Schneiderian membrane (SM) was gently elevatated using Frios Sinus Set elevators for implant placement
| Study group | Role | What they receive |
|---|---|---|
| utilizing bovine bone mixed with PRF for sinus lifting | Active comparator | Not described Receives: Procedure: lateral sinus lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of graft volume changes based on CBCT imaging
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start13 Jan 2023
- Primary completion20 Mar 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Sinus LiftingStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NIBRAS HAMDAN CHASIB BAIDHANI, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810921
- Sponsor's protocol ID
- 998125
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Sinus Augmentation Utilizing Bovine Bone Mixed with Platelet-rich Fibrin: Evaluation of Graft Volume Changes Based on CBCT Imaging
- ClinicalTrials.gov ID
- NCT06810921
- Acronym / sponsor ID
- 998125
- Conditions
- Lateral Sinus Lifting
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 6 Feb 2025 (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.
Background:
In sinus augmentation procedure, graft resorption remains a major dilemma of various graft materials.
Objective:
To estimate the graft volume changes following lateral sinus augmentation utilizing cone beam computed tomography.
Methods: A total of 34 lateral sinus augmentation operations were performed and 50 dental implants were concomitantly inserted. The sinus augmentation cases were distributed randomly into 3 groups according to graft material: Group A comprised utilizing deproteinized bovine bone alone, group B using deproteinized bovine bone mixed with leukocyte and platelet-rich fibrin, and group C employing deproteinized bovine bone mixed with advanced platelet-rich fibrin. Cone-beam computed tomography was obtained 2 weeks (baseline record) and 24 weeks postoperatively for the measurement of the graft volume changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| utilizing bovine bone mixed with PRF for sinus lifting | Active comparator | Procedure: lateral sinus lift |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- requiring lateral sinus lift for implant placement
Key exclusion criteria (1 listed)
- available bone permits implant placement without need for sinus lifting
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 |
|---|---|---|
| lateral sinus liftA rectangular shaped osteotomy was performed using a low-speed surgical handpiece and round diamond bur, with copious cooled normal saline irrigation. The Schneiderian membrane (SM) was gently elevatated using Frios Sinus Set elevators for implant placement | Procedure or surgery | utilizing bovine bone mixed with PRF for sinus lifting |
Primary outcome
Evaluation of graft volume changes based on CBCT imaging
Time frame: 24 weeks
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 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Lateral Sinus Lifting
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Guided Lateral Sinus Lifting Using Autologous Serum Albumin/Platelet-Rich Fibrin
Sinus Perforation, Dental Implant Failure Nos
Not yet recruiting
Prospective Study of Bone Augmentation With Lateral Sinus Lift and Osseointegration of Dental Implants
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The Use of Extended Platelet Rich Fibrin in Lateral Sinus Augmentation
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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 Early Phase 1 study testing lateral sinus lift in people with Lateral Sinus Lifting, run by University of Baghdad at 1 site in Iraq.
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 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 6 Feb 2025. 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 Iraq. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Evaluation of graft volume changes based on CBCT imaging (time frame: 24 weeks). 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 Feb 2025.