Radiographical, Histomorphometrical and Biomarker Analysis After Maxillary Sinus Augmentation Utilizing Xenograft Particulate Bone Graft Mixed With Parathyroid Hormone

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 .

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.

Study Overview

• Status: Recruiting
• Conditions: Maxillary Sinus Augmentation
• Intervention / Treatment: Procedure: Maxillary sinus augmentation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

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

Study Locations

• Iraq
  • Baghdad, Iraq
    • Recruiting
    • Baghdad University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group I maxillary sinus augmenation with xenograft and PTH	Procedure: Maxillary sinus augmentation; 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
Experimental: group II maxillary sinus augmenation with xenograft alone	Procedure: Maxillary sinus augmentation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density		follow up after 20 weeks after maxillary sinus augmentation
Histomorphometrical analysis of bone biopsy	taken bone core biopsy from the planned implant placement	20 weeks after augmentation
Osteopontin Analysis from bone core biopsy		20 weeks after augmentation

Secondary Outcome Measures

Outcome Measure	Time Frame
primary stability of implant	20 weeks after augmentation

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: bone regeneration; bone grafts; orthopaedics; dental implant, PTH.
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Orthopedic Procedures; Dentistry; Oral Surgical Procedures; Bone Transplantation; Sinus Floor Augmentation
• Other Study ID Numbers: 1026125; Research Ethics Committee (Other Identifier: The Research Ethics Committee of the College of Dentistry, University of Baghdad. Project No. 1026125)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No