Maxillary Sinus Augmentation
Conditions
Keywords
bone regeneration; bone grafts; orthopaedics; dental implant, PTH.
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. 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
PROCEDUREMaxillary 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
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone density | follow up after 20 weeks after maxillary sinus augmentation | — |
| Histomorphometrical analysis of bone biopsy | 20 weeks after augmentation | taken bone core biopsy from the planned implant placement |
| Osteopontin Analysis from bone core biopsy | 20 weeks after augmentation | — |
Secondary
| Measure | Time frame |
|---|---|
| primary stability of implant | 20 weeks after augmentation |
Countries
Iraq
Contacts
CONTACTMohanad Ali Ali Shabat, Msc,PhD student in Oral surgey
Outcome results
None listed