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Evaluation of Crestal Sinus Floor Elevation Using Densah Burs Via Surgical Guide and Simultaneous Implant Placement

Evaluation of Crestal Sinus Floor Elevation Using Densah Burs Via Surgical Guide and Simultaneous Implant Placement

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06902454
Enrollment
10
Registered
2025-03-30
Start date
2024-06-20
Completion date
2026-06-20
Last updated
2026-01-21

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

Conditions

Maxillary Sinus Floor Augmentation

Keywords

maxillary sinus floor elevation, implant placement, Densah drill

Brief summary

Ten patients with missing maxillary posterior teeth and maxillary sinus pneumatization in this study .the floor of maxillary sinus will be elevated using densah drill via surgical guide with simultaneous implant placement . patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

Detailed description

purpose: This study aimed to evaluate maxillary sinus lifting using Densah burs assisted via surgical guide for simultaneous implant installation in atrophic posterior maxilla. Materials and Methods: Ten patients with missing maxillary posterior teeth and maxillary sinus pneumatization in this study .the floor of maxillary sinus will be elevated using densah drill via surgical guide with simultaneous implant placement The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University. Preoperative evaluation: all patients will be examined clinically and radiographically using Panoramic view to assess the condition of upper and lower jaws mainly bony tissues and Cone beam CT(CBCT) scan to identify the quality and quantity (width, length) of the bone at the surgical site, design and fabricate surgical guide. Surgical procedure:, a crestal incision will be made and a full thickness mucoperiosteal flap will be elevated, surgical guide will be prepared and adapted to ridge, supported to the neighboring teeth. and the densah drill will be used as the same manner by manufacture ,bone graft will be inserted at the osteotomy site and the implant will be inserted at this site and using osstell ISQ scale to measure implant primary stability. Flap will be sutured using 3-0 vicryl sutures. Postoperative evaluation: All patients will be followed up at the first week, one month and 4 months postoperatively both clinically if there is pain ,edema , inflamation and radiographically CBCT immediate and 4 months to Detect the amount of elevation will be measured by drawing a tangential line against the implant surface, just above the sinus floor, a measurement will be taken up to the point where the graft material will be seen covering the top of the implant apex ,Detect density of bone graft

Interventions

DEVICEdensah drill technique

ten patients with maxillary sinus pneumatization will be undergo sinus floor elevation using densah drill technique with implant placement

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Residual bone ridge below the sinus floor ≥ 4 mm ≤6mm. 2. Patients should have no sinus pathology detected radiographically. 3. Inter arch space≥8mm.

Exclusion criteria

1. patients with any systemic diseases that affect osseointegration rates. 2. Heavy smokers (\>14 cigarettes per day) . 3. pathological lesions in the maxillary sinus.

Design outcomes

Primary

MeasureTime frameDescription
CBCT for all patientsimmediate and after 4 monthsDetect the amount of elevation will be measured by drawing a tangential line against the implant surface, just above the sinus floor, a measurement will be taken up to the point where the graft material will be seen covering the top of the implant apex, Detect density of bone graft

Secondary

MeasureTime frameDescription
degree of pain evaluated clinically for all patientsone weekusing visual analogue scale:0 represent no pain and 10 represents the highest level of pain
soft tissue healing evaluated clinically for all patientsone weekpresence of dehiscence and exposure of bone or not
infection evaluated clinically for all patientsone weekpresence of signs of infection or not
Evaluation of surgical site for edemaone weekwill be performed using a horizontal and vertical guide with a tape on four reference points: tragus, outer corner of the mouth, outer canthus of the eye and angle of the mandible . The horizontal measure corresponds to the distance between the outer corner of the mouth and the tragus. The vertical measure corresponds to the distance between the outer canthus of the eye and the angle of the mandible. The percentage of facial swelling will be obtained from the difference between measurements made in the immediately and postoperative periods, dividing the result by the value obtained in the immediately period ..

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORAsmaa El Mostafa

faculty of dentistry Tanta University

Outcome results

None listed

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