Marginal Bone LossNCT03989193
Evaluation of Marginal Bone Loss Using Computer Guided Ridge Splitting Technique With Simultaneous Implant Placement.
A study testing Computer guided alveolar ridge splitting technique in people with Marginal Bone Loss and Computer Guided, run by Cairo University.
Trial summary
This clinical report describes a technique for ridge splitting, and gradual expansion in the maxilla with simultaneous implant placement with in the split ridge, with the preservation of the thin buccal plate of bone for proper blood supply. Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Marginal Bone Loss, Computer Guided, Ridge Splitting
- What is being tested?
- Computer guided alveolar ridge splitting technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 31 Jul 2020
- 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 18 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with thin maxillary ridge of 3 to 5 mm thickness of crestal alveolar bone (horizontal deficiency).
- Patients with free medical history and adequate proper oral hygiene.
- Patients of adequate alveolar bone height.
- Both genders males and females will be included.
Who cannot join
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
- Pregnant or nursing.
Show all 18Show fewer
- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
- Active infection or severe inflammation in the area intended for implant placement.
- Need of bone augmentation procedures at implant placement.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- any 'complex case' if implants had to be placed in the aesthetic zone defined as second to second maxillary premolars.
- Patients participating in other studies, if the present protocol could not be properly followed.
- Requiring only single implant-supported crowns.
Trial locations and contacts
No sites are listed yet.
Ragia Mounir, PhD contact
About this study
Official title: Evaluation of Marginal Bone Loss Using Computer Guided Ridge Splitting With Simultaneous Implant Placement Versus Conventional Technique (a Randomized Clinical Trial)
This clinical report describes a technique for ridge splitting, and gradual expansion in the maxilla with simultaneous implant placement with in the split ridge, with the preservation of the thin buccal plate of bone for proper blood supply.
Read the detailed description
All the procedures will perform under local anesthesia (mepivacain with levonordefrin). Horizontal Atrophic maxillary sectors will use for the development of the treatment sequence. All the patients will prepare initially with study models that permitted surgical and prosthetic planning as well as the non-strict surgical guide for intraoperative use. After application of conventional local anesthesia techniques, a full thickness incision 3 line pyramidal flap will be expose the defect ridge. The incision will extend to the next tooth or at least 5 mm more posterior from the end of the osteotomy indicated, securing direct observation of the alveolar crest.
With a direct view of the alveolar crest, if the ridge presented a width close to 1.5 mm, the ARST was performed immediately; if it presented less than 1.5 mm, then it was worn down with a diamond bur (low speed motor at 1800 rpm) to reduce the height, obtaining an improved alveolar crest width up to approximately 1.5 mm.
With this condition the bone splitting technique could be performed using the piezoelectric system (Piezotome2¨, Satelec Action, France), calibrating the device on the D1 setting and using profuse saline irrigation. The preparation sequence was begun with the CS3 insert until a total depth of 10 mm was achieved across the entire extension of the ridge. The procedure continued with the CS1 insert and finally the CS2 insert. The CS% insert was used in two patients with the possibility of widening the osteotomy segment; this sequence always achieved a complete extension in depth of application.
In the study group the vertical bone cuts through the cortical layer.
- At the distal end of the horizontal split: a vertical cut was made with the high-speed bur within the vicinity of the buccal plate of bone; for the start of the separation. With a full vertical depth of 13 mm. Final design of the splitting cut was (L-SHAPE) SPLIT The control group the vertical bone cuts through the cortical layer.
- At the distal and mesial end of the horizontal split: a vertical cut was made with the high-speed bur within the vicinity of the buccal plate of bone; for the start of the separation. With a full vertical depth of 13 mm corresponding and joining the previous vertical cut.
Using the expander to do the implants bed.-Preparation of the implant bed in the mesial end of the horizontal split using the spreading kit.-The final size spreader in the first implant osteotomy site with the first spreader in the second implant bed 3 mm apart. Dental implant placement. Placing the first implant in place while the separation kept preserved .placing the last spreader in the second implant osteotomy site. Bone deficiency is addressed by filling with osteoplastic material; a bio resorbing barrier membrane is arranged.
CBCT assessment For the calculation of marginal bone loss(MBL), the implant will use as a reference by adjusting the cross-sectional long axis in the center of the implant and bisecting it (showing the buccolingual and mesiodistal dimensions). On the cross-sectional view, a line will draw just parallel to the implant, starting at the crest of the labial plate of bone and ending at the apical level of the implant; height will recorded in millimeters. The same process was repeated from the palatal direction. The panoramic view (longitudinal cut) will utilized to calculate the mesial and distal bone heights in millimeters.
- Conditions
- Marginal Bone Loss, Computer Guided, Ridge Splitting
- Being tested
- Computer guided alveolar ridge splitting technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided alveolar ridge splitting techniqueDevice
The bone splitting technique could be performed using the piezoelectric system, calibrating the device on D1 setting and using profuse saline irrigation. The preparation sequence begins with CS3 insert until a total depth of 10mm was achieved across the entire extension of the ridge. The procedure continued with the CS1 insert and finally the CS2 insert.
