Bone LossNCT05666414
Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy
A study testing sandwich interpositional bone grafting computer guided and conventional interpositional bone grafting in people with Bone Loss, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The aim of this study was to assess the efficiency of the computer-guided interpositional sandwich osteotomy for the vertical bone gain and effects on vital structures (inferior dental nerve bundle) compared to free hand interpositional osteotomies. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- sandwich interpositional bone grafting computer guided and conventional interpositional bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2021to 12 Dec 2022
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Edentulous posterior mandibular ridge with vertical loss of alveolar bone with remaining bone height (4-7 mm) above the mandibular canal
- Good oral hygiene
- Highly motivated patients
- Patients seeking fixed prosthesis at posterior mandibular region.
- Patients willing for a surgical procedures follow-up with an informed consent
- Age range 20-65 years
Who cannot join
- • Smokers
- Individuals with dentulous posterior mandible ridge
- Medically compromised patients
- Patients with local pathosis at the surgical area suggested
- Previously subjected to reconstructive procedures of the posterior mandible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy Technique in the Atrophied Posterior Mandible: a Randomized Clinical Trial
The aim of this study was to assess the efficiency of the computer-guided interpositional sandwich osteotomy for the vertical bone gain and effects on vital structures (inferior dental nerve bundle) compared to free hand interpositional osteotomies.
Read the detailed description
in this research a full digital sandwich osteotomy protocol was conducted to be compared with the conventional protocol. the investigators were seeking to determine the significance of using surgical computer software in sandwich interpositional bone grafting at atrophied posterior mandibles and how efficiently can it affect this technique.
- Conditions
- Bone Loss
- Being tested
- sandwich interpositional bone grafting computer guided, conventional interpositional bone grafting
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sandwich interpositional bone grafting computer guidedProcedure or surgery
performing the 2 vertical and the 1 horizontal osteotomies using a cutting patient specific guide and fixation of the vertically elevated bony segment after gap calculation using patient specific fixation guides
conventional interpositional bone graftingProcedure or surgery
performing the conventional interpositional sandwich osteotomies free-hand and fixation of the mobilized bone segment free-hand
| Study group | Role | What they receive |
|---|---|---|
| computer guided sandwich interpositional bone grafting | Experimental | patient specific cutting guide were fabricated to perform the osteotomies ( and another patient specific guide was then fabricated to start the fixation of the cut bony segment a full digital intervention for sandwich interpositional grafting in patients with vertically atrophied mandible (bilateral split mouth study) Receives: Procedure: sandwich interpositional bone grafting computer guided |
| conventional sandwich osteotomy interpositional bone grafting | Active comparator | conventional interpositional bone grafting was done for patients with vertically atrophied mandibles (bilateral split mouth study) Receives: Procedure: conventional interpositional bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of vertical bone gain
measure the amount of vertical bone gained after performing the interpositional sandwich osteotomy
Measured: 4 months
Secondary outcomes (1)
neurosensory affection
measure the affection of the inferior alveolar nerve bundle after performing the interpositional sandwich osteotomy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start25 Nov 2021
- Primary completion1 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khaled Mohamed, Future University in Egypt
- Investigators
- ahmed k mohamed, BDS, Principal investigator, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666414
- Sponsor's protocol ID
- (24)/11-2021
- Status last verified
- Dec 2022
- First submitted
- 17 Dec 2022
- Last updated
- 3 Jan 2023
- 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 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy Technique in the Atrophied Posterior Mandible: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05666414
- Acronym / sponsor ID
- (24)/11-2021
- Conditions
- Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 27 Dec 2022 (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 study was to assess the efficiency of the computer-guided interpositional sandwich osteotomy for the vertical bone gain and effects on vital structures (inferior dental nerve bundle) compared to free hand interpositional osteotomies.
Detailed description
in this research a full digital sandwich osteotomy protocol was conducted to be compared with the conventional protocol. the investigators were seeking to determine the significance of using surgical computer software in sandwich interpositional bone grafting at atrophied posterior mandibles and how efficiently can it affect this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer guided sandwich interpositional bone grafting | Experimental | Procedure: sandwich interpositional bone grafting computer guidedpatient specific cutting guide were fabricated to perform the osteotomies ( and another patient specific guide was then fabricated to start the fixation of the cut bony segment a full digital intervention for sandwich interpositional grafting in patients with vertically atrophied mandible (bilateral split mouth study) |
| conventional sandwich osteotomy interpositional bone grafting | Active comparator | Procedure: conventional interpositional bone graftingconventional interpositional bone grafting was done for patients with vertically atrophied mandibles (bilateral split mouth study) |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Edentulous posterior mandibular ridge with vertical loss of alveolar bone with remaining bone height (4-7 mm) above the mandibular canal
Key exclusion criteria (5 listed)
- • Smokers
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 |
|---|---|---|
| sandwich interpositional bone grafting computer guidedperforming the 2 vertical and the 1 horizontal osteotomies using a cutting patient specific guide and fixation of the vertically elevated bony segment after gap calculation using patient specific fixation guides | Procedure or surgery | computer guided sandwich interpositional bone grafting |
| conventional interpositional bone graftingperforming the conventional interpositional sandwich osteotomies free-hand and fixation of the mobilized bone segment free-hand | Procedure or surgery | conventional sandwich osteotomy interpositional bone grafting |
Primary outcome
amount of vertical bone gain
Time frame: 4 months
measure the amount of vertical bone gained after performing the interpositional sandwich osteotomy
1 secondary outcome
neurosensory affection
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
- 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. This study is not recruiting at the moment.
ahmed k mohamed, BDS principal investigator
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 sandwich interpositional bone grafting computer guided and conventional interpositional bone grafting in people with Bone Loss, run by Future University in Egypt 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 3 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
amount of vertical bone gain (time frame: 4 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 3 Jan 2023.