Vertical Ridge DeficiencysandwichNCT06089928
Fixation Free Sandwich Osteotomy With an Interpositional Inlay Graft in Compere to Conventional Sandwich Osteotomy
A study testing vertical augmentation in people with Vertical Ridge Deficiency and Atrophic Maxilla, run by Cairo University at 1 site in Egypt.
Trial summary
The atrophatic anterior maxilla present a considerable challenge for both surgical and prosthetic rehabilitation, as it may require bone augmentation to enable implant placement. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vertical Ridge Deficiency, Atrophic Maxilla
- What is being tested?
- vertical augmentation
- 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
- 1 Jan 2024to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both sex
- Adulte patient (18-60 y.)
- Highly motivated patient with good oral hygiene
- No systematic diseases or conditions known to alter bone healing.
- No local pathosis that may interfere with bone healing.
- No recent history of augmentation procedure at the same area.
Show all 11Show fewer
- Criteria of the edentulous ridge:
- The anterior maxillary vertical dimension is minimum 10mm, measured from the crest of the ridge to the nasal floor.
- Horizontal ridge dimension remains normal; at least 6mm.
- The minimum number of the missing teeth is minimum 2 teeth and the maximum will be the six anteriors.
- There will be increased inter-arch space compared with the adjacent teeth.
Who cannot join
- uncontrolled Diabetes mellitus (DM)
- pregnancy
- uncontrolled local factors(periodontitis), or acute infection related to the aera.
- smoking: more than 20 cigarettes \day
- intravenous bisphosphonate
- patients who had received radiation treatment in the head and neck region.
- previous bone augmentation in the site within 6 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo university
Cairo, 3753450
Heba A. Ammar, MSc, 00201551574205 ext. 00201147497876, heba.ammar@dentistry.cu.edu.eg
Tarek A. El-ghareeb, PhD, 00201227418235 ext. 00201282931864, T.elghareeb@dentistry.cu.edu.eg
About this study
Official title: Fixation Free Sandwich Osteotomy for Vertical Ridge Augmentation in Aesthetic Zone Versus Conventional Sandwich Osteotomy: A Randomized Controlled Clinical Trial
The atrophatic anterior maxilla present a considerable challenge for both surgical and prosthetic rehabilitation, as it may require bone augmentation to enable implant placement. The techniques proposed for vertical augmentation of the alveolar ridge include distraction osteogenesis, only grafting, and sandwich osteoplasty. Sandwich osteotomy is reported to provide more stable and predictable results with respect to the height of the alveolar ridge. The main advantage of osteotomy techniques that employ Interpositional bone grafts is reported to be the improved blood supply in the augmented region.
Read the detailed description
the investigators aim to evaluate the radiographical, clinical differences of newly formed bone following vertical maxillary ridge augmentation using sandwich inlay with autogenous bone block from the rums without fixation (study group I) compared to same procedure with fixation (micro plates and screw) (control group).
description of intervention:
- diagnostic procedure:
- All Participant will be selected according to inclusion and exclusion criteria.
- Comprehensive clinical examination and understanding of patient's chief complaints will be carried out.
- All participants will be informed about the surgical treatment procedure and will provide their written consent to participate in the study.
- Preoperative panoramic radiograph will be requested prior as general screening for any pathosis and primary maxillary anterior residual bone height assessment.
- A (CBCT) scan will be requested for each patient to confirm amount of horizontal and vertical bone, to exactly measure the amount of bone height and to plan and guide surgical procedures of block graft.
- Alginate Impressions of upper \& lower jaws will be taken for acquiring diagnostic dental casts. intra-surgical procedure :
Harvesting procedures of the mandibular ramus block graft:
After administering local anesthesia, a soft tissue incision will be made in the posterior mandible to create an envelope flap similar to that created in a third molar extraction, with an external oblique incision extending anteriorly into the buccal sulcus of the respective molar sites. A mucoperiosteal full-thickness flap will be then reflected with a sharp periosteal elevator, exposing the lateral aspect of the ramus. Osteotomies to take ABB will be performed in the ramus using trephine drills. The size of the block depended on the size of the graft needed. The size of the graft will be adjected with diamond discs under saline irrigation. Donor sites will be closed after the bone graft procedure will be completed. Recipient site preparation:
Following the administration of local anesthesia, a soft tissue incision will be performed. After a full-thickness mucoperiosteal flap will be reflected, the alveolar bone exposed. The edentulous area and the residual bone ridge will be prepared carefully to receive the bone graft; the defect dimensions will be measured with a periodontal probe to determine the approximate size of the block graft to be harvested or amount of particle bone graft needed.
