PrefabricatedNCT07163351
Prefabricated CAD CAM Allogeneic Ring Blocks in the Anterior Maxilla With Immediate Implantation
A study testing CAD/CAM allogenic bone block in people with Prefabricated and CAD, run by Tanta University at 1 site in Egypt.
Trial summary
Clinical and radiographic evaluation of a new modification of ring technique using omputeraided design/computer-aided manufacturing (CAD/CAM) milling of allogeneic bone block for anterior maxilla ridge augmentation with immediate implantation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prefabricated, CAD, CAM
- What is being tested?
- CAD/CAM allogenic bone block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years.
- Both sexes.
- Patients presenting with anterior maxillary alveolar bone defects resulting from previous implant failure.
- Systemically healthy individuals, classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Participants were either non-smokers or light smokers consuming fewer than 10 cigarettes per day.
Who cannot join
- Uncontrolled systemic conditions such as diabetes mellitus or osteoporosis.
- Pregnant or breastfeeding at the time of recruitment.
- Individuals with a history of head or neck radiation therapy.
- Cases in which insufficient bone volume for implant placement persisted following augmentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prefabricated CAD CAM Allogeneic Ring Blocks in the Anterior Maxilla With Immediate Implantation a Prospective Single-Arm Clinical Study
Clinical and radiographic evaluation of a new modification of ring technique using omputeraided design/computer-aided manufacturing (CAD/CAM) milling of allogeneic bone block for anterior maxilla ridge augmentation with immediate implantation
Read the detailed description
Dental implant failure remains a clinically significant challenge, with early failures typically attributed to insufficient osseointegration, surgical trauma, bacterial contamination, or micromotion during healing. In contrast, late failures are often associated with occlusal overload, peri-implantitis, or implant mispositioning.
These challenges have driven the adoption of allogeneic bone blocks, particularly those fabricated using computeraided design/computer-aided manufacturing (CAD/CAM) technology, which offer precise anatomical adaptation, reduced surgical time, and minimized complications compared to manual grafting techniques
- Conditions
- Prefabricated, CAD, CAM, Allogeneic Ring Blocks, Anterior Maxilla, Immediate Implantation
- Being tested
- CAD/CAM allogenic bone block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM allogenic bone blockOther
CAD/CAM allogenic bