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NCT Number: NCT07459075

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baghdad University

Baghdad, Iraq

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Bone density

    Time frame: follow up after 20 weeks after maxillary sinus augmentation

  2. Histomorphometrical analysis of bone biopsy

    Time frame: 20 weeks after augmentation

    taken bone core biopsy from the planned implant placement

  3. Osteopontin Analysis from bone core biopsy

    Time frame: 20 weeks after augmentation

Secondary outcomes

  1. primary stability of implant

    Time frame: 20 weeks after augmentation

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

009647804305996

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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