Three full-thickness bony cuts will be performed. Two vertical stop cuts will be made using a tungsten carbide disc at the distal ends of the mid-crestal bony cut on the facial surface of alveolar ridge; the vertical cuts will be 3 mm from the neighboring teeth. The above-described cuts will be revised using ridge-splitting osteotomes (fine chisels) of sequential width (2 mm, 3 mm) and a lightweight mallet. The rectangular bony segment (transport segment) will be mobilized occlusally and be pedicled on the palatal mucoperiosteum. The autogenous blocks will be fitted between the mobilized segment and the basal bone, and the remining gap will be filled with particulated autogenous bone, in test group; there is no mean of fixation will be used while in the control group the segment will be fixed using micro-plates and screws. Scoring will be done to allow tension-free closure.
- Conditions
- Vertical Ridge Deficiency, Atrophic Maxilla
- Being tested
- vertical augmentation
- Keywords
- sandwich osteotomy, vertical augmentation,, aesthetic zone, Interpositional graft, fixation free
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vertical augmentationProcedure or surgery
Also called segmental osteotomy with Interpositional graft
sandwich osteotomy with an Interpositional inlay graft
| Study group | Role | What they receive |
|---|---|---|
| fixation free | Active comparator | sandwich osteotomy with Interpositional graft without fixation. Receives: Procedure: vertical augmentation |
| conventional sandwich osteotomy | Active comparator | sandwich osteotomy with Interpositional graft with fixation. Receives: Procedure: vertical augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographical bone gain
amount of vertical bone gain in millimeter using cone beam CT scan
Measured: 4-months
radiographical bone change
amount of bone change in millimeter using cone beam CT scan
Measured: 4- months
Secondary outcomes (4)
clinical pain
pain measure on a scale using visual analog scale
Measured: 1-3days
clinical edema
measure by edema index in terms of grades with minimum 1(better outcome and maximum 4( worse outcome)
Measured: 1-7 days
clinical infection
binary as present or not present
Measured: 1-5 days
clinical dehiscence
binary as present or not present
Measured: 1-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertical Ridge DeficiencyStudies 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
- Model description
- clinical and radiographical comparisons of newly formed bone following vertical ridge augmentation which is achieved by use sandwich osteotomy with Interpositional inlay graft (ramus block) without fixation (test group), and same procedure with using micro-plates and screws as a mean of fixation (control group).
- 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, Heba Ashour Ammar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089928
- Sponsor's protocol ID
- segmental osteotomy
- Acronym
- sandwich
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected individual participant data including diagnosis, treatment plane, surgical intervention, outcome assessment, results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation Free Sandwich Osteotomy for Vertical Ridge Augmentation in Aesthetic Zone Versus Conventional Sandwich Osteotomy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06089928
- Acronym / sponsor ID
- sandwich / segmental osteotomy
- Conditions
- Vertical Ridge Deficiency, Atrophic Maxilla
- Keywords
- sandwich osteotomy, vertical augmentation,, aesthetic zone, Interpositional graft, fixation free
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 19 Oct 2023 (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 atrophatic anterior maxilla present a considerable challenge for both surgical and prosthetic rehabilitation, as it may require bone augmentation to enable implant placement. The techniques proposed for vertical augmentation of the alveolar ridge include distraction osteogenesis, only grafting, and sandwich osteoplasty. Sandwich osteotomy is reported to provide more stable and predictable results with respect to the height of the alveolar ridge. The main advantage of osteotomy techniques that employ Interpositional bone grafts is reported to be the improved blood supply in the augmented region.
Detailed description
the investigators aim to evaluate the radiographical, clinical differences of newly formed bone following vertical maxillary ridge augmentation using sandwich inlay with autogenous bone block from the rums without fixation (study group I) compared to same procedure with fixation (micro plates and screw) (control group).
description of intervention:
- diagnostic procedure:
- All Participant will be selected according to inclusion and exclusion criteria.
- Comprehensive clinical examination and understanding of patient's chief complaints will be carried out.
- All participants will be informed about the surgical treatment procedure and will provide their written consent to participate in the study.
- Preoperative panoramic radiograph will be requested prior as general screening for any pathosis and primary maxillary anterior residual bone height assessment.
