Radiographical, Histomorphometrical and Biomarker Analysis After Maxillary Sinus Augmentation Utilizing Xenograft Particulate Bone Graft Mixed With Parathyroid Hormone: A Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- University of Baghdad
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Bone density
Study Overview
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
- Evaluation of the bone density at the planned implants sites using cone beam computed tomography (CBCT).
- Histomorphometry examination of maxillary sinus bone to measure (bone trabeculae, connective tissue, osteoblast, osteocyte) after healing 4 months after augmentation.
- Osteopontin as biomarker analysis for bone regeneration and osteoblast activity.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
group I maxillary sinus augmenation with xenograft and PTH
Intervention: Maxillary sinus augmentation (Procedure)
group II maxillary sinus augmenation with xenograft alone
Intervention: Maxillary sinus augmentation (Procedure)
Outcomes
Primary Outcomes
Bone density
Time Frame: follow up after 20 weeks after maxillary sinus augmentation
Histomorphometrical analysis of bone biopsy
Time Frame: 20 weeks after augmentation
taken bone core biopsy from the planned implant placement
Osteopontin Analysis from bone core biopsy
Time Frame: 20 weeks after augmentation
Secondary Outcomes
- primary stability of implant(20 weeks after augmentation)
Investigators
NIBRAS HAMDAN CHASIB BAIDHANI
Prof. Dr in Oral and Maxillofacial Surgery
University of Baghdad