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CompletedNCT06681857Updated Sep 10, 2025

Maxillary Sinus Floor Elevation With Gelatin Sponge Versus Allogenic Demineralized Bone Matrix

An interventional study of Sinus lifting in Maxillary Sinus Disease, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
25 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Maxillary Sinus Disease
03

In context

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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.
  2. Proper general health and oral hygiene.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Those patients with a history of previous bone graft, sinus lift, or failed implant.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Active comparator
    Test group: Gelatin Sponge

    The surgical intervention will be executed under local anesthesia. After the elevation of the full-thickness mucoperiosteal flap over the lateral wall of the maxillary sinus, a circular lateral window will be created by sinus low-speed bur grinding of the cortical ring to guard against the Shniederian membrane violation, followed by its separation along the sinus floor, lateral walls and the boundaries of the window to elaborate a smooth superior membrane elevation. The created spaces beneath the elevated Shniederian membrane will be filled up by an absorbable gelatin sponge for the test group patients followed by the coverage of the side window with collagen membrane, secured with bone tacks to guard against the graft fibroblastic invasion.

    Procedure: Sinus lifting

  • Active comparator
    Control group: Allogenic Demineralized Bone Matrix

    The surgical intervention will be executed under local anesthesia. After the elevation of the full-thickness mucoperiosteal flap over the lateral wall of the maxillary sinus, a circular lateral window will be created by sinus low-speed bur grinding of the cortical ring to guard against the Shniederian membrane violation, followed by its separation along the sinus floor, lateral walls and the boundaries of the window to elaborate a smooth superior membrane elevation. The created spaces beneath the elevated Shniederian membrane will be filled up by allogenic (DBM) for the control group patients, followed by the coverage of the side window with collagen membrane, secured with bone tacks to guard against the graft fibroblastic invasion.

    Procedure: Sinus lifting

Interventions

  • ProcedureSinus lifting

    The implant osteotomy will be initiated by pilot drill entries followed by sequential drills via the radiographic stent's sleeves to position the fixtures precisely into the pre-determined recipient sites. The Implant stability quotient (ISQ) will then be measured using an Osstell device after attaching intelligent implant pigs. Finally, the mucoperiosteal flaps will be sutured in place with 4-0 Prolene.

06

What researchers measure

Primary outcomes

  1. Vertical bone gain

    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

    Time frame: 6 months

  2. Stability

    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

    Time frame: 6 months

07

Study locations

1 site
  • Beni-suef university
    Banī Suwayf, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06681857
Lead sponsor
Beni-Suef University
Responsible party
Ahmed Nagi Alghandour (Lecturer, Beni-Suef University) — Principal investigator
First posted
Nov 8, 2024
Start date
Dec 1, 2024
Primary completion
Sep 1, 2025
Completion
Sep 9, 2025
Last update
Sep 10, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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