Edentulous PatientsNCT03748615
The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
A study testing Computer Guided ridge splitting in posterior mandible in people with Edentulous Patients and Atrophic Posterior Mandible With Insufficient Width, run by Cairo University.
Trial summary
The use of implants has significantly increased prosthetic options for edentulous patient. However, implant placement in the Posterior mandibular region is often hampered significantly by insufficient atrophic width limitations Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Edentulous Patients, Atrophic Posterior Mandible With Insufficient Width
- What is being tested?
- Computer Guided ridge splitting in posterior mandible
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2018to 20 Nov 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with edentulous posterior area of the mandible insufficient width less than 5m, Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement.
Who cannot join
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems.
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Trial locations and contacts
No sites are listed yet.
About this study
The use of implants has significantly increased prosthetic options for edentulous patient. However, implant placement in the Posterior mandibular region is often hampered significantly by insufficient atrophic width limitations
Read the detailed description
Ridge splitting technique causes lateral ridge expansion which creates new implant bed by longitudinal osteotomy, positioning buccal cortex laterally. The buccal cortex is positioned laterally to create space between buccal and lingual cortical plates, which is filled by an endosseous implant with or without any graft material limitations.
Ridge split technique is a very predictable procedure that can achieve substantial gains in horizontal ridge width of the edentulous posterior mandible without associated morbidity. This technique allows the clinician to augment the site and do the implant insertion in a single stage surgery, shortening the healing period drastically.
In the conventional ridge splitting technique, a complete flap is raised to allow adequate visibility of the bone defect which can result in disturbance of vascular supply and increase bone resorption rates. In this case report, a new innovative computer guided closed alveolar ridge splitting flapless technique has been advocated to avoid this disruption.
As Guided implant placement showed a statistically superior accuracy when they are compared with freehand placement after guided osteotomy Computer guided ridge splitting may have a superior accuracy than the freehand ridge splitting and may reduce the time of surgery, healing period and post-operative pain.
- Being tested
- Computer Guided ridge splitting in posterior mandible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Guided ridge splitting in posterior mandibleDevice
The computer guided ridge splitting for patients with atrophic posterior mandible and with residual bone width at least 3 to 5mm of residual ridge.
The selected patients will be informed of the nature of the research work and informed consent will be signed.
Radiographic examination included preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis.
Computer surgical guides are fabricated for partially edentulous patients using teeth and tissue as support for the guide.
The same surgeon performed all surgeries. All surgical procedures were performed under strict aseptic conditions, all patients received nerve block local anesthesia (Articaine 4% 1:100 000 epinephrine).
A crestal incision is made using No. 15 blade extending over the posterior mandible using computer guided surgical stent.
no flap elevation .
| Study group | Role | What they receive |
|---|---|---|
| Computer Guided ridge splitting in posterior mandible | Experimental | fabrication of a computer aided surgical guide and performing ridge splitting in posterior mandible using piezosurgery Receives: Device: Computer Guided ridge splitting in posterior mandible |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of the procedure ,pain and edema
the time of the procedure will be measured numerical using visual analogue scan
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start20 Nov 2018 (estimated)
- Primary completion20 Sep 2019 (estimated)
- Study completion20 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous PatientsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walla farhat mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748615
- Sponsor's protocol ID
- CairoUimplant master course
- Status last verified
- Nov 2018
- First submitted
- 14 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
- ClinicalTrials.gov ID
- NCT03748615
- Acronym / sponsor ID
- CairoUimplant master course
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (estimated)
- Primary completion
- 20 Sep 2019 (estimated)
- Study completion
- 20 Nov 2019 (estimated)
- First posted
- 21 Nov 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.
The use of implants has significantly increased prosthetic options for edentulous patient. However, implant placement in the Posterior mandibular region is often hampered significantly by insufficient atrophic width limitations
Detailed description
Ridge splitting technique causes lateral ridge expansion which creates new implant bed by longitudinal osteotomy, positioning buccal cortex laterally. The buccal cortex is positioned laterally to create space between buccal and lingual cortical plates, which is filled by an endosseous implant with or without any graft material limitations.
Ridge split technique is a very predictable procedure that can achieve substantial gains in horizontal ridge width of the edentulous posterior mandible without associated morbidity. This technique allows the clinician to augment the site and do the implant insertion in a single stage surgery, shortening the healing period drastically.
In the conventional ridge splitting technique, a complete flap is raised to allow adequate visibility of the bone defect which can result in disturbance of vascular supply and increase bone resorption rates. In this case report, a new innovative computer guided closed alveolar ridge splitting flapless technique has been advocated to avoid this disruption.
As Guided implant placement showed a statistically superior accuracy when they are compared with freehand placement after guided osteotomy Computer guided ridge splitting may have a superior accuracy than the freehand ridge splitting and may reduce the time of surgery, healing period and post-operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computer Guided ridge splitting in posterior mandible | Experimental | Device: Computer Guided ridge splitting in posterior mandiblefabrication of a computer aided surgical guide and performing ridge splitting in posterior mandible using piezosurgery |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with edentulous posterior area of the mandible insufficient width less than 5m, Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement.
Key exclusion criteria (5 listed)
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems.
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
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 ridge splitting in posterior mandibleThe computer guided ridge splitting for patients with atrophic posterior mandible and with residual bone width at least 3 to 5mm of residual ridge. The selected patients will be informed of the nature of the research work and informed consent will be signed. Radiographic examination included preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis. Computer surgical guides are fabricated for partially edentulous patients using teeth and tissue as support for the guide. The same surgeon performed all surgeries. All surgical procedures were performed under strict aseptic conditions, all patients received nerve block local anesthesia (Articaine 4% 1:100 000 epinephrine). A crestal incision is made using No. 15 blade extending over the posterior mandible using computer guided surgical stent. no flap elevation . | Device | Computer Guided ridge splitting in posterior mandible |
Primary outcome
Time of the procedure ,pain and edema
Time frame: 4 month
the time of the procedure will be measured numerical using visual analogue scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Guided ridge splitting in posterior mandible in people with Edentulous Patients and Atrophic Posterior Mandible With Insufficient Width, 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 3 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: status not confirmed, as of the sponsor's last update on 21 Nov 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 wallaa farahat mohamed, bds (01069543488, loulu_90_ooo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of the procedure ,pain and edema (time frame: 4 month). 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 21 Nov 2018.