Sandwich OsteotomyNCT04006678
Evaluation of Accuracy of Computer Guided Versus Conventional Segmental Sandwich Osteotomy With Immediate Implant Placement in Vertically Deficient Anterior Maxilla
A study testing computer guided sandwich osteotomy in people with Sandwich Osteotomy, run by Cairo University.
Trial summary
In conventional segmental sandwich osteotomy technique the moving the transport segment inferiorly to increase the vertical height causes the segment to move bucco-palatally, increasing the horizontal defect. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sandwich Osteotomy
- What is being tested?
- computer guided sandwich osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Aug 2020
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with vertically deficient anterior maxillary ridge a minimum 10 mm. height of alveolar bone.
- Patients with medical history that did not hinder implant placement (uncontrolled diabetes) and adequate proper oral hygiene.
- Patients of adequate alveolar bone width.
- Both genders males and females will be included.
Who cannot join
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
- Pregnant or nursing.
Show all 18Show fewer
- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
- Active infection or severe inflammation in the area intended for implant placement.
- Need of bone augmentation procedures at implant placement.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- Patients participating in other studies, if the present protocol could not be properly followed.
- Referred only for implant placement or unable to attend a 5-year follow-up.
- Requiring only single implant-supported crowns.
Trial locations and contacts
No sites are listed yet.
About this study
In conventional segmental sandwich osteotomy technique the moving the transport segment inferiorly to increase the vertical height causes the segment to move bucco-palatally, increasing the horizontal defect. So using the computer guided in segmental sandwich osteotomy and fixation the transport segment hopefully will reduce the bucco-palatal tipping.
- Conditions
- Sandwich Osteotomy
- Being tested
- computer guided sandwich osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer guided sandwich osteotomyProcedure or surgery
segmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla. Either using surgical guides (Computer guide segmental sandwich osteotomy technique) for study group and conventional segmental sandwich osteotomy technique for control group.
| Study group | Role | What they receive |
|---|---|---|
| computer guided sandwich osteotomy | Experimental | segmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla. Either using surgical guides (Computer guide segmental sandwich osteotomy technique) for study group and conventional segmental sandwich osteotomy technique for control group. Receives: Procedure: computer guided sandwich osteotomy |
| conventional sandwich osteotomy | Active comparator | :conventional segmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla. Receives: Procedure: computer guided sandwich osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
bucco - palatal tipping
calculate the amount of bucco-palaltal tipping of mobilized transport segment after 6 months in mm by cone beam CT between both groups.
Measured: 6 months
Secondary outcomes (1)
marginal bone loss
calculate marginal bone loss in mm by cone beam CT between two groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startJul 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sandwich OsteotomyStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shareif Qassim Shareif Nazzal, Cairo University
- Investigators
- shareif nazzal, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006678
- Sponsor's protocol ID
- CEBD-CU-18-06-2019
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy of Computer Guided Versus Conventional Segmental Sandwich Osteotomy With Immediate Implant Placement in Vertically Deficient Anterior Maxilla
- ClinicalTrials.gov ID
- NCT04006678
- Acronym / sponsor ID
- CEBD-CU-18-06-2019
- Conditions
- Sandwich Osteotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 5 Jul 2019 (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.
In conventional segmental sandwich osteotomy technique the moving the transport segment inferiorly to increase the vertical height causes the segment to move bucco-palatally, increasing the horizontal defect. So using the computer guided in segmental sandwich osteotomy and fixation the transport segment hopefully will reduce the bucco-palatal tipping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer guided sandwich osteotomy | Experimental | Procedure: computer guided sandwich osteotomysegmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla. Either using surgical guides (Computer guide segmental sandwich osteotomy technique) for study group and conventional segmental sandwich osteotomy technique for control group. |
| conventional sandwich osteotomy | Active comparator | Procedure: computer guided sandwich osteotomy:conventional segmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with vertically deficient anterior maxillary ridge a minimum 10 mm. height of alveolar bone.
- Patients with medical history that did not hinder implant placement (uncontrolled diabetes) and adequate proper oral hygiene.
- Patients of adequate alveolar bone width.
- Both genders males and females will be included.
Key exclusion criteria (18 listed)
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
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 |
|---|---|---|
| computer guided sandwich osteotomysegmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla. Either using surgical guides (Computer guide segmental sandwich osteotomy technique) for study group and conventional segmental sandwich osteotomy technique for control group. | Procedure or surgery | computer guided sandwich osteotomy, conventional sandwich osteotomy |
Primary outcome
bucco - palatal tipping
Time frame: 6 months
calculate the amount of bucco-palaltal tipping of mobilized transport segment after 6 months in mm by cone beam CT between both groups.
1 secondary outcome
marginal bone loss
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Sandwich Osteotomy
Active, not recruitingPhase 1
Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique
Alveolar Bone Resorption
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.
shareif nazzal principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing computer guided sandwich osteotomy in people with Sandwich Osteotomy, run by Cairo University.
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 4 inclusion and 18 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Shareif Ali, PhD (+201001932020, surgeryeb@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bucco - palatal tipping (time frame: 6 months). 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 5 Jul 2019.