Bone Loss, AlveolarNCT06559605
Evaluation of Bone Gain Using Customized 3D Zirconia Barrier Versus Titanium Mesh
A study testing zirconia barrier and titanium mesh in people with Bone Loss, Alveolar, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of clinical and radiographical amount of bone gained using customized 3D printed zirconia barrier compared to titanium mesh in combined ridge defect at the esthetic zone. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Alveolar
- What is being tested?
- zirconia barrier and titanium mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 22 May 2024to 22 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 20-70 years.
- Bone width less than 4mm
- Vertical bone height less than 9mm
- Periodontally sound neighboring teeth
- Patients with sound vertical occlusal bite dimension
- Good oral hygiene (full mouth plaque control record [PCR] < 25%,full mouth bleeding on probing (BOP) < 25% .
- Patients demonstrating understanding and commitment to the post-operative care regime and the study follow up timeline.
- Good general health (including participants with well-controlled systemic disease)
Who cannot join
- Pathological lesions (abscess-cyst-acute infection) in the defect site
- Systemic diseases that would interfere with bone metabolism
- Uncontrolled diabetic patients
- Ongoing treatment or a history of recent chemotherapy or radiotherapy
- Poor oral hygiene after hygienic phase (Plaque control record over 30%) or Active periodontal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Omnia Khaled Tawfik contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo
Amaal Abdalnassar Abdalzeim, 01003752752, amaalabdalnassar@gmail.com
About this study
Official title: Clinical and Radiographic Evaluation of Bone Gain Using Customized 3D Printed Zirconia Barrier Versus Titanium Mesh in Combined Ridge Defects in The Aesthetic Zone: A Randomized Clinical Trial
Evaluation of clinical and radiographical amount of bone gained using customized 3D printed zirconia barrier compared to titanium mesh in combined ridge defect at the esthetic zone.
Read the detailed description
After a tooth is extracted, the alveolar process undergoes an inevitable dimensional change as part of the post extraction remodeling process. The alveolar process is reduced both in the vertical and the horizontal dimension. Therefore, Bone augmentation procedures have been employed to address this issue. A number of bone grafting materials and membranes have been used including resorbable and non-resorbable membranes. It is well-established that non-resorbable membranes produce greater bone augmentation than resorbable ones in terms of their ability to generate new bone. However, their complications make them a less popular option in everyday clinical practice.
Zirconia surfaces show prominent osteo-conductivity, also it has low affinity to bacterial plaque, small amounts of inflammatory infiltrate and good soft-tissue integration. Therefore, this study aims to introduce customized-3D zirconia barriers as a predictable alternative to titanium mesh with horizontal bone gain used as primary outcome.
A randomized clinical trial designed to evaluate the amount of bone gained clinically and radiographically using customized 3D printed zirconia barrier compared to titanium mesh with 26 sites with combined ridge defect total sample size, 13 sites per arm. Once patient preparation is completed and the radiographs are acquired, the patient will be assigned into an arm in the study to allow for barrier manufacturing.
For the zirconia group from the pre-operative CBCT a 3D model of the alveolar jawbone will be created. A 0.4-0.5 mm-thick barrier will then be designed. It will be designed to cover the planned bone graft and extended a few millimeters wider than the graft perimeter. The barrier will be milled and sintered, after milling and finishing, the zirconia meshes will be cleaned, dis-infected and sterilized. At the time of the surgery and after administration of anesthesia, the full thickness flap of the atrophic area will be elevated adjacent to the defect site. Autogenous bone particulate will be harvested. Autogenous bone will be harvested by using an auto-chip maker (ACM) bur, autogenous bone chips that collected with ACM bur will be mixed with a xenograft at 50:50 ratio. A try-in of the barrier will be performed before grafting the area to verify whether its adaptation to the recipient site will be correct. A part of the graft will be placed into the atrophic area and the other part of it was placed into the inner side of the barrier. The barrier will be then placed and according to the clinical situation, two or three fixation screws were tightened at 10 N/cm.
The titanium mesh group, an aluminum foil will be adapted to the defect site and used as a guide for trimming the titanium mesh and ensure its adequate fit. The titanium mesh will be polished to prevent dehiscence or premature exposure. It will then stabilize over the particulate graft by 2 mm titanium mini screws at the labial and palatal sides. Releasing incisions of the flaps will be the next step in the procedure. Then, suturing was performed with single and horizontal mattress sutures.
The patient will be instructed to take antibiotics, antiseptic mouth rinse, anti-inflammatory drugs and instructed to apply an ice pack to the treated area for the first 24 hours and to avoid any brushing or trauma to the surgical site for one week.