- A (CBCT) scan will be requested for each patient to confirm amount of horizontal and vertical bone, to exactly measure the amount of bone height and to plan and guide surgical procedures of block graft.
- Alginate Impressions of upper \& lower jaws will be taken for acquiring diagnostic dental casts. intra-surgical procedure :
Harvesting procedures of the mandibular ramus block graft:
After administering local anesthesia, a soft tissue incision will be made in the posterior mandible to create an envelope flap similar to that created in a third molar extraction, with an external oblique incision extending anteriorly into the buccal sulcus of the respective molar sites. A mucoperiosteal full-thickness flap will be then reflected with a sharp periosteal elevator, exposing the lateral aspect of the ramus. Osteotomies to take ABB will be performed in the ramus using trephine drills. The size of the block depended on the size of the graft needed. The size of the graft will be adjected with diamond discs under saline irrigation. Donor sites will be closed after the bone graft procedure will be completed. Recipient site preparation:
Following the administration of local anesthesia, a soft tissue incision will be performed. After a full-thickness mucoperiosteal flap will be reflected, the alveolar bone exposed. The edentulous area and the residual bone ridge will be prepared carefully to receive the bone graft; the defect dimensions will be measured with a periodontal probe to determine the approximate size of the block graft to be harvested or amount of particle bone graft needed.
Three full-thickness bony cuts will be performed. Two vertical stop cuts will be made using a tungsten carbide disc at the distal ends of the mid-crestal bony cut on the facial surface of alveolar ridge; the vertical cuts will be 3 mm from the neighboring teeth. The above-described cuts will be revised using ridge-splitting osteotomes (fine chisels) of sequential width (2 mm, 3 mm) and a lightweight mallet. The rectangular bony segment (transport segment) will be mobilized occlusally and be pedicled on the palatal mucoperiosteum. The autogenous blocks will be fitted between the mobilized segment and the basal bone, and the remining gap will be filled with particulated autogenous bone, in test group; there is no mean of fixation will be used while in the control group the segment will be fixed using micro-plates and screws. Scoring will be done to allow tension-free closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- clinical and radiographical comparisons of newly formed bone following vertical ridge augmentation which is achieved by use sandwich osteotomy with Interpositional inlay graft (ramus block) without fixation (test group), and same procedure with using micro-plates and screws as a mean of fixation (control group).
| Arm | Type | Receives |
|---|---|---|
| fixation free | Active comparator | Procedure: vertical augmentationsandwich osteotomy with Interpositional graft without fixation. |
| conventional sandwich osteotomy | Active comparator | Procedure: vertical augmentationsandwich osteotomy with Interpositional graft with fixation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Both sex
- Adulte patient (18-60 y.)
- Highly motivated patient with good oral hygiene
- No systematic diseases or conditions known to alter bone healing.
- No local pathosis that may interfere with bone healing.
Key exclusion criteria (7 listed)
- uncontrolled Diabetes mellitus (DM)
- pregnancy
- uncontrolled local factors(periodontitis), or acute infection related to the aera.
- smoking: more than 20 cigarettes \day
- intravenous bisphosphonate
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 |
|---|---|---|
| vertical augmentationAlso: segmental osteotomy with Interpositional graftsandwich osteotomy with an Interpositional inlay graft | Procedure or surgery | conventional sandwich osteotomy, fixation free |
Primary outcome
radiographical bone gain
Time frame: 4-months
amount of vertical bone gain in millimeter using cone beam CT scan
radiographical bone change
Time frame: 4- months
amount of bone change in millimeter using cone beam CT scan
4 secondary outcomes
clinical pain
Time frame: 1-3days
clinical edema
Time frame: 1-7 days
clinical infection
Time frame: 1-5 days
clinical dehiscence
Time frame: 1-30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Yes. all collected individual participant data including diagnosis, treatment plane, surgical intervention, outcome assessment, results will be shared
Related trials for Vertical Ridge Deficiency
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RecruitingObservational study
Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.
Alveolar Bone Atrophy, Alveolar Bone Grafting
Not yet recruiting
Radiographic and Histomorphometric Assessment for Alveolar Ridge Preservation Using Autogenous Tooth Graft From Extracted Tooth Combined With Simvastatin 1:1 Versus Autogenous Tooth Graft
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vertical augmentation in people with Vertical Ridge Deficiency and Atrophic Maxilla, 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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographical bone gain (time frame: 4-months). The study lists 2 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 23 Oct 2023.