Bone DeformityPhase 3NCT06312384
The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation
A Phase 3 study testing 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation and conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation in people with Bone Deformity, run by Mansoura University at 1 site in Egypt.
Trial summary
Evaluate the impact of using 3D surgical template with guided bone regeneration technique on the contour of bone augmentation in patients with horizontal labial ridge defect and simultaneous implantation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Deformity
- What is being tested?
- 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation and conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to Jun 2024
- Phase
- Phase 3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients between the ages of 18 and 65 with edentulous ridge and seek for implant replacement.
- In the anterior region, there is a labial bone defect.
- Patients need the surgery in the first place to compensate for bone loss around implant.
Who cannot join
- Systemic disorders that are out of control.
- Heavy smokers (those who smoke more than 20 per day).
- Women who are pregnant or nursing.
- Thin gingival bio-type.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patients With Labial Alveolar Ridge Defect and Simultaneous Implantation
Evaluate the impact of using 3D surgical template with guided bone regeneration technique on the contour of bone augmentation in patients with horizontal labial ridge defect and simultaneous implantation.
Read the detailed description
Because adequate bone wrapping around the implant is critical for long-term effectiveness of dental implant treatment, bone augmentation in the bone defect area is required to repair the width and height of the alveolar bone, as bone resorption occurs following tooth extraction.
Many bone augmentation techniques, such as onlay block grafting, bone splitting, distraction osteogenesis, and guided bone regeneration, are currently accessible in clinics (GBR). Surgical options vary depending on the severity of the bone deformity. GBR is a bone augmentation technique that has more evidence-based medicine support and therapeutic applications, as well as the benefits of less surgical stress and low technical sensitivity.
Establishing aesthetics and guaranteeing long-term success in implant therapy can be challenging. Long-term stable implant success has been linked to the presence of more than 2mm labial graft thickness, and appropriate labial graft thickness is essential to preserve crestal bone level and prevent marginal soft tissue recession. According to a meta-analysis of 15 randomized-controlled trials, the estimated mean (SD) bone resorption for GBR in lateral ridge augmentation throughout the 6-month healing period was 1.22-0.28 mm. As a result, a 3.5 mm thickness of labial graft at all levels may be necessary following wound closure to compensate for potential graft loss.
Traditional bone augmentation is often dependent on the operator's skill, therefore virtually digital guided bone regeneration (GBR) process offers the digital options for precise and controllable bone augmentation in the field of oral implantology .
Specific aim: to compare the contour of bone augmentation (peri-implant bone volume) between various (GBR) procedures in patients with lateral alveolar ridge defect and simultaneous implantation.
Hypothesis: patients with lateral alveolar ridge defect and simultaneous implantation subjected to a 3D printing surgical template with GBR are associated with radiographic evidence of more labial graft thickness and volume stability after six months post-surgical than patients with conventional GBR protocol.
- Conditions
- Bone Deformity
- Being tested
- 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation, conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation
- Keywords
- 3D surgical template, guided bone regeneration , the contour of bone augmentation ,horizontal labial ridge defect and simultaneous implantation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous ImplantationProcedure or surgery
a two-piece tooth-supported surgical template will fabricated through 3D printing technology before surgery base on the digital simulation of bone graft contour.Sticky bone will placed into the defect under the guidance of the template to form customized sticky bone and will be covered with collagen membrane.
conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous ImplantationProcedure or surgery
The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane.
| Study group | Role | What they receive |
|---|---|---|
| study | Active comparator | The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied, in this group 3D surgical template will be applied which consist of a two-piece tooth-supported surgical template will fabricated through 3D printing technology before surgery base on the digital simulation of bone graft contour. Receives: Procedure: 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation |
| control | Active comparator | The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied [conventional guided tissue regeneration]. Receives: Procedure: conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Radiographic assessment for all patients underwent Cone beam computed tomography (CBCT) scans
The postoperative CBCT DICOM images were converted to STL files and overlaid over the preoperative CBCT.The thickness of the labial bone graft was measured from the labial outline of the bone graft to the implant as a result of the procedure. (T0-T5) Perpendicular to the simulated implant in the bucco-oral cross-sectional picture. The distance (width in millimeter) between the implant and the labial contour of the graft, which indicated the thickness of the labial bone graft, was measured at the implant shoulder (T0), as well as at 1, 2, 3, 4, and 5 mm apical to the implant shoulder (T1-T5).
For each site, the standard deviation of T0, T1, and T2 (SDC) was calculated, which represents the uniformity of the graft contour in the coronal area.
Measured: baseline, immediately after and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jul 2022
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone DeformityStudies of the same condition, open and under way.
- More trials run by Mansoura 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 \[Control group\]: The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied \[conventional GTR\]. Group 2 \[Study group\]: The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied, in this group 3D surgical template will be applied.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312384
- Sponsor's protocol ID
- A04080622
- Status last verified
- Dec 2023
- First submitted
- 29 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang M, Zhang X, Li Y, Mo A. The Influence of Different Guided Bone Regeneration Procedures on the Contour of Bone Graft after Wound Closure: A Retrospective Cohort Study. Materials (Basel). 2021 Jan 27;14(3):583. doi: 10.3390/ma14030583.
