Parathyroid hormone added to bovine bone graft for upper jaw sinus augmentation

Radiographical, Histomorphometrical and Biomarker Analysis After Maxillary Sinus Augmentation Utilizing Xenograft Particulate Bone Graft Mixed With Parathyroid Hormone: A Randomized Controlled Study

This will test whether adding parathyroid hormone to a bovine bone graft helps adults needing maxillary sinus augmentation get stronger bone for dental implants.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Baghdad (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Baghdad)
• Trial ID: NCT07459075 on ClinicalTrials.gov

What this trial studies

This interventional Phase 4 protocol enrolls adults needing maxillary sinus augmentation before dental implant placement and compares bovine-derived xenograft alone versus the same graft mixed with parathyroid hormone (PTH 1-34). Participants undergo sinus lift surgery with the assigned graft material and are followed for four months before implant placement. Outcomes include cone beam CT measurement of bone density at planned implant sites, histomorphometric analysis of biopsy samples for trabecular bone and cellular markers, measurement of osteopontin as a biomarker, and assessment of primary implant stability. The trial is conducted at the University of Baghdad and uses radiographic, histological, biomarker and clinical measures to compare bone regeneration and remodeling between groups.

Who should consider this trial

Good fit: Adults (≥18) with healed posterior maxillary sites, residual bone height ≤3 mm, adequate ridge width (≥5 mm), good oral hygiene, and no systemic conditions that impair healing.

Not a fit: People with residual bone height >3 mm, sinus membrane thickness >5 mm, active maxillary sinusitis, uncontrolled systemic illness, or current use of interfering medications (bisphosphonates, corticosteroids, recent chemo/radiation) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could speed or improve bone regeneration in the sinus and increase primary implant stability, reducing the risk of implant failure.

How similar studies have performed: Parathyroid hormone shows bone-building effects in animal studies and limited human bone-healing reports, but clinical evidence specifically for maxillary sinus augmentation is sparse.

Eligibility criteria

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.

Where this trial is running

Baghdad

• Baghdad University — Baghdad, Iraq (Recruiting)

Study contacts

• Study coordinator: Mohanad Ali Ali Shabat, Msc,PhD student in Oral surgey

Conditions Maxillary Sinus Augmentation; bone regeneration; bone grafts; orthopaedics; dental implant, PTH.