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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Baghdad University
  Baghdad, Iraq Recruiting

Study contacts

• Study coordinator: Mohanad Ali Ali Shabat, Msc,PhD student in Oral surgey
• Email: mohanadshabat@gmail.com
• Phone: 009647804305996

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.