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Enrolling by invitation NCT06902454

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

No phase Interventional Maxillary Sinus Floor Augmentation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: densah drill technique.
Who it may be relevant to
Registry conditions: Maxillary Sinus Floor Augmentation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • CBCT for all patients [Time frame: immediate and after 4 months]
Secondary outcome measures (4)
  • degree of pain evaluated clinically for all patients [Time frame: one week]
  • soft tissue healing evaluated clinically for all patients [Time frame: one week]
  • infection evaluated clinically for all patients [Time frame: one week]
  • Evaluation of surgical site for edema [Time frame: one week]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Tanta University — Tanta

Identifiers

NCT: NCT06902454 · Tanta U 1712

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