RecruitingPhase 4

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

Iraq30 participantsStarted 2025-05-01

Plain-language 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. 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Bone density

Timeframe: follow up after 20 weeks after maxillary sinus augmentation

Histomorphometrical analysis of bone biopsy

Timeframe: 20 weeks after augmentation

Osteopontin Analysis from bone core biopsy

Timeframe: 20 weeks after augmentation

Trial details

NCT IDNCT07459075

SponsorUniversity of Baghdad

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

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

009647804305996 mohanadshabat@gmail.com