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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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07177495
Enrollment
26
Registered
2025-09-17
Start date
2025-04-10
Completion date
2026-03-10
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinus Lifting

Keywords

maxillary sinus lifting, deproteinized bovine bone particulate, autogenous bone graft

Brief summary

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

PROCEDUREmaxillary 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 with Deproteinized Bovine Bone Particulate. * collagen membrane will be 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 trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment.

PROCEDUREOpen 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 trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

the trial is considered a randomized single blind clinical trial due to the following: * the participants will be blinded by the technique that will be used during the surgical procedure. * the operator will not be blinded for both techniques during the surgical procedure as the two techniques are different. * the outcome assessor cannot be blinded.

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bone Height Changes9 monthmeasuring the amount of change in the bone height using cone beam computed tomography in millimeters.

Secondary

MeasureTime frameDescription
1. Bone Volume Changes9 monthmeasuring the volumetric changes of bone using CBCT in Cm3

Other

MeasureTime frameDescription
Percentage of newly formed bone9 monthmeasuring the percentage of bone area using histomorphometric analysis of decalcified bone sections with hematoxylin and eosin stain using image analyzer computer system
Percentage of Mature Bone9 monthmeasuring the percentage of mature bone using histomorphometric analysis of decalcified bone sections with masson trichrome stain using image analyzer computer system.

Countries

Egypt

Contacts

Primary ContactMerna Hamdy Abdelhamid, BSc
Merna-hamdy@dentistry.cu.edu.eg+201060696920
Backup ContactMohamed Atef abdelrasoul, PhD
Mohammedatef@dentistry.cu.edu.eg+201009612708

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026