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Clinical Trials/NCT06681857
NCT06681857
Completed
Not Applicable

Evaluation of Simultaneous Implant Placement and Maxillary Sinus Floor Elevation With Gelatin Sponge Versus Allogenic Demineralized Bone Matrix: (A Randomized Controlled Clinical Trial)

Beni-Suef University1 site in 1 country14 target enrollmentDecember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maxillary Sinus Disease
Sponsor
Beni-Suef University
Enrollment
14
Locations
1
Primary Endpoint
Vertical bone gain
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

The post-extraction pneumatization of the maxillary sinus often compromises the ability of the maxillary molar to the optimal recipient of dental implants as a consequence of the quantitative reduction of the vertical bone height and the reduced bone quality of the region posterior maxillary segment.

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
September 9, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Nagi Alghandour

Lecturer

Beni-Suef University

Eligibility Criteria

Inclusion Criteria

  • Patients of both sexes, with an age range of (25 to 55 years) with unilateral or bilateral edentulous posterior maxillary molar region with \\ vertical residual bone height of (four to six millimeters), a minimal horizontal bone width of six millimeters bone width, acceptable interarch space, and fair inter-jaw anteroposterior, horizontal and vertical relationships.
  • Proper general health and oral hygiene.

Exclusion Criteria

  • The presence of sinusitis, local sinus pathosis, or a systemic disease that would affect the final treatment outcomes, bone remodeling process, or maxillary sinus health.
  • Those patients with a history of previous bone graft, sinus lift, or failed implant.

Outcomes

Primary Outcomes

Vertical bone gain

Time Frame: 6 months

baseline and final outcome for measuring both groups' radiographic vertical bone height gain as a primary outcome aided by the (Blue-sky software) identification of four reference points along each implant buccal, palatal, mesial, and distal surface

Stability

Time Frame: 6 months

Aided by the Osstell device, the authors will record the (ISQ) readings at implant placement and upon its exposure for prosthetic rehabilitation after six months as a secondary outcome. The mean (ISQ) of the maxillary sinus lift procedure would employ the mean of parallel and perpendicular (ISQ) readings to each implant long axis where one implant is inserted and the mean of the two implant readings when two implants are placed. The numerical data concerning the primary and secondary outcomes will be recorded, scheduled, and submitted for statistical analysis

Study Sites (1)

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