Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique
NCT ID: NCT06329362
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2023-07-31
2025-07-31
Brief Summary
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Detailed Description
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Explanation of the operative procedure and obtaining the participants consent. Comprehensive clinical examination and understanding of participants chief complains and needs will be carried out.
CBCT acquisition:
Cone Beam Computed Tomography (CBCT) scans for the participants will be Taken preoperatively to determine the following:
1. Bone density (D1 \& D4 for exclusion, while D2 \& D3 shall be included)
2. To confirm the ridge mapping indicating alveolar ridge class IV. (Where height is adequate \> 10mm, while width is "3-4 mm").
Planning the surgical procedure:
All planned surgical procedure will be carried out by main candidate under supervision.
Implant are planned to be placed (2 implants are placed in each segment "30-40 mm")
Surgical procedure:
Scrubbing and draping of the participants will be carried out in a standard fashion.
Local anesthesia (lidocaine 2%o,1/100000 adrenaline) Group A: Minimal Invasive Implant ridge splitting. A horizontal incision is made using fine end bur with high-speed hand piece deep from the edge of the ridge, passing down the cortical plate to the depth of the spongy bone, without mucoperiosteal elevation.
Using specially designed implant like bone expanders (Champions implants GmbH) to widen ridge with sequential application (which are 2.4, 2.8, 3.0, 3.3,3.8,4.3, and 5.3 mm in Diameter).
With each step the investigators shall carefully check the bone integrity and depth using calibrated probe.
By reaching the desired depth and width (till size 3.3 condensers and place 3.5 x 8 mm implants as a standard, using torque gage adjusted at 30-40 Newton's, that's to avoid pressure that might lead to initial resorption.
Closure of the incision line using interrupted suturing.
Group B: Triangular flap technique is used. With the horizontal component on the ridge and the vertical component posteriorly to avoid injury to the mental nerve, allowed by mucoperiosteal elevation to expose the target area.
2 vertical cuts on both ends to facilitate the ridge expansion, without the risk of crack or fracture of the buccal segment using conventional chisels till reaching the desired width that would accommodate the same implant diameter as for group A.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Minimal Invasive Implant ridge splitting
Using minimally invasive implant placement in atrophied ridge without mucoperiosteal flap, and specially designed implant shaped expanders.
Minimally invasive implantation
Specially designed ridge splitting instrumentation by Champions Implant GmbH which is implant shaped expanders.
conventional open flap ridge splitting implantation.
Using the conventional open flap technique with mucoperiosteal elevation to expose the ridge with the use of conventional bone expanders and chisels.
Open flap procedure for ridge expansion.
Mucoperiosteal elevation and ridge splitting using conventional ridge expanders.
Interventions
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Minimally invasive implantation
Specially designed ridge splitting instrumentation by Champions Implant GmbH which is implant shaped expanders.
Open flap procedure for ridge expansion.
Mucoperiosteal elevation and ridge splitting using conventional ridge expanders.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient with Bone density D2 and D3.
3. Good general systemic condition.
4. Committed patient to attend follow up appointment.
Exclusion Criteria
2. Patient on medication that could hinder the normal healing process (e.g., steroids, immunosuppressant)
3. Patients with intra-bony lesions or infections.
4. Patient with bad habits (e.g. alcohol or Substance abuse).
5. Patient who received head and neck radiotherapy or chemotherapy in the last 10 years.
ALL
Yes
Sponsors
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The Royal College of Surgeons of Edinburgh
OTHER
Responsible Party
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Bassem Emad AbdElMoneim
Oral and Maxillofacial Surgeon
Principal Investigators
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Emad Deif, Prof.
Role: STUDY_CHAIR
Head of Oral and Maxillofacial Surgery Department - Faculty of Dentistry Cairo University
Locations
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Faculty of Dentistry Cairo University
Cairo, , Egypt
Future Dental Academy GmbH
Flonheim, Rhineland-Palatinate, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2-7-23
Identifier Type: -
Identifier Source: org_study_id
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