PubMed 33513735
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patients With Labial Alveolar Ridge Defect and Simultaneous Implantation
- ClinicalTrials.gov ID
- NCT06312384
- Acronym / sponsor ID
- A04080622
- Conditions
- Bone Deformity
- Keywords
- 3D surgical template, guided bone regeneration , the contour of bone augmentation ,horizontal labial ridge defect and simultaneous implantation.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 15 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.
Evaluate the impact of using 3D surgical template with guided bone regeneration technique on the contour of bone augmentation in patients with horizontal labial ridge defect and simultaneous implantation.
Detailed description
Because adequate bone wrapping around the implant is critical for long-term effectiveness of dental implant treatment, bone augmentation in the bone defect area is required to repair the width and height of the alveolar bone, as bone resorption occurs following tooth extraction.
Many bone augmentation techniques, such as onlay block grafting, bone splitting, distraction osteogenesis, and guided bone regeneration, are currently accessible in clinics (GBR). Surgical options vary depending on the severity of the bone deformity. GBR is a bone augmentation technique that has more evidence-based medicine support and therapeutic applications, as well as the benefits of less surgical stress and low technical sensitivity.
Establishing aesthetics and guaranteeing long-term success in implant therapy can be challenging. Long-term stable implant success has been linked to the presence of more than 2mm labial graft thickness, and appropriate labial graft thickness is essential to preserve crestal bone level and prevent marginal soft tissue recession. According to a meta-analysis of 15 randomized-controlled trials, the estimated mean (SD) bone resorption for GBR in lateral ridge augmentation throughout the 6-month healing period was 1.22-0.28 mm. As a result, a 3.5 mm thickness of labial graft at all levels may be necessary following wound closure to compensate for potential graft loss.
Traditional bone augmentation is often dependent on the operator's skill, therefore virtually digital guided bone regeneration (GBR) process offers the digital options for precise and controllable bone augmentation in the field of oral implantology .
Specific aim: to compare the contour of bone augmentation (peri-implant bone volume) between various (GBR) procedures in patients with lateral alveolar ridge defect and simultaneous implantation.
Hypothesis: patients with lateral alveolar ridge defect and simultaneous implantation subjected to a 3D printing surgical template with GBR are associated with radiographic evidence of more labial graft thickness and volume stability after six months post-surgical than patients with conventional GBR protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1 [Control group]: The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied [conventional GTR]. Group 2 [Study group]: The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied, in this group 3D surgical template will be applied.
| Arm | Type | Receives |
|---|---|---|
| study | Active comparator | Procedure: 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous ImplantationThe defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied, in this group 3D surgical template will be applied which consist of a two-piece tooth-supported surgical template will fabricated through 3D printing technology before surgery base on the digital simulation of bone graft contour. |
| control | Active comparator | Procedure: conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous ImplantationThe defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane will be applied [conventional guided tissue regeneration]. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy patients between the ages of 18 and 65 with edentulous ridge and seek for implant replacement.
- In the anterior region, there is a labial bone defect.
- Patients need the surgery in the first place to compensate for bone loss around implant.
Key exclusion criteria (4 listed)
- Systemic disorders that are out of control.
- Heavy smokers (those who smoke more than 20 per day).
- Women who are pregnant or nursing.
- Thin gingival bio-type.
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 |
|---|---|---|
| 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantationa two-piece tooth-supported surgical template will fabricated through 3D printing technology before surgery base on the digital simulation of bone graft contour.Sticky bone will placed into the defect under the guidance of the template to form customized sticky bone and will be covered with collagen membrane. | Procedure or surgery | study |
| conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous ImplantationThe defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane. | Procedure or surgery | control |
Primary outcome
Change in Radiographic assessment for all patients underwent Cone beam computed tomography (CBCT) scans
Time frame: baseline, immediately after and 6 months after surgery
The postoperative CBCT DICOM images were converted to STL files and overlaid over the preoperative CBCT.The thickness of the labial bone graft was measured from the labial outline of the bone graft to the implant as a result of the procedure. (T0-T5) Perpendicular to the simulated implant in the bucco-oral cross-sectional picture. The distance (width in millimeter) between the implant and the labial contour of the graft, which indicated the thickness of the labial bone graft, was measured at the implant shoulder (T0), as well as at 1, 2, 3, 4, and 5 mm apical to the implant shoulder (T1-T5). For each site, the standard deviation of T0, T1, and T2 (SDC) was calculated, which represents the uniformity of the graft contour in the coronal area.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 33513735Wang M, Zhang X, Li Y, Mo A. The Influence of Different Guided Bone Regeneration Procedures on the Contour of Bone Graft after Wound Closure: A Retrospective Cohort Study. Materials (Basel). 2021 Jan 27;14(3):583. doi: 10.3390/ma14030583.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation and conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation in people with Bone Deformity, run by Mansoura University at 1 site in Egypt.
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 4 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 15 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 1 site in Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Radiographic assessment for all patients underwent Cone beam computed tomography (CBCT) scans (time frame: baseline, immediately after and 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312384, which also lists 1 linked publication.
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 15 Mar 2024.