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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Maxillary Sinus Floor Augmentation
• Intervention / Treatment: Device: densah drill technique

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

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 3111
    • Faculty of Dentistry, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Densah drill technique for maxillary sinus floor elevation; 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	Device: densah drill technique; ten patients with maxillary sinus pneumatization will be undergo sinus floor elevation using densah drill technique with implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CBCT for all patients	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	immediate and after 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of pain evaluated clinically for all patients	using visual analogue scale:0 represent no pain and 10 represents the highest level of pain	one week
soft tissue healing evaluated clinically for all patients	presence of dehiscence and exposure of bone or not	one week
infection evaluated clinically for all patients	presence of signs of infection or not	one week
Evaluation of surgical site for edema	will 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 ..	one week

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Asmaa El Mostafa, faculty of dentistry Tanta university

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Estimated): April 25, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: maxillary sinus floor elevation; implant placement; Densah drill
• Other Study ID Numbers: Tanta U 1712

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No