After 6 months of a healing period a post-operative CBCT will be performed to assess the effectiveness of the GBR procedure, and then Dental implants will be placed according to the bone dimensions. The osteotomy will be initially done using a 4 mm-diameter trephine bur, instead of the pilot drill to acquire a core biopsy. Sequential drilling will then take place until the correct osteotomy size is created for the implant size
- Conditions
- Bone Loss, Alveolar
- Being tested
- zirconia barrier, titanium mesh
- Keywords
- zirconia membrane, titanium membrane, combined bone defect
- 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.
zirconia barrierProcedure or surgery
Also called zirconia membrane
barrier membrane used for guided bone regeneration and augmentation of ridge defect
titanium meshProcedure or surgery
barrier membrane used for guided bone regeneration
| Study group | Role | What they receive |
|---|---|---|
| zirconia barrier | Active comparator | Zirconia will be used as a barrier material because it has interesting features and, if compared to titanium, it induces a better fibroblast response. It also shows less biofilm adhesion and less inflammatory response. From the pre-operative CBCT a 3D model of the alveolar jaw bone will be created. A 0.4-0.5 mm-thick barrier will then be designed. It will be designed to cover the planned bone graft and extended a few millimeters wider than the graft perimeter. Receives: Procedure: zirconia barrier |
| titanium mesh | Placebo comparator | Titanium mesh in particular, its clinical suitability for GBR procedures is unmatched by other GBR membranes, due to their exceptional volume stability, titanium meshes are indispensable in the management of vertical or large horizontal bone defects. Titanium meshes not only demonstrate high strength and stiffness but also exhibit good plasticity, allowing them to be perfectly adapted to various bone defects through bending and shaping. Due to titanium mesh's stiffness and sharp edges from cutting and bending, mucosal flaps may be adversely stimulated, leading to mucosal rupture and subsequent mesh exposure Receives: Procedure: titanium mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
horizontal bone gain
Horizontal bone gain will be assessed on CBCT after 6 months of bone augmentation
Measured: 6 months
Secondary outcomes (8)
Vertical bone gain
measured on CBCT in a linear dimension as a different in measurement between pre and post operative CBCT.
Measured: 6 months after barrier placement
Quality of bone
The core biopsies will be sectioned and stained with H\&E stain for examination under a light microscope. Bone volume will be measured for each specimen and the mean volume for native bone and newly formed bone will be calculated for statistics
Measured: 6 months after barrier placement
Incidence of membrane exposure
Healing complications including membrane exposure during the period of barrier placement will be recorded and it's evaluated by visual inspection
Measured: up to 4 weeks
Membrane exposure area/percentage
The exposed area will be measured will be assessed by UNC-15 periodontal probe.
Measured: up to 4 weeks
Soft tissue thickness
An endodontic spreader with a rubber stopper will be positioned on the soft tissue to record the thickness of the soft tissue.
Measured: 6 months after barrier placement
Procedural time
Procedural time will be calculated with a stopwatch to measure the time of each procedure and detect differences in the time spend placing and removing the different membranes.
Measured: during the surgery
Patient pain
Readings will be recorded by the patient for the first 12 days after the surgery using the visual analogue scale (VAS) which is a descriptive numerical rating scale of 0 to 10.
0 = No pain 1-3= Mild pain 4-6 = Moderate pain (bearable) 7-10 = Severe pain (unbearable)
Measured: first 12 days after the surgery
Patient satisfaction
Patient will answer questionnaire related to postsurgical and outcome satisfaction (numerical)
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 posted19 Aug 2024
- Study start22 May 2024
- Primary completion22 May 2026 (estimated)
- Study completion22 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, AlveolarStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amaal Abdel Nasser Said Mohamed, Cairo University
- Investigators
- Hani El Nahass, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559605
- Sponsor's protocol ID
- PER 6-3-1.1
- Status last verified
- Aug 2024
- First submitted
- 12 Jul 2024
- Last updated
- 20 Aug 2024
- 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Bone Gain Using Customized 3D Printed Zirconia Barrier Versus Titanium Mesh in Combined Ridge Defects in The Aesthetic Zone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06559605
- Acronym / sponsor ID
- PER 6-3-1.1
- Conditions
- Bone Loss, Alveolar
- Keywords
- zirconia membrane, titanium membrane, combined bone defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 22 May 2026 (estimated)
- Study completion
- 22 Nov 2026 (estimated)
- First posted
- 19 Aug 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.
Evaluation of clinical and radiographical amount of bone gained using customized 3D printed zirconia barrier compared to titanium mesh in combined ridge defect at the esthetic zone.
Detailed description
After a tooth is extracted, the alveolar process undergoes an inevitable dimensional change as part of the post extraction remodeling process. The alveolar process is reduced both in the vertical and the horizontal dimension. Therefore, Bone augmentation procedures have been employed to address this issue. A number of bone grafting materials and membranes have been used including resorbable and non-resorbable membranes. It is well-established that non-resorbable membranes produce greater bone augmentation than resorbable ones in terms of their ability to generate new bone. However, their complications make them a less popular option in everyday clinical practice.
Zirconia surfaces show prominent osteo-conductivity, also it has low affinity to bacterial plaque, small amounts of inflammatory infiltrate and good soft-tissue integration. Therefore, this study aims to introduce customized-3D zirconia barriers as a predictable alternative to titanium mesh with horizontal bone gain used as primary outcome.
