Alveolar Bone LossNCT06313229
Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation
A study testing implant placement 6 months after ridge augmentation and implant placement Simultaneously with ridge augmentation in people with Alveolar Bone Loss and Dental Implant Failed, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The purpose of this study was to report the clinical and radiographical outcomes of using autogenous cortical bone plates combined with sticky allogenic bone graft for augmenting maxillary anterior atrophic combined horizontal and vertical ridge defects with simultaneous versus staged implant placement. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Dental Implant Failed
- What is being tested?
- implant placement 6 months after ridge augmentation and implant placement Simultaneously with ridge augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2024to 18 May 2027
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health at the time of surgery
- At least 3 months of healing after tooth extraction
- Horizontally and vertical compromised alveolar ridges
Who cannot join
- Thick cortex in the labial/buccal with less cancellous bone inside;
- Obvious undercut on the labial/buccal side
- Uncontrolled periodontal conditions or other oral disorders;
- history of radiotherapy in the head and neck region
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 214312
About this study
Official title: Simultaneous Versus Staged Implant Placement With Vertical and Horizontal Bone Augmentation Using Autogenous Cortical Bone Plates Combined With a Mixture of Platelet-rich Fibrin and Allobone Grafts.
The purpose of this study was to report the clinical and radiographical outcomes of using autogenous cortical bone plates combined with sticky allogenic bone graft for augmenting maxillary anterior atrophic combined horizontal and vertical ridge defects with simultaneous versus staged implant placement.
Read the detailed description
Sufficient alveolar ridge is a prerequisite for successful implant stability, atrophic ridges defects make the placement of regular implants challenging. A variety of materials and surgical techniques are available for bone augmentation procedures prior implant placement. The present study evaluated the effect of sticky allogenic bone graft for the horizontal and vertical ridge augmentation with simultaneous implant placement using autogenous cortical bone plates in maxillary anterior atrophic ridge defects.
Forty-two patients, with severe maxillary anterior horizontal and vertical atrophic ridge deficiencies were randomly assigned to two groups: staged approach group and simultaneous implant placement group. The two groups were grafted using bone plated buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft. Radiographic examination was performed immediately before bone grafting procedure and at 6, 12 months postoperatively, to evaluate the change of bone width and height.
- Conditions
- Alveolar Bone Loss, Dental Implant Failed
- Being tested
- implant placement 6 months after ridge augmentation, implant placement Simultaneously with ridge augmentation
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placement 6 months after ridge augmentationProcedure or surgery
the deficient ridge was grafted first followed by implant placement after 6-monthes
implant placement Simultaneously with ridge augmentationProcedure or surgery
the deficient ridge was grafted and followed by implant placement simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Staged implant placement approach | Experimental | the bone defect was grafted using bone plates buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft. 6 months later the implant was placed in the grafted site. Receives: Procedure: implant placement 6 months after ridge augmentation |
| Simultaneous implant placement approach | Experimental | the bone defect was grafted using bone plates buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft combined with simultaneous implant placement. Receives: Procedure: implant placement Simultaneously with ridge augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability Quotient of Implants (SQI)
The implant stability was recorded using Osstell TM. Following implant insertion, SQI readings were taken immediately, then again after six and twelve months.
Measured: 36-month.
Horizontal bone dimensions (HBDs)
The HBD alterations were assessed by measuring horizontal spacing between the external edges of labial and palatal bony plates at a level 2mm apical of the fixture platform.
Measured: 36-month.
Peri-implant Bone Density (PBD)
For consistent measurement of the PBD, 1-mm-diameter Region of interest (RI) was selected and traced 1.2 mm distant from the fixture on the cross-sectional slices followed by counting the threshold pixels inside the RI.
