Dental ImplantNCT06333912
Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement
A study testing dental implant placement with ridge splitting. in people with Dental Implant, run by Alexandria University at 1 site in Egypt.
Trial summary
Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- dental implant placement with ridge splitting.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2023to 27 Feb 2024
- 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
- Patient with missing maxillary anteriors or premolars teeth.
- Tooth extraction at the implant sites was performed at least 4 months before the surgery.
- The bone width of the crestal one -third (3-5 mm) with sufficient bone height allowing for simultaneous implant placement.
- Free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement.
- With no history of any previous grafting surgeries at the area of interest.
Who cannot join
- Sever concavity of the alveolar ridge.
- Bad oral hygiene ( Silness-Löe index (score 2-3).
- Heavy smoker (smoke greater than or equal 25 cigarettes per day).
- Presence of acute infections or periapical lesions in adjacent teeth.
- Parafunctional habits.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Novel Ridge Splitting Guide Design in Comparison to Freehand With Simultaneous Implant Placement
Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency.
Read the detailed description
Two groups one treated with ridge splitting using guided surgery and the other one treated with freehand surgery and both groups had simultaneous dental implants the first one had guided placement and the other one was freehand.
- Conditions
- Dental Implant
- Being tested
- dental implant placement with ridge splitting.
- Keywords
- guided ridge splitting, atrophic maxilla, osseodensification drills.
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant placement with ridge splitting.Procedure or surgery
ridge splitting to increase bone width in atrophic maxilla with simultaneous implant placement
| Study group | Role | What they receive |
|---|---|---|
| study group treated with guided ridge splitting. | Experimental | virtual surgical planning using planning software Blue Sky Bio (BSB) and 3D printed surgical guide are fabricated to guide the ridge splitting procedure and implant drilling and placement. Receives: Procedure: dental implant placement with ridge splitting. |
| control group treated with conventional ridge splitting. | Active comparator | Freehand surgery is done including ridge splitting and implant plaement Receives: Procedure: dental implant placement with ridge splitting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the accuracy of guided surgery
superimposition of post-op cbct to the planned position to check the accuracy of implant positions.
Measured: one week
Secondary outcomes (1)
the bone-width increase between control and study group.
evaluation of two techniques of ridge splitting in increasing bone width.
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 posted27 Mar 2024
- Study start2 Aug 2023
- Primary completion29 Jan 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Elbayaa, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333912
- Sponsor's protocol ID
- ridgesplittingguided
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Novel Ridge Splitting Guide Design in Comparison to Freehand With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT06333912
- Acronym / sponsor ID
- ridgesplittingguided
- Conditions
- Dental Implant
- Keywords
- guided ridge splitting, atrophic maxilla, osseodensification drills.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 27 Mar 2024 (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.
Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency.
Detailed description
Two groups one treated with ridge splitting using guided surgery and the other one treated with freehand surgery and both groups had simultaneous dental implants the first one had guided placement and the other one was freehand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group treated with guided ridge splitting. | Experimental | Procedure: dental implant placement with ridge splitting.virtual surgical planning using planning software Blue Sky Bio (BSB) and 3D printed surgical guide are fabricated to guide the ridge splitting procedure and implant drilling and placement. |
| control group treated with conventional ridge splitting. | Active comparator | Procedure: dental implant placement with ridge splitting.Freehand surgery is done including ridge splitting and implant plaement |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient with missing maxillary anteriors or premolars teeth.
- Tooth extraction at the implant sites was performed at least 4 months before the surgery.
- The bone width of the crestal one -third (3-5 mm) with sufficient bone height allowing for simultaneous implant placement.
- Free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement.
- With no history of any previous grafting surgeries at the area of interest.
Key exclusion criteria (6 listed)
- Sever concavity of the alveolar ridge.
- Bad oral hygiene ( Silness-Löe index (score 2-3).
- Heavy smoker (smoke greater than or equal 25 cigarettes per day).
- Presence of acute infections or periapical lesions in adjacent teeth.
- Parafunctional habits.
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 |
|---|---|---|
| dental implant placement with ridge splitting.ridge splitting to increase bone width in atrophic maxilla with simultaneous implant placement | Procedure or surgery | control group treated with conventional ridge splitting., study group treated with guided ridge splitting. |
Primary outcome
Assessing the accuracy of guided surgery
Time frame: one week
superimposition of post-op cbct to the planned position to check the accuracy of implant positions.
1 secondary outcome
the bone-width increase between control and study group.
Time frame: 6 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 27 Mar 2024.
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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.
Mahmoud Elbayaa principal investigator
Alexandria 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 dental implant placement with ridge splitting. in people with Dental Implant, run by Alexandria 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 6 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 27 Mar 2024. 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?
Assessing the accuracy of guided surgery (time frame: one week). 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 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.