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OpenTrials
Completed

NCT Number: NCT06681857

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

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beni-suef university

Banī Suwayf, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Sinus lifting

Procedure

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.

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
Sep 10, 2025

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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