Alveolar Bone LossNCT06329362
Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique
A study testing Minimally invasive implantation and Open flap procedure for ridge expansion. in people with Alveolar Bone Loss, run by The Royal College of Surgeons of Edinburgh at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Minimally invasive implantation and Open flap procedure for ridge expansion.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Jul 2023to Jul 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with atrophic posterior mandibular ridge with edentulous area 30-40 mm, minimum width 3-4 mm, and adequate height indicated for implant placement >9 mm.
- Patient with Bone density D2 and D3.
- Good general systemic condition.
- Committed patient to attend follow up appointment.
Who cannot join
- Patients with systemic diseases that may affect the healing process of hard or soft tissues (e.g., uncontrolled diabetes mellitus).
- Patient on medication that could hinder the normal healing process (e.g., steroids, immunosuppressant)
- Patients with intra-bony lesions or infections.
- Patient with bad habits (e.g. alcohol or Substance abuse).
- Patient who received head and neck radiotherapy or chemotherapy in the last 10 years.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Cairo, 35855
Bassem Emad, MDs, +201001113474, bassem_26@hotmail.com
Emad Deif, Prof, +201222331938, daif_emad@yahoo.com
Germany1 site, 1 recruiting
- Recruiting
Future Dental Academy GmbH
Flonheim, Rhineland-Palatinate, D-55237
Armin Nadjet, A.Prof, +4915115253692, nedjat@t-online.de
Rainer Zoppke, +491778339601, Rainer.Zoppke@champions-implants.com
About this study
Official title: Quantitative Assessment of Bone Comparing the Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique
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.
Read the 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:
- Bone density (D1 \& D4 for exclusion, while D2 \& D3 shall be included)
- 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
- Alveolar Bone Loss
- Being tested
- Minimally invasive implantation, Open flap procedure for ridge expansion.
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive implantationProcedure or surgery
Also called Champions Implant GmbH
Specially designed ridge splitting instrumentation by Champions Implant GmbH which is implant shaped expanders.
Open flap procedure for ridge expansion.Procedure or surgery
Also called Ridge splitting.
Mucoperiosteal elevation and ridge splitting using conventional ridge expanders.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Invasive Implant ridge splitting | Active comparator | Using minimally invasive implant placement in atrophied ridge without mucoperiosteal flap, and specially designed implant shaped expanders. Receives: Procedure: Minimally invasive implantation |
| conventional open flap ridge splitting implantation. | Active comparator | Using the conventional open flap technique with mucoperiosteal elevation to expose the ridge with the use of conventional bone expanders and chisels. Receives: Procedure: Open flap procedure for ridge expansion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability.
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.
.
Measured: immediate postoperative, 1, 2, and 3 months post operative.
CBCT assessment
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.
Measured: measurement points: preoperative, immediately postoperative, and 12 months postoperative, unless indicated otherwise e.g., Complications).
Secondary outcomes (2)
Postoperative Pain
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 deviation
Measured: to be completed by day 7 postoperative, describing the pain felt.
Operation Time
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.
Measured: Time of the procedure from the beginning to the end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start31 Jul 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal College of Surgeons of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassem Emad AbdElMoneim, The Royal College of Surgeons of Edinburgh
- Investigators
- Emad Deif, Prof., Study chair, Head of Oral and Maxillofacial Surgery Department - Faculty of Dentistry Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329362
- Sponsor's protocol ID
- 2-7-23
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Bone Comparing the Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique
- ClinicalTrials.gov ID
- NCT06329362
- Acronym / sponsor ID
- 2-7-23
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- The Royal College of Surgeons of EdinburghUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 25 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.
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:
- Bone density (D1 \& D4 for exclusion, while D2 \& D3 shall be included)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Invasive Implant ridge splitting | Active comparator | Procedure: Minimally invasive implantationUsing minimally invasive implant placement in atrophied ridge without mucoperiosteal flap, and specially designed implant shaped expanders. |
| conventional open flap ridge splitting implantation. | Active comparator | Procedure: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with atrophic posterior mandibular ridge with edentulous area 30-40 mm, minimum width 3-4 mm, and adequate height indicated for implant placement >9 mm.
- Patient with Bone density D2 and D3.
- Good general systemic condition.
- Committed patient to attend follow up appointment.
Key exclusion criteria (5 listed)
- Patients with systemic diseases that may affect the healing process of hard or soft tissues (e.g., uncontrolled diabetes mellitus).
- Patient on medication that could hinder the normal healing process (e.g., steroids, immunosuppressant)
- Patients with intra-bony lesions or infections.
- Patient with bad habits (e.g. alcohol or Substance abuse).
- Patient who received head and neck radiotherapy or chemotherapy in the last 10 years.
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 |
|---|---|---|
| Minimally invasive implantationAlso: Champions Implant GmbHSpecially designed ridge splitting instrumentation by Champions Implant GmbH which is implant shaped expanders. | Procedure or surgery | Minimal Invasive Implant ridge splitting |
| Open flap procedure for ridge expansion.Also: Ridge splitting.Mucoperiosteal elevation and ridge splitting using conventional ridge expanders. | Procedure or surgery | conventional open flap ridge splitting implantation. |
Primary outcome
Implant stability.
Time frame: 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
Time frame: 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.
2 secondary outcomes
Postoperative Pain
Time frame: to be completed by day 7 postoperative, describing the pain felt.
Operation Time
Time frame: Time of the procedure from the beginning to the end.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Emad Deif, Prof. study chair
Head of Oral and Maxillofacial Surgery Department - Faculty of Dentistry Cairo University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive implantation and Open flap procedure for ridge expansion. in people with Alveolar Bone Loss, run by The Royal College of Surgeons of Edinburgh at 2 sites in 2 countries.
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 4 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 26 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 2 sites in Egypt, Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bassem Hussein, MDs (+201001113474, bassem_26@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability. (time frame: immediate postoperative, 1, 2, and 3 months post operative.). The study lists 2 primary outcomes in all. 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 26 Mar 2024; AzTrials last refreshed its copy on 2 Nov 2026.