Radiographical, Histomorphometrical and Biomarker Analysis After Maxillary Sinus Augmentation Uti… (NCT07459075) | Clinical Trial Compass
RecruitingPhase 4
Radiographical, Histomorphometrical and Biomarker Analysis After Maxillary Sinus Augmentation Utilizing Xenograft Particulate Bone Graft Mixed With Parathyroid Hormone
Iraq30 participantsStarted 2025-05-01
Plain-language 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 remodelling through radiological, clinical, biomarker, histological and histomorphometric assessment .
Objectives
1. Evaluation of the bone density at the planned implants sites using cone beam computed tomography (CBCT).
2. Histomorphometry examination of maxillary sinus bone to measure (bone trabeculae, connective tissue, osteoblast, osteocyte) after healing 4 months after augmentation.
3. Osteopontin as biomarker analysis for bone regeneration and osteoblast activity.
4. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone density
Timeframe: follow up after 20 weeks after maxillary sinus augmentation
2
Histomorphometrical analysis of bone biopsy
Timeframe: 20 weeks after augmentation
3
Osteopontin Analysis from bone core biopsy
Timeframe: 20 weeks after augmentation
Trial details
NCT IDNCT07459075
SponsorUniversity of Baghdad
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-05
Contact for this trial
Mohanad Ali Ali Shabat, Msc,PhD student in Oral surgey