Radiographic and Histomorphometric Assessment for Maxillary Sinus Floor Elevation and Augmentation Using A Mixture of 1:1 Autogenous Bone With Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate

Official title

Radiographic and Histomorphometric Assessment for Maxillary Sinus Floor Elevation and Augmentation Using A Mixture of 1:1 Autogenous Bone With Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate: A Randomized Clinical Trial

Overview

two group of patients with atrophied posterior maxilla that need implant/s placement. one group will be subjected to maxillary sinus floor elevation using 1:1 mixture of autogenous bone and deproteinized bovine bone particulate while the other will be subjected to maxillary sinus floor elevation using deproteinized bovine bone particulate alone.

Detailed description

• Preoperative imaging using CBCT will be performed to assess the anatomy of the maxillary sinus, including the presence of septa, the thickness of the sinus membrane, and the quality and quantity of bone available for grafting and to exlude the presence of any pathosis.

Phase 1 (concerning maxillary sinus floor elevation and Graft placement):

* All surgical procedures will be performed by a single experienced oral surgeon to minimize variability. * All patients in the two groups would be operated under Local anaesthesia, a full-thickness mucoperiosteal flap originating from the midcrestal area or slightly toward the palate side would be opened. * A lateral window will be created in the maxillary bone using, The window should be large enough to allow for adequate access to the sinus membrane. * The Schneiderian membrane will be carefully elevated using a sinus elevator or similar instrument. * Once the membrane is elevated, Depending on the allocation, graft material will be placed into the sinus cavity either using A mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate. * a collagen membrane will be placed over the graft material. The membrane should be trimmed to fit the dimensions of the lateral window and secured in place using resorbable sutures or tacks if necessary. * The mucoperiosteal flap will be repositioned and secured using sutures.

Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative):

* A full thickness mucoperiosteal flap originating from the mid-crestal area or slightly towards palate side would be opened for both groups. * A core biopsy would be harvested from both groups using trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment.

The mucoperiosteal flap will be repositioned and secured using sutures

Interventions

• Procedure maxillary sinus floor elevation using Open Maxillary sinus floor elevation and Augmentation using Deproteinized Bovine Bone Particulate
  Phase 1: Grafting * after administration of Local anesthesia (articaine hydrochloride 68 mg/1.7 ml \+ adrenaline0.017 mg), full-thickness mucoperiosteal flap originating from the mid-crestal area or slightly toward the palate side would be opened. * lateral window will be created in the maxillary bone to allow for adequate access to the sinus membrane. * The membrane will be carefully elevated using a sinus elevator. * bone graft will be placed into the sinus cavity using Autogenous Bone wit
• Procedure Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate
  Phase 1: Grafting * After maxillary sinus floor elevation, Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate will be placed in the sinus cavity and secured in place using resorbable sutures or tacks if necessary. * Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative): * full thickness mucoperiosteal flap originating from the mid-crestal area or slightly towards palate side would be opened. • core biopsy would be harvested using trephin

Primary outcome measures

• Bone Height Changes [Time frame: 9 month]

Secondary outcome measures (1)

• 1. Bone Volume Changes [Time frame: 9 month]

Eligibility criteria

Inclusion criteria

• • Patients of both genders requiring implants placement in atrophied posterior maxilla with residual bone height less than 5mm .

• Patients of age older than 30 years old.
• Patients with adequate Inter-arch space.
• Patients who were willing and fully capable to comply with the study protocol.

Exclusion criteria

• • Patients suffering from any sinus pathosis

• Heavy smokers (> than 10 cigarettes a day)
• Patients with parafunctional habits
• Patients with uncontrolled systemic diseases.
• Patients with poor oral hygiene
• Patients with mental instabilities or psychic patients

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

Egypt · 1 center

• faculty of oral and dental medicine, Cairo university — Cairo

Identifiers

NCT: NCT07177495 · maxillary sinus lift

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