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

NCT07459075 | Recruiting Phase 4

• 2 other identifiers: 1026125Research Ethics Committee
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.Evaluation of the bone density at the planned implants sites using cone beam computed tomography (CBCT).
2. 2.Histomorphometry examination of maxillary sinus bone to measure (bone trabeculae, connective tissue, osteoblast, osteocyte) after healing 4 months after augmentation.
3. 3.Osteopontin as biomarker analysis for bone regeneration and osteoblast activity.
4. 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.

Conditions

Maxillary Sinus Augmentation

Keywords

bone regeneration; bone grafts; orthopaedics; dental implant, PTH.

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• primary stability of implant

  20 weeks after augmentation

Study Arms (2)

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

Interventions

Maxillary sinus augmentation PROCEDURE

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

group I maxillary sinus augmenation with xenograft and PTH; group II maxillary sinus augmenation with xenograft alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Baghdad University

Baghdad, Iraq

RECRUITING

MeSH Terms

Interventions

Sinus Floor Augmentation

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Bone Transplantation; Orthopedic Procedures; Dentistry

Central Study Contacts

Mohanad Ali Ali Shabat, Msc,PhD student in Oral surgey

CONTACT

009647804305996; mohanadshabat@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr in Oral and Maxillofacial Surgery

Model Details: 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

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 9, 2026
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)