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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age more than 18 years.

Both sexes.

Patients eligible for maxillary sinus elevation, implant, and bone graft procedures.

Adequate general health for dental interventions.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Traditional sequence

    Procedure/Surgery

    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/Surgery

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

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Bone density

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

Time frame
3 months and 6 months postoperative

Secondary outcomes

1

Vertical bone height gained

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

Time frame
3 months and 6 months postoperative
2

Bone volume

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

Time frame
3 months and 6 months postoperative
3

Implant stability

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

Time frame
Immediately following implant placement and after 6 months postoperatively

Other outcomes

Sponsors and contacts

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