Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique
- Conditions
- Alveolar Bone Loss
- Interventions
- Procedure: Minimally invasive implantationProcedure: Open flap procedure for ridge expansion.
- Registration Number
- NCT06329362
- Lead Sponsor
- The Royal College of Surgeons of Edinburgh
- Brief Summary
The goal of this clinical trial is to compare implant stability, and crestal bone loss, when using minimal invasive ridge splitting versus convenient open flap technique. The main question is Does Minimal Invasive Implant ridge splitting ("transmucosal" without flap) influence the implant stability and crystal bone loss, when compared with the conventional open flap techniques? Researchers will compare Group A: Minimal Invasive Implant ridge splitting and Group B: Triangular flap technique is used to see if there is significant difference between the two groups when measuring implant stability, and crestal bone density.
- Detailed Description
Diagnostic stage:
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Minimal Invasive Implant ridge splitting Minimally invasive implantation Using minimally invasive implant placement in atrophied ridge without mucoperiosteal flap, and specially designed implant shaped expanders. conventional open flap ridge splitting implantation. Open flap procedure for ridge expansion. Using the conventional open flap technique with mucoperiosteal elevation to expose the ridge with the use of conventional bone expanders and chisels.
- Primary Outcome Measures
Name Time Method Implant stability. immediate postoperative, 1, 2, and 3 months post operative. Implant Stability Quotient (ISQ) evaluation via Ostell device for implant stability measurement, it measures on a scale from 1 to 100 and is a measure of the stability of an implant, less than 60 indicates low stability, 60-69 indicates medium stability, 70 and more indicates high stability.
Method of aggregation: Mean and standard deviation.
.CBCT assessment measurement points: preoperative, immediately postoperative, and 12 months postoperative, unless indicated otherwise e.g., Complications). Bone density at the implant site in House field unit. A Hounsfield unit reading of 1250 and above indicates D1 bone. A Hounsfield reading between 850 to 1250 units is indicative of D2 bone. A Hounsfield reading between 350 and 850 units is indicative of type D3 bone. A Hounsfield reading between 150 and 350 units is indicative of D4 bone. Method of aggregation: Mean and standard deviation.
- Secondary Outcome Measures
Name Time Method Postoperative Pain to be completed by day 7 postoperative, describing the pain felt. Specific measurement variable: Visual Analogue Scale (VAS Scale), scale chart to be completed by the patient from 0-10 where 0 means no pain and 10 means worst of pain.
Participant -level analysis: Final value. Method of aggregation: Mean and standard deviationOperation Time Time of the procedure from the beginning to the end. Specific measurement variable: operating time in minutes and seconds from the beginning to the end of the procedure.
Participant-level analysis: Final value. Method of aggregation: Mean and standard deviation.
Trial Locations
- Locations (2)
Future Dental Academy GmbH
🇩🇪Flonheim, Rheinland - Pfalz, Germany
Faculty of Dentistry Cairo University
🇪🇬Cairo, Egypt