Vertical Bone DefectsNCT07816107
Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide
A study testing Traditional sequence and Modified sequence in people with Vertical Bone Defects and Missing Tooth/Teeth, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertical Bone Defects, Missing Tooth/Teeth
- What is being tested?
- Traditional sequence and Modified sequence
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
Hesham El-Hawary, Professor, +201144446373, hesham.elhawary@dentistry.cu.edu.eg
Hesham El-Hawary, Phd
About this study
Official title: Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide: A Randomized Clinical 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.
Read the detailed description
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).
- Conditions
- Vertical Bone Defects, Missing Tooth/Teeth
- Being tested
- Traditional sequence, Modified sequence
- Keywords
- Sinus lifting, Dental implants, Bone grafting, Customized surgical guide
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional sequenceProcedure or surgery
The surgical procedure involves the following standardized steps:
Creation and elevation of a full-thickness mucoperiosteal flap.
Seating of the customized surgical guide.
Tracing the lateral window outline using a sterile surgical pencil.
Removal of the surgical guide.
Lateral window osteotomy and elevation of the Schneiderian membrane.
Securing and protecting the elevated membrane using a blunt surgical instrument.
Repositioning of the surgical guide.
Preparation of the pilot osteotomy through the guide sleeve.
Removal of the surgical guide and completion of the implant osteotomy sequence via a freehand approach.
Implant insertion and cover screw placement.
Packing of the particulate bone graft into the elevated subantral space.
Placement of a resorbable biological membrane over the lateral window.
Flap repositioning and suturing for primary closure.
Modified sequenceProcedure or surgery
The surgical procedure involves the following standardized steps:
Creation and elevation of a full-thickness mucoperiosteal flap.
Seating of the customized surgical guide.
Tracing the lateral window outline using a sterile surgical pencil.
Removal of the surgical guide.
Lateral window osteotomy and elevation of the Schneiderian membrane.
Securing and protecting the elevated membrane using a blunt surgical instrument.
Repositioning of the surgical guide.
Preparation of the pilot osteotomy through the guide sleeve.
Removal of the surgical guide and completion of the implant osteotomy sequence via a freehand approach.
Packing of the particulate bone graft into the elevated subantral space.
Implant insertion and cover screw placement through the grafted site.
Placement of a resorbable biological membrane over the lateral window.
Flap repositioning and suturing for primary closure.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Traditional sequence following standard protocols (sinus elevation, implant, bone graft) using a customized surgical guide. Receives: Procedure: Traditional sequence |
| Group B | Experimental | Modified sequence (sinus elevation, bone graft, and subsequent implant placement) using a customized surgical guide. Receives: Procedure: Modified sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Assessed using Cone-beam computed tomography (CBCT) and measured in Hounsfield Units (HU)
Measured: 3 months and 6 months postoperative
Secondary outcomes (3)
Vertical bone height gained
Evaluated using Cone-beam computed tomography (CBCT) and measured in millimeters (mm)
Measured: 3 months and 6 months postoperative
Bone volume
Computed using Cone-beam computed tomography (CBCT) and measured in cubic centimeters (cm3)
Measured: 3 months and 6 months postoperative
Implant stability
Measured by an implant stability meter (OsstellISQ®) in ISQ VALUE
Measured: Immediately following implant placement and after 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start24 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertical Bone DefectsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed atito said sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816107
- Sponsor's protocol ID
- 24125
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07816107
- Acronym / sponsor ID
- 24125
- Conditions
- Vertical Bone Defects, Missing Tooth/Teeth
- Keywords
- Sinus lifting, Dental implants, Bone grafting, Customized surgical guide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Traditional sequenceTraditional sequence following standard protocols (sinus elevation, implant, bone graft) using a customized surgical guide. |
| Group B | Experimental | Procedure: Modified sequenceModified sequence (sinus elevation, bone graft, and subsequent implant placement) using a customized surgical guide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional sequenceThe surgical procedure involves the following standardized steps: Creation and elevation of a full-thickness mucoperiosteal flap. Seating of the customized surgical guide. Tracing the lateral window outline using a sterile surgical pencil. Removal of the surgical guide. Lateral window osteotomy and elevation of the Schneiderian membrane. Securing and protecting the elevated membrane using a blunt surgical instrument. Repositioning of the surgical guide. Preparation of the pilot osteotomy through the guide sleeve. Removal of the surgical guide and completion of the implant osteotomy sequence via a freehand approach. Implant insertion and cover screw placement. Packing of the particulate bone graft into the elevated subantral space. Placement of a resorbable biological membrane over the lateral window. Flap repositioning and suturing for primary closure. | Procedure or surgery | Group A |
| Modified sequenceThe surgical procedure involves the following standardized steps: Creation and elevation of a full-thickness mucoperiosteal flap. Seating of the customized surgical guide. Tracing the lateral window outline using a sterile surgical pencil. Removal of the surgical guide. Lateral window osteotomy and elevation of the Schneiderian membrane. Securing and protecting the elevated membrane using a blunt surgical instrument. Repositioning of the surgical guide. Preparation of the pilot osteotomy through the guide sleeve. Removal of the surgical guide and completion of the implant osteotomy sequence via a freehand approach. Packing of the particulate bone graft into the elevated subantral space. Implant insertion and cover screw placement through the grafted site. Placement of a resorbable biological membrane over the lateral window. Flap repositioning and suturing for primary closure. | Procedure or surgery | Group B |
Primary outcome
Bone density
Time frame: 3 months and 6 months postoperative
Assessed using Cone-beam computed tomography (CBCT) and measured in Hounsfield Units (HU)
3 secondary outcomes
Vertical bone height gained
Time frame: 3 months and 6 months postoperative
Bone volume
Time frame: 3 months and 6 months postoperative
Implant stability
Time frame: Immediately following implant placement and after 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional sequence and Modified sequence in people with Vertical Bone Defects and Missing Tooth/Teeth, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Atito Said Sayed, B. D. S (+201026794490, ahmed.atito@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density (time frame: 3 months and 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.