Menu
Recruiting NCT07459075

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

Phase IV Interventional Maxillary Sinus Augmentation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Maxillary sinus augmentation.
Who it may be relevant to
Registry conditions: Maxillary Sinus Augmentation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iraq
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Bone density [Time frame: follow up after 20 weeks after maxillary sinus augmentation]
  • Histomorphometrical analysis of bone biopsy [Time frame: 20 weeks after augmentation]
  • Osteopontin Analysis from bone core biopsy [Time frame: 20 weeks after augmentation]
Secondary outcome measures (1)
  • primary stability of implant [Time frame: 20 weeks after augmentation]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Iraq · 1 center
  • Baghdad University — Baghdad

Identifiers

NCT: NCT07459075 · 1026125 · Research Ethics Committee

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