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Enrolling by Invitation

NCT Number: NCT06902454

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.

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Key information

Conditions

Maxillary Sinus Floor Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

densah drill technique

Device

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

Primary outcomes

  1. CBCT for all patients

    Time frame: immediate and after 4 months

    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

Secondary outcomes

  1. degree of pain evaluated clinically for all patients

    Time frame: one week

    using visual analogue scale:0 represent no pain and 10 represents the highest level of pain

  2. soft tissue healing evaluated clinically for all patients

    Time frame: one week

    presence of dehiscence and exposure of bone or not

  3. infection evaluated clinically for all patients

    Time frame: one week

    presence of signs of infection or not

  4. Evaluation of surgical site for edema

    Time frame: one week

    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 ..

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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