Maxillary Sinus AugmentationPhase 4NCT07459075
Radiographical, Histomorphometrical and Biomarker Analysis After Maxillary Sinus Augmentation Utilizing Xenograft Particulate Bone Graft Mixed With Parathyroid Hormone
A Phase 4 study testing Maxillary sinus augmentation in people with Maxillary Sinus Augmentation, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study aimed the to investigate the beneficial effect of combining PTH with bovine-derived bone graft bone in maxillary sinus augmentation. There is limited information available about the effect of PTH on maxillary sinus augmentation to achieve a clear understanding of PTH's efficacy in bone regeneration and bone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Sinus Augmentation
- What is being tested?
- Maxillary sinus augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 1 May 2025to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Healthy individuals without any systemic disease/local pathological lesion at the sinus zone that compromise the bone healing potential.
- Fair to good oral hygiene.
- Patient's age ≥ 18 years.
- The RBH was 3 mm or less. Atrophic edentulous posterior maxillary ridge (missing tooth or teeth in the sinus zone), with adequate ridge width (≥ 5 mm) to accommodate an average DI diameter and to gain primary implant stability.
- Healed planned implant insertion site.
Who cannot join
- Medically compromised patients with any of the following conditions that could interfere with normal healing potential or osseointegration such as uncontrolled diabetes mellitus, currently on chemotherapy, corticosteroid or bisphosphonate, radiotherapy of the head and neck in the past 2 years, bleeding disorders, ongoing pregnancy, thyroid hormones problems and psychiatric disorders.
- The RBH ˃ 3 mm.
- Thickness of the SM ˃ 5 mm.
- Maxillary sinusitis (acute and chronic) or any other pathologies in the MS.
- Previous MS surgery.
- Heavy smoking ˃ 20 cigarettes daily and/or alcohol abuse.
- Parafunctional habits such as severe bruxism and clenching.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohanad Ali Ali Shabat, Msc,PhD student in Oral surgey contact
About this study
Official title: Radiographical, Histomorphometrical and Biomarker Analysis After Maxillary Sinus Augmentation Utilizing Xenograft Particulate Bone Graft Mixed With Parathyroid Hormone: A Randomized Controlled Study
This study aimed the to investigate the beneficial effect of combining PTH with bovine-derived bone graft bone in maxillary sinus augmentation.
There is limited information available about the effect of PTH on maxillary sinus augmentation to achieve a clear understanding of PTH's efficacy in bone regeneration and bone remodelling through radiological, clinical, biomarker, histological and histomorphometric assessment .
Read more
Objectives
- Evaluation of the bone density at the planned implants sites using cone beam computed tomography (CBCT).
- Histomorphometry examination of maxillary sinus bone to measure (bone trabeculae, connective tissue, osteoblast, osteocyte) after healing 4 months after augmentation.
- Osteopontin as biomarker analysis for bone regeneration and osteoblast activity.
- Evaluate the primary stability of implant in upper posterior area filled with PTH (1 34) and bovine-derived bone graft compared to bovine-derived bone graft alone.
- Conditions
- Maxillary Sinus Augmentation
- Being tested
- Maxillary sinus augmentation
- Keywords
- bone regeneration; bone grafts; orthopaedics; dental implant, PTH.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary sinus augmentationProcedure or surgery
Intervention 1 - Control Group
Name of Intervention: Bone graft only
Type: Procedure / Biological
Description: Maxillary sinus augmentation using bone graft alone
Intervention 2 - Experimental Group
Name of Intervention: Bone graft + PTH
Type: Procedure / Drug (PTH)
Description: Maxillary sinus augmentation using bone graft combined with parathyroid hormone (PTH
| Study group | Role | What they receive |
|---|---|---|
| group I maxillary sinus augmenation with xenograft and PTH | Experimental | Not described Receives: Procedure: Maxillary sinus augmentation |
| group II maxillary sinus augmenation with xenograft alone | Experimental | Not described Receives: Procedure: Maxillary sinus augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Measured: follow up after 20 weeks after maxillary sinus augmentation
Histomorphometrical analysis of bone biopsy
taken bone core biopsy from the planned implant placement
Measured: 20 weeks after augmentation
Osteopontin Analysis from bone core biopsy
Measured: 20 weeks after augmentation
Secondary outcomes (1)
primary stability of implant
Measured: 20 weeks after augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 May 2025
- Primary completionMay 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus AugmentationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated into two parallel groups. The intervention group will receive xenograft bone mixed with parathyroid hormone (PTH) during bone grafting, while the control group will receive xenograft bone alone in maxillary sinus augmentation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
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
- NCT07459075
- Sponsor's protocol ID
- 1026125
- Other IDs
- Research Ethics Committee
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographical, Histomorphometrical and Biomarker Analysis After Maxillary Sinus Augmentation Utilizing Xenograft Particulate Bone Graft Mixed With Parathyroid Hormone: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07459075
- Acronym / sponsor ID
- 1026125
- Conditions
- Maxillary Sinus Augmentation
- Keywords
- bone regeneration; bone grafts; orthopaedics; dental implant, PTH.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Mar 2026 (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 aimed the to investigate the beneficial effect of combining PTH with bovine-derived bone graft bone in maxillary sinus augmentation.