A randomized clinical trial designed to evaluate the amount of bone gained clinically and radiographically using customized 3D printed zirconia barrier compared to titanium mesh with 26 sites with combined ridge defect total sample size, 13 sites per arm. Once patient preparation is completed and the radiographs are acquired, the patient will be assigned into an arm in the study to allow for barrier manufacturing.
For the zirconia group from the pre-operative CBCT a 3D model of the alveolar jawbone will be created. A 0.4-0.5 mm-thick barrier will then be designed. It will be designed to cover the planned bone graft and extended a few millimeters wider than the graft perimeter. The barrier will be milled and sintered, after milling and finishing, the zirconia meshes will be cleaned, dis-infected and sterilized. At the time of the surgery and after administration of anesthesia, the full thickness flap of the atrophic area will be elevated adjacent to the defect site. Autogenous bone particulate will be harvested. Autogenous bone will be harvested by using an auto-chip maker (ACM) bur, autogenous bone chips that collected with ACM bur will be mixed with a xenograft at 50:50 ratio. A try-in of the barrier will be performed before grafting the area to verify whether its adaptation to the recipient site will be correct. A part of the graft will be placed into the atrophic area and the other part of it was placed into the inner side of the barrier. The barrier will be then placed and according to the clinical situation, two or three fixation screws were tightened at 10 N/cm.
The titanium mesh group, an aluminum foil will be adapted to the defect site and used as a guide for trimming the titanium mesh and ensure its adequate fit. The titanium mesh will be polished to prevent dehiscence or premature exposure. It will then stabilize over the particulate graft by 2 mm titanium mini screws at the labial and palatal sides. Releasing incisions of the flaps will be the next step in the procedure. Then, suturing was performed with single and horizontal mattress sutures.
The patient will be instructed to take antibiotics, antiseptic mouth rinse, anti-inflammatory drugs and instructed to apply an ice pack to the treated area for the first 24 hours and to avoid any brushing or trauma to the surgical site for one week.
After 6 months of a healing period a post-operative CBCT will be performed to assess the effectiveness of the GBR procedure, and then Dental implants will be placed according to the bone dimensions. The osteotomy will be initially done using a 4 mm-diameter trephine bur, instead of the pilot drill to acquire a core biopsy. Sequential drilling will then take place until the correct osteotomy size is created for the implant size
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zirconia barrier | Active comparator | Procedure: zirconia barrierZirconia will be used as a barrier material because it has interesting features and, if compared to titanium, it induces a better fibroblast response. It also shows less biofilm adhesion and less inflammatory response. From the pre-operative CBCT a 3D model of the alveolar jaw bone will be created. A 0.4-0.5 mm-thick barrier will then be designed. It will be designed to cover the planned bone graft and extended a few millimeters wider than the graft perimeter. |
| titanium mesh | Placebo comparator | Procedure: titanium meshTitanium mesh in particular, its clinical suitability for GBR procedures is unmatched by other GBR membranes, due to their exceptional volume stability, titanium meshes are indispensable in the management of vertical or large horizontal bone defects. Titanium meshes not only demonstrate high strength and stiffness but also exhibit good plasticity, allowing them to be perfectly adapted to various bone defects through bending and shaping. Due to titanium mesh's stiffness and sharp edges from cutting and bending, mucosal flaps may be adversely stimulated, leading to mucosal rupture and subsequent mesh exposure |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 20-70 years.
- Bone width less than 4mm
- Vertical bone height less than 9mm
- Periodontally sound neighboring teeth
- Patients with sound vertical occlusal bite dimension
Key exclusion criteria (5 listed)
- Pathological lesions (abscess-cyst-acute infection) in the defect site
- Systemic diseases that would interfere with bone metabolism
- Uncontrolled diabetic patients
- Ongoing treatment or a history of recent chemotherapy or radiotherapy
- Poor oral hygiene after hygienic phase (Plaque control record over 30%) or Active periodontal disease
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 |
|---|---|---|
| zirconia barrierAlso: zirconia membranebarrier membrane used for guided bone regeneration and augmentation of ridge defect | Procedure or surgery | zirconia barrier |
| titanium meshbarrier membrane used for guided bone regeneration | Procedure or surgery | titanium mesh |
Primary outcome
horizontal bone gain
Time frame: 6 months
Horizontal bone gain will be assessed on CBCT after 6 months of bone augmentation
8 secondary outcomes
Vertical bone gain
Time frame: 6 months after barrier placement
Quality of bone
Time frame: 6 months after barrier placement
Incidence of membrane exposure
Time frame: up to 4 weeks
Membrane exposure area/percentage
Time frame: up to 4 weeks
Soft tissue thickness
Time frame: 6 months after barrier placement
Procedural time
Time frame: during the surgery
Patient pain
Time frame: first 12 days after the surgery
Patient satisfaction
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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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.
Omnia Khaled Tawfik contact
Hani El Nahass study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zirconia barrier and titanium mesh in people with Bone Loss, Alveolar, run by Cairo 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 8 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: looking for participants now, as of the sponsor's last update on 20 Aug 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amaal Abdalnassar abdalzeim (01003752752, amaalabdalnassar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
horizontal bone gain (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 20 Aug 2024.