NCT07816107

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Jan 2025Dec 2026

Study Start

First participant enrolled

January 24, 2025

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

1.9 years

First QC Date

September 7, 2026

Last Update Submit

September 7, 2026

Conditions

Vertical Bone DefectsMissing Tooth/Teeth

Keywords

Sinus liftingDental implantsBone graftingCustomized surgical guide

Outcome Measures

Primary Outcomes (1)

  • Bone density

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

    3 months and 6 months postoperative

Secondary Outcomes (3)

  • Vertical bone height gained

    3 months and 6 months postoperative

  • Bone volume

    3 months and 6 months postoperative

  • Implant stability

    Immediately following implant placement and after 6 months postoperatively

Study Arms (2)

Group A

ACTIVE COMPARATOR

Traditional sequence following standard protocols (sinus elevation, implant, bone graft) using a customized surgical guide.

Procedure: Traditional sequence

Group B

EXPERIMENTAL

Modified sequence (sinus elevation, bone graft, and subsequent implant placement) using a customized surgical guide.

Procedure: Modified sequence

Interventions

Traditional sequencePROCEDURE

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

Group A
Modified sequencePROCEDURE

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

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ahmed Atito Said Sayed, B. D. S

CONTACT

+201026794490ahmed.atito@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Degree Candidate

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 11, 2026

Study Start

January 24, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)