The vertical bone cuts through the cortical layer: At the distal end of the horizontal split, a vertical cut will made with the high-speed bur within the vicinity of the buccal plate to start the separation, with a full vertical depth of 13 mm. Final design of the splitting cut was L-shaped split. At the distal and the mesial end of the horizontal split, a vertical cut was made with the high-speed bur for a full vertical depth of 13mm.
| Study group | Role | What they receive |
|---|---|---|
| Computer guided alveolar ridge splitting technique | Experimental | Computer guided alveolar ridge splitting using piezo electric device and a 3D printed surgical guide. An L shaped splitting pattern with one crestal and one distal cut will be performed. Receives: Device: Computer guided alveolar ridge splitting technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of marginal bone loss
the amount of marginal bone loss of thin narrow ridge after 6 months of splitting bone taking the implant as guide measured in mm determined on cone beam CT (panoramic and cross-sectional views).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Bone LossStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basel mohammed hamzah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989193
- Sponsor's protocol ID
- guidedsplit surgerymsc
- Status last verified
- Oct 2019
- First submitted
- 9 Jun 2019
- Last updated
- 22 Oct 2019
- 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 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Marginal Bone Loss Using Computer Guided Ridge Splitting With Simultaneous Implant Placement Versus Conventional Technique (a Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03989193
- Acronym / sponsor ID
- guidedsplit surgerymsc
- Conditions
- Marginal Bone Loss, Computer Guided, Ridge Splitting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 18 Jun 2019 (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.
This clinical report describes a technique for ridge splitting, and gradual expansion in the maxilla with simultaneous implant placement with in the split ridge, with the preservation of the thin buccal plate of bone for proper blood supply.
Detailed description
All the procedures will perform under local anesthesia (mepivacain with levonordefrin). Horizontal Atrophic maxillary sectors will use for the development of the treatment sequence. All the patients will prepare initially with study models that permitted surgical and prosthetic planning as well as the non-strict surgical guide for intraoperative use. After application of conventional local anesthesia techniques, a full thickness incision 3 line pyramidal flap will be expose the defect ridge. The incision will extend to the next tooth or at least 5 mm more posterior from the end of the osteotomy indicated, securing direct observation of the alveolar crest.
With a direct view of the alveolar crest, if the ridge presented a width close to 1.5 mm, the ARST was performed immediately; if it presented less than 1.5 mm, then it was worn down with a diamond bur (low speed motor at 1800 rpm) to reduce the height, obtaining an improved alveolar crest width up to approximately 1.5 mm.
With this condition the bone splitting technique could be performed using the piezoelectric system (Piezotome2¨, Satelec Action, France), calibrating the device on the D1 setting and using profuse saline irrigation. The preparation sequence was begun with the CS3 insert until a total depth of 10 mm was achieved across the entire extension of the ridge. The procedure continued with the CS1 insert and finally the CS2 insert. The CS% insert was used in two patients with the possibility of widening the osteotomy segment; this sequence always achieved a complete extension in depth of application.
In the study group the vertical bone cuts through the cortical layer.
- At the distal end of the horizontal split: a vertical cut was made with the high-speed bur within the vicinity of the buccal plate of bone; for the start of the separation. With a full vertical depth of 13 mm. Final design of the splitting cut was (L-SHAPE) SPLIT The control group the vertical bone cuts through the cortical layer.
- At the distal and mesial end of the horizontal split: a vertical cut was made with the high-speed bur within the vicinity of the buccal plate of bone; for the start of the separation. With a full vertical depth of 13 mm corresponding and joining the previous vertical cut.
Using the expander to do the implants bed.-Preparation of the implant bed in the mesial end of the horizontal split using the spreading kit.-The final size spreader in the first implant osteotomy site with the first spreader in the second implant bed 3 mm apart. Dental implant placement. Placing the first implant in place while the separation kept preserved .placing the last spreader in the second implant osteotomy site. Bone deficiency is addressed by filling with osteoplastic material; a bio resorbing barrier membrane is arranged.
CBCT assessment For the calculation of marginal bone loss(MBL), the implant will use as a reference by adjusting the cross-sectional long axis in the center of the implant and bisecting it (showing the buccolingual and mesiodistal dimensions). On the cross-sectional view, a line will draw just parallel to the implant, starting at the crest of the labial plate of bone and ending at the apical level of the implant; height will recorded in millimeters. The same process was repeated from the palatal direction. The panoramic view (longitudinal cut) will utilized to calculate the mesial and distal bone heights in millimeters.
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 alveolar ridge splitting technique | Experimental | Device: Computer guided alveolar ridge splitting techniqueComputer guided alveolar ridge splitting using piezo electric device and a 3D printed surgical guide. An L shaped splitting pattern with one crestal and one distal cut will be performed. |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with thin maxillary ridge of 3 to 5 mm thickness of crestal alveolar bone (horizontal deficiency).
- Patients with free medical history and adequate proper oral hygiene.
- Patients of adequate alveolar bone height.
- Both genders males and females will be included.
Key exclusion criteria (18 listed)
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
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 alveolar ridge splitting techniqueThe bone splitting technique could be performed using the piezoelectric system, calibrating the device on D1 setting and using profuse saline irrigation. The preparation sequence begins with CS3 insert until a total depth of 10mm was achieved across the entire extension of the ridge. The procedure continued with the CS1 insert and finally the CS2 insert. The vertical bone cuts through the cortical layer: At the distal end of the horizontal split, a vertical cut will made with the high-speed bur within the vicinity of the buccal plate to start the separation, with a full vertical depth of 13 mm. Final design of the splitting cut was L-shaped split. At the distal and the mesial end of the horizontal split, a vertical cut was made with the high-speed bur for a full vertical depth of 13mm. | Device | Computer guided alveolar ridge splitting technique |
Primary outcome
the amount of marginal bone loss
Time frame: 6 months
the amount of marginal bone loss of thin narrow ridge after 6 months of splitting bone taking the implant as guide measured in mm determined on cone beam CT (panoramic and cross-sectional views).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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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.
Ragia Mounir, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided alveolar ridge splitting technique in people with Marginal Bone Loss and Computer Guided, 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 4 inclusion and 18 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 22 Oct 2019. 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 Basel Omer, MSc (+201091181748, baselhamzah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the amount of marginal bone loss (time frame: 6 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 22 Oct 2019.