Measured: 36-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Apr 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion18 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- 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
- Model description
- single-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
- Investigators
- Walid AH Elamrousy, PhD, Principal investigator, Faculty of Oral and Dental Medicine, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313229
- Sponsor's protocol ID
- KFSIRB200-195
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Versus Staged Implant Placement With Vertical and Horizontal Bone Augmentation Using Autogenous Cortical Bone Plates Combined With a Mixture of Platelet-rich Fibrin and Allobone Grafts.
- ClinicalTrials.gov ID
- NCT06313229
- Acronym / sponsor ID
- KFSIRB200-195
- Conditions
- Alveolar Bone Loss, Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 18 May 2027 (estimated)
- First posted
- 15 Mar 2024 (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 purpose of this study was to report the clinical and radiographical outcomes of using autogenous cortical bone plates combined with sticky allogenic bone graft for augmenting maxillary anterior atrophic combined horizontal and vertical ridge defects with simultaneous versus staged implant placement.
Detailed description
Sufficient alveolar ridge is a prerequisite for successful implant stability, atrophic ridges defects make the placement of regular implants challenging. A variety of materials and surgical techniques are available for bone augmentation procedures prior implant placement. The present study evaluated the effect of sticky allogenic bone graft for the horizontal and vertical ridge augmentation with simultaneous implant placement using autogenous cortical bone plates in maxillary anterior atrophic ridge defects.
Forty-two patients, with severe maxillary anterior horizontal and vertical atrophic ridge deficiencies were randomly assigned to two groups: staged approach group and simultaneous implant placement group. The two groups were grafted using bone plated buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft. Radiographic examination was performed immediately before bone grafting procedure and at 6, 12 months postoperatively, to evaluate the change of bone width and height.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- single-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Staged implant placement approach | Experimental | Procedure: implant placement 6 months after ridge augmentationthe bone defect was grafted using bone plates buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft. 6 months later the implant was placed in the grafted site. |
| Simultaneous implant placement approach | Experimental | Procedure: implant placement Simultaneously with ridge augmentationthe bone defect was grafted using bone plates buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft combined with simultaneous implant placement. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general health at the time of surgery
- At least 3 months of healing after tooth extraction
- Horizontally and vertical compromised alveolar ridges
Key exclusion criteria (4 listed)
- Thick cortex in the labial/buccal with less cancellous bone inside;
- Obvious undercut on the labial/buccal side
- Uncontrolled periodontal conditions or other oral disorders;
- history of radiotherapy in the head and neck region
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 |
|---|---|---|
| implant placement 6 months after ridge augmentationthe deficient ridge was grafted first followed by implant placement after 6-monthes | Procedure or surgery | Staged implant placement approach |
| implant placement Simultaneously with ridge augmentationthe deficient ridge was grafted and followed by implant placement simultaneously | Procedure or surgery | Simultaneous implant placement approach |
Primary outcome
Stability Quotient of Implants (SQI)
Time frame: 36-month.
The implant stability was recorded using Osstell TM. Following implant insertion, SQI readings were taken immediately, then again after six and twelve months.
Horizontal bone dimensions (HBDs)
Time frame: 36-month.
The HBD alterations were assessed by measuring horizontal spacing between the external edges of labial and palatal bony plates at a level 2mm apical of the fixture platform.
Peri-implant Bone Density (PBD)
Time frame: 36-month.
For consistent measurement of the PBD, 1-mm-diameter Region of interest (RI) was selected and traced 1.2 mm distant from the fixture on the cross-sectional slices followed by counting the threshold pixels inside the RI.
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 25 Aug 2026.
- Individual participant dataSharing planned: Undecided. undecided
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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. This study is not recruiting at the moment.
Walid AH Elamrousy, PhD principal investigator
Faculty of Oral and Dental Medicine, Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant placement 6 months after ridge augmentation and implant placement Simultaneously with ridge augmentation in people with Alveolar Bone Loss and Dental Implant Failed, run by Kafrelsheikh 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability Quotient of Implants (SQI) (time frame: 36-month.). The study lists 3 primary outcomes in all. 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 25 Aug 2026.