About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Maxillary sinus augmentation
Procedure/SurgeryIntervention 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
Treatment groups
Trial outcomes
Primary outcomes
Bone density
Histomorphometrical analysis of bone biopsy
taken bone core biopsy from the planned implant placement
Osteopontin Analysis from bone core biopsy
Secondary outcomes
primary stability of implant
Sponsors and contacts
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