Vertical Deficeny of Posterior MandibleNCT05512078
Assessment of Vertical Ridge Augmentation for Posterior Mandible by Computer Guided Onlay vs Free Hand Onlay Graft
A study testing bone positioning surgical guide in people with Vertical Deficeny of Posterior Mandible, run by Cairo University at 1 site in Egypt.
Trial summary
for patients with vertical bone loss in posterior mandible area......invistigators use chin blocks for vertical augmentation...i compare between using guide for positiong the block with the desired position using special surgical guide versus position the block with free hand technique Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Vertical Deficeny of Posterior Mandible
- What is being tested?
- bone positioning surgical guide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range from 25-55 years. No sex predilection. 8
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- Edentulous bilateral posterior mandible with vertically deficient alveolar ridge that is less than 7mm measured from the crest of the alveolar ridge to the inferior alveolar canal.
- Normal vertical dimension with normal inter-arch space.
- The minimum number of missing teeth in the posterior mandible alveolar ridge is two adjacent posterior teeth.
Who cannot join
- • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
- Previous grafting procedures in the edentulous area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Vertical Ridge Augmentation for Posterior Mandible Using Computer Guided Onlay Versus Free Hand Onlay Grafting Procedures: A Randomized Clinical Split Mouth Trial
for patients with vertical bone loss in posterior mandible area......invistigators use chin blocks for vertical augmentation...i compare between using guide for positiong the block with the desired position using special surgical guide versus position the block with free hand technique
Read the detailed description
- The CBCT scan images will be imported into a computer software (Mimics15, Materialise, Leuven, Belgium) for the reformatting of the retrieved DICOM images and reconstruction of three-dimensional virtual model of both the donor and recipient sites.
The virtual model will be imported into a second software (3-Matic, Materialise, Leuven, Belgium) specialized in designing medical devices and surgical stents.
- The 1st surgical guide will be designed to guide the harvesting of two bilateral bone blocks ensuring that each block is designed with the superior osteotomy line more than 5 mm away from the apices of the anterior teeth and the inferior line more than 5 mm away from the inferior border of the mandible and the medial line 5 mm away from the symphysis, with two screw holes in the symphysis area to fixate the guide to the bone.
- The 2nd surgical guide will be designed to guide the fixation of the onlay graft, the design will include two screw holes placed with minimum 2mm safety margin below the inferior alveolar canal to fixate the guide in place, and two more screw holes placed supracrestal to fixate the graft to the guide superiorly.
- Finally, the surgical guide will be printed using fused deposition modeling technology with acrylonitrile butadiene styrene (ABS) plastic material. All guides will be sterilized using 2.4% gluteraldehyde for 12 hours prior to the surgery. All surgeries will be performed by the same surgeon.
- Conditions
- Vertical Deficeny of Posterior Mandible
- Being tested
- bone positioning surgical guide
- Keywords
- vertical posterior mandible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone positioning surgical guideProcedure or surgery
Also called bone fixation surgical guide
patient specific surgical positioning guide made from acrylonitrile butadiene styrene (ABS) plastic material.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | patient specific surgical positioning guide Receives: Procedure: bone positioning surgical guide |
| control | Active comparator | onlay bone graft Receives: Procedure: bone positioning surgical guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge vertical bone height
measuring alveolar height bone gain using cbct
Measured: 4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Dec 2020
- Primary completion1 Dec 2021
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertical Deficeny of Posterior MandibleStudies 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
- Single group
- Model description
- patients with bilateral vertical bone loss in posterior mandible
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hamid Khorshed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512078
- Sponsor's protocol ID
- omf10721
- Status last verified
- Aug 2022
- First submitted
- 23 Jul 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vertical Ridge Augmentation for Posterior Mandible Using Computer Guided Onlay Versus Free Hand Onlay Grafting Procedures: A Randomized Clinical Split Mouth Trial
- ClinicalTrials.gov ID
- NCT05512078
- Acronym / sponsor ID
- omf10721
- Conditions
- Vertical Deficeny of Posterior Mandible
- Keywords
- vertical posterior mandible
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- Aug 2022 (estimated)
- First posted
- 23 Aug 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.
for patients with vertical bone loss in posterior mandible area......invistigators use chin blocks for vertical augmentation...i compare between using guide for positiong the block with the desired position using special surgical guide versus position the block with free hand technique
Detailed description
- The CBCT scan images will be imported into a computer software (Mimics15, Materialise, Leuven, Belgium) for the reformatting of the retrieved DICOM images and reconstruction of three-dimensional virtual model of both the donor and recipient sites.
The virtual model will be imported into a second software (3-Matic, Materialise, Leuven, Belgium) specialized in designing medical devices and surgical stents.
- The 1st surgical guide will be designed to guide the harvesting of two bilateral bone blocks ensuring that each block is designed with the superior osteotomy line more than 5 mm away from the apices of the anterior teeth and the inferior line more than 5 mm away from the inferior border of the mandible and the medial line 5 mm away from the symphysis, with two screw holes in the symphysis area to fixate the guide to the bone.
- The 2nd surgical guide will be designed to guide the fixation of the onlay graft, the design will include two screw holes placed with minimum 2mm safety margin below the inferior alveolar canal to fixate the guide in place, and two more screw holes placed supracrestal to fixate the graft to the guide superiorly.
- Finally, the surgical guide will be printed using fused deposition modeling technology with acrylonitrile butadiene styrene (ABS) plastic material. All guides will be sterilized using 2.4% gluteraldehyde for 12 hours prior to the surgery. All surgeries will be performed by the same surgeon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients with bilateral vertical bone loss in posterior mandible
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: bone positioning surgical guidepatient specific surgical positioning guide |
| control | Active comparator | Procedure: bone positioning surgical guideonlay bone graft |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range from 25-55 years. No sex predilection. 8
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- Edentulous bilateral posterior mandible with vertically deficient alveolar ridge that is less than 7mm measured from the crest of the alveolar ridge to the inferior alveolar canal.
- Normal vertical dimension with normal inter-arch space.
- The minimum number of missing teeth in the posterior mandible alveolar ridge is two adjacent posterior teeth.
Key exclusion criteria (2 listed)
- • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
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 |
|---|---|---|
| bone positioning surgical guideAlso: bone fixation surgical guidepatient specific surgical positioning guide made from acrylonitrile butadiene styrene (ABS) plastic material. | Procedure or surgery | control, intervention |
Primary outcome
Alveolar ridge vertical bone height
Time frame: 4months
measuring alveolar height bone gain using cbct
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone positioning surgical guide in people with Vertical Deficeny of Posterior Mandible, 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 2 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 Aug 2022. 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?
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?
Alveolar ridge vertical bone height (time frame: 4months). 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 Aug 2022.