Ridge DeficencyNCT03533309
Accuracy of Computer Guided Versus Conventional Ridge Splitting of Horizontal Deficient in Maxillary Anterior Alveolar Ridge
A study testing Computer guided surgical cutting guide and Conventional alveolar ridge splitting in people with Ridge Deficency, run by Cairo University.
Trial summary
In patient with horizontal deficiency in alveolar ridge of the anterior maxilla, Dose computer Guided stent enhance the accuracy and clinical outcome vs conventional ridge splitting surgery???? Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Ridge Deficency
- What is being tested?
- Computer guided surgical cutting guide and Conventional alveolar ridge splitting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 30 Oct 2019
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Partial edentulous in the aesthetic zone.
- Patient with bucco-lingual bone width is 3 mm or greater but < 6mm
- Normal alveolar bone height
- Adequate oral hygiene
- Free of soft tissue or dental pathology
- Patients accepting to participate in the study
Who cannot join
- Patient medically compromised.
- Uncooperative patient.
- Poor oral hygiene and periodontal disease.
- Patients who smoked and pregnant women
- Systemic disease directly affecting bone healing
- Atrophic ridges (1.5 mm or less)
- History of radiotherapy \& treatment with bisphosphonates.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accuracy of Computer Guided Versus Conventional Ridge Splitting of Horizontal Deficient in Maxillary Anterior Alveolar Ridge (Randomized Clinical Trial)
In patient with horizontal deficiency in alveolar ridge of the anterior maxilla, Dose computer Guided stent enhance the accuracy and clinical outcome vs conventional ridge splitting surgery????
Read the detailed description
PICO P- Horizontal deficient alveolar ridge in Anterior Maxillary Region I- Computer guided surgical cutting guide C- Conventional alveolar ridge splitting O- Clinical outcome and radiographic outcomes Primary outcome: Accuracy In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting.
In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) Secondary outcome: Thickness of buccal cortical plate In both technique CBCT will performed and measuring the Both Buccal and palatal cortical bone in millimeter(mm)
- Conditions
- Ridge Deficency
- Being tested
- Computer guided surgical cutting guide, Conventional alveolar ridge splitting
- Keywords
- horizontal defect, Anterior maxillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided surgical cutting guideProcedure or surgery
comprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent
Conventional alveolar ridge splittingProcedure or surgery
comprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique.
| Study group | Role | What they receive |
|---|---|---|
| computer guided | Experimental | Group (A): comprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent.
. Receives: Procedure: Computer guided surgical cutting guide |
| conventional | Active comparator | Group (B) comprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique Receives: Procedure: Conventional alveolar ridge splitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting.
In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting.
In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm)
Measured: up to 4 months
Secondary outcomes (1)
Thickness of buccal cortical plate
In both technique CBCT will performed and measuring the Both Buccal and palatal cortical bone in millimeter(mm)
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Jul 2018 (estimated)
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge DeficencyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdalrahman Aburas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533309
- Sponsor's protocol ID
- 152018
- Status last verified
- May 2018
- First submitted
- 11 May 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Computer Guided Versus Conventional Ridge Splitting of Horizontal Deficient in Maxillary Anterior Alveolar Ridge (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03533309
- Acronym / sponsor ID
- 152018
- Conditions
- Ridge Deficency
- Keywords
- horizontal defect, Anterior maxillary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 23 May 2018 (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 patient with horizontal deficiency in alveolar ridge of the anterior maxilla, Dose computer Guided stent enhance the accuracy and clinical outcome vs conventional ridge splitting surgery????
Detailed description
PICO P- Horizontal deficient alveolar ridge in Anterior Maxillary Region I- Computer guided surgical cutting guide C- Conventional alveolar ridge splitting O- Clinical outcome and radiographic outcomes Primary outcome: Accuracy In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting.
In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) Secondary outcome: Thickness of buccal cortical plate In both technique CBCT will performed and measuring the Both Buccal and palatal cortical bone in millimeter(mm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer guided | Experimental | Procedure: Computer guided surgical cutting guideGroup (A): comprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent. . |
| conventional | Active comparator | Procedure: Conventional alveolar ridge splittingGroup (B) comprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Partial edentulous in the aesthetic zone.
- Patient with bucco-lingual bone width is 3 mm or greater but < 6mm
- Normal alveolar bone height
- Adequate oral hygiene
- Free of soft tissue or dental pathology
Key exclusion criteria (7 listed)
- Patient medically compromised.
- Uncooperative patient.
- Poor oral hygiene and periodontal disease.
- Patients who smoked and pregnant women
- Systemic disease directly affecting bone 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 surgical cutting guidecomprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent | Procedure or surgery | computer guided |
| Conventional alveolar ridge splittingcomprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique. | Procedure or surgery | conventional |
Primary outcome
Accuracy
Time frame: up to 4 months
In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting. In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting. In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm)
1 secondary outcome
Thickness of buccal cortical plate
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided surgical cutting guide and Conventional alveolar ridge splitting in people with Ridge Deficency, 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 6 inclusion and 7 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 24 May 2018. 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 abdelrahman akram aburass, master (00201288769226, abdalrahman.aburas@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: up to 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 24 May 2018.