There is limited information available about the effect of PTH on maxillary sinus augmentation to achieve a clear understanding of PTH's efficacy in bone regeneration and bone remodelling through radiological, clinical, biomarker, histological and histomorphometric assessment .
Objectives
- Evaluation of the bone density at the planned implants sites using cone beam computed tomography (CBCT).
- Histomorphometry examination of maxillary sinus bone to measure (bone trabeculae, connective tissue, osteoblast, osteocyte) after healing 4 months after augmentation.
- Osteopontin as biomarker analysis for bone regeneration and osteoblast activity.
- Evaluate the primary stability of implant in upper posterior area filled with PTH (1 34) and bovine-derived bone graft compared to bovine-derived bone graft alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be allocated into two parallel groups. The intervention group will receive xenograft bone mixed with parathyroid hormone (PTH) during bone grafting, while the control group will receive xenograft bone alone in maxillary sinus augmentation
| Arm | Type | Receives |
|---|---|---|
| group I maxillary sinus augmenation with xenograft and PTH | Experimental | Procedure: Maxillary sinus augmentation |
| group II maxillary sinus augmenation with xenograft alone | Experimental | Procedure: Maxillary sinus augmentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy individuals without any systemic disease/local pathological lesion at the sinus zone that compromise the bone healing potential.
- Fair to good oral hygiene.
- Patient's age ≥ 18 years.
- The RBH was 3 mm or less. Atrophic edentulous posterior maxillary ridge (missing tooth or teeth in the sinus zone), with adequate ridge width (≥ 5 mm) to accommodate an average DI diameter and to gain primary implant stability.
- Healed planned implant insertion site.
Key exclusion criteria (7 listed)
- Medically compromised patients with any of the following conditions that could interfere with normal healing potential or osseointegration such as uncontrolled diabetes mellitus, currently on chemotherapy, corticosteroid or bisphosphonate, radiotherapy of the head and neck in the past 2 years, bleeding disorders, ongoing pregnancy, thyroid hormones problems and psychiatric disorders.
- The RBH ˃ 3 mm.
- Thickness of the SM ˃ 5 mm.
- Maxillary sinusitis (acute and chronic) or any other pathologies in the MS.
- Previous MS surgery.
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 |
|---|---|---|
| Maxillary sinus augmentationIntervention 1 - Control Group Name of Intervention: Bone graft only Type: Procedure / Biological Description: Maxillary sinus augmentation using bone graft alone Intervention 2 - Experimental Group Name of Intervention: Bone graft + PTH Type: Procedure / Drug (PTH) Description: Maxillary sinus augmentation using bone graft combined with parathyroid hormone (PTH | Procedure or surgery | group I maxillary sinus augmenation with xenograft and PTH, group II maxillary sinus augmenation with xenograft alone |
Primary outcome
Bone density
Time frame: follow up after 20 weeks after maxillary sinus augmentation
Histomorphometrical analysis of bone biopsy
Time frame: 20 weeks after augmentation
taken bone core biopsy from the planned implant placement
Osteopontin Analysis from bone core biopsy
Time frame: 20 weeks after augmentation
1 secondary outcome
primary stability of implant
Time frame: 20 weeks after augmentation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Yes
Related trials for Maxillary Sinus Augmentation
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Enrolling by invitationPhase 1
Smart Scaffolds, Stronger Smiles Smarter Healing: AI-Boosted Multiphasic Scaffold Design for PDL Regeneration
Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation
Not yet recruitingEarly Phase 1
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
Partially Edentulous Maxilla
Active, not recruiting
Endoscopic-Assisted Versus Conventional Crestal Sinus Lift
Bone Defects
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.
Mohanad Ali Ali Shabat, Msc,PhD student in Oral surgey contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Maxillary sinus augmentation in people with Maxillary Sinus Augmentation, 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohanad Ali Ali Shabat, Msc,PhD student in Oral surgey (009647804305996, mohanadshabat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density (time frame: follow up after 20 weeks after maxillary sinus augmentation). The study lists 3 primary outcomes in all. 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 9 Mar 2026.