Computer Guided Alveolar Bone AugmentaionNCT05556330
Computer Guided Versus Free Hand Horizontal Ridge Augmentation in Anterior Mandible.
A study testing computer guided autogenous cortical shell technique in people with Computer Guided Alveolar Bone Augmentaion, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment of horizontal ridge augmentation in anterior mandible using computer guided autogenous cortical shell technique versus free hand technique: randomized clinical trial Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Computer Guided Alveolar Bone Augmentaion
- What is being tested?
- computer guided autogenous cortical shell technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to Sep 2023
- 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 ranges from 25-55 years. No sex predilection.
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- Edentulous anterior mandible with horizontally deficient alveolar ridge that is less than 3mm width.
- Normal vertical dimension with normal inter-arch space.
- The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent 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.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Giza, 12613
Mohamed Mounir Shaker, PHD, 01001505798, mohamed.mounir@dentistry.cu.edu.eg
About this study
Official title: Assessment of Horizontal Ridge Augmentation in Anterior Mandible Using Computer Guided Autogenous Cortical Shell Technique Versus Free Hand Technique: Randomized Clinical Trial
Assessment of horizontal ridge augmentation in anterior mandible using computer guided autogenous cortical shell technique versus free hand technique:
randomized clinical trial
Read the detailed description
patients with deficient anterior mandible were included in this study where control group patients received free hand harvesting and fixation of cortical shells from the symphysis, while the study group patients received the same protocol using 2 patient specific guides (psg) the first guide used for safe and accurate graft harvesting with the proposed dimensions while the second guide used for shell fixation leaving the desired gap with the recipient site that was filled with a particulate mix of xeno and auto grafts .the first guide was fixed in place allowing for accurate harvesting of the cortical shell of desired dimensions from the symphysis Then; the harvested shell was fixed to the second guide outside the patients mouth using micro screws And this fixation guide was finally secured to its final position using two interlocking wings to lock into the first guide at the surgical site as a verification step for the accuracy of the whole procedure. Finally, the 2 guides were removed after shell fixation to the recipient site in a through and through manner st the proposed planed position.
- Being tested
- computer guided autogenous cortical shell technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer guided autogenous cortical shell techniqueProcedure or surgery
computer guided autogenous cortical shell technique
| Study group | Role | What they receive |
|---|---|---|
| horizontal ridge augmentation by computer guided autogenous cortical shell technique | Experimental | Not described Receives: Procedure: computer guided autogenous cortical shell technique |
| horizontal ridge augmentation by free hand autogenous cortical shell technique | Active comparator | Not described Receives: Procedure: computer guided autogenous cortical shell technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge horizontal bone gain
amount of horizontal bone gain in millimeters measured by cbct
Measured: one day
Secondary outcomes (1)
Alveolar ridge horizontal augmentation accuracy in 3D space
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Jun 2022
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computer Guided Alveolar Bone AugmentaionStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Ahmed Sakr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556330
- Sponsor's protocol ID
- 13522
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 27 Sep 2022
- 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 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Horizontal Ridge Augmentation in Anterior Mandible Using Computer Guided Autogenous Cortical Shell Technique Versus Free Hand Technique: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05556330
- Acronym / sponsor ID
- 13522
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 27 Sep 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.
Assessment of horizontal ridge augmentation in anterior mandible using computer guided autogenous cortical shell technique versus free hand technique:
randomized clinical trial
Detailed description
patients with deficient anterior mandible were included in this study where control group patients received free hand harvesting and fixation of cortical shells from the symphysis, while the study group patients received the same protocol using 2 patient specific guides (psg) the first guide used for safe and accurate graft harvesting with the proposed dimensions while the second guide used for shell fixation leaving the desired gap with the recipient site that was filled with a particulate mix of xeno and auto grafts .the first guide was fixed in place allowing for accurate harvesting of the cortical shell of desired dimensions from the symphysis Then; the harvested shell was fixed to the second guide outside the patients mouth using micro screws And this fixation guide was finally secured to its final position using two interlocking wings to lock into the first guide at the surgical site as a verification step for the accuracy of the whole procedure. Finally, the 2 guides were removed after shell fixation to the recipient site in a through and through manner st the proposed planed position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| horizontal ridge augmentation by computer guided autogenous cortical shell technique | Experimental | Procedure: computer guided autogenous cortical shell technique |
| horizontal ridge augmentation by free hand autogenous cortical shell technique | Active comparator | Procedure: computer guided autogenous cortical shell technique |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Age ranges from 25-55 years. No sex predilection.
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 |
|---|---|---|
| computer guided autogenous cortical shell techniquecomputer guided autogenous cortical shell technique | Procedure or surgery | horizontal ridge augmentation by computer guided autogenous cortical shell technique, horizontal ridge augmentation by free hand autogenous cortical shell technique |
Primary outcome
Alveolar ridge horizontal bone gain
Time frame: one day
amount of horizontal bone gain in millimeters measured by cbct
1 secondary outcome
Alveolar ridge horizontal augmentation accuracy in 3D space
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
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 computer guided autogenous cortical shell technique in people with Computer Guided Alveolar Bone Augmentaion, 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 27 Sep 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?
Contact Mohamed Ibrahim Sakr, Bachelor (01097891973, mohamedsakr@dentstry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar ridge horizontal bone gain (time frame: one day). 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 27 Sep 2022.