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NCT Number: NCT07816107

Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide

The aim of this randomized clinical trial is to evaluate the effect of changing the sequence of bone grafting during maxillary sinus lifting and simultaneous dental implant placement. The study compares a traditional sequence (sinus elevation, implant placement, then bone grafting) with a modified sequence (sinus elevation, bone grafting, then implant placement). Both procedures utilize a customized surgical guide and are performed on patients with a vertical bone measurement of 5 mm or slightly more. The primary goal is to assess bone density, along with secondary outcomes including vertical bone height gained, bone volume, and implant stability.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location status: Recruiting

Location contact

Hesham El-Hawary, Phd

PRINCIPAL_INVESTIGATOR

Hesham El-Hawary, Professor

CONTACT

[email protected]

+201144446373

About this study

Maxillary sinus floor augmentation (MSFA) is a common procedure to restore vertical bone defects in the posterior maxilla to allow for oral rehabilitation using dental implants. However, traditional techniques can have demerits such as increased operative time, liability to infection, and increased complication rates. Despite advancements made to improve the surgical technique, several complications can yet arise which may compromise the success of the operation.

This study aims to enhance surgical sequences and compare the efficacy of sinus elevation, implant, and bone graft procedures using a customized surgical guide. The guide includes a lateral window for sinus elevation and a drill guiding hole for implant replacement. The study hypothesizes that the modified sequence (sinus elevation, bone graft, implant) is more accurate and provides better outcomes regarding bone density, stability, and height of the gained bone compared to the traditional sequence (sinus elevation, implant, bone graft).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age more than 18 years.
  • Both sexes.
  • Patients eligible for maxillary sinus elevation, implant, and bone graft procedures.
  • Adequate general health for dental interventions.
  • Vertical bone measurement of 5 mm or slightly more.

Exclusion criteria

  • Systemic conditions affecting implant success.
  • Patients with vertical bone measurement less than 5 mm.
  • Previous sinus surgery or dental implant failure.
  • Medication that can impair or interfere with normal bone metabolism.
  • History of head and neck radiotherapy.
  • Pregnancy.

Treatment and study plan

Traditional sequence

Procedure

Sinus elevation is performed, followed by implant placement, and finally packing the opened lateral window with bone graft, all using a customized surgical guide.

Modified sequence

Procedure

Sinus elevation is performed, followed by packing the sinus with bone graft, and then implant osteotomies are drilled, all using a customized surgical guide.

Primary outcomes

  1. Bone density

    Time frame: 3 months and 6 months postoperative

    Assessed using Cone-beam computed tomography (CBCT) and measured in Hounsfield Units (HU)

Secondary outcomes

  1. Vertical bone height gained

    Time frame: 3 months and 6 months postoperative

    Evaluated using Cone-beam computed tomography (CBCT) and measured in millimeters (mm)

  2. Bone volume

    Time frame: 3 months and 6 months postoperative

    Computed using Cone-beam computed tomography (CBCT) and measured in cubic centimeters (cm3)

  3. Implant stability

    Time frame: Immediately following implant placement and after 6 months postoperatively

    Measured by an implant stability meter (OsstellISQ®) in ISQ VALUE

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Atito Said Sayed, B. D. S

CONTACT

[email protected]

+201026794490

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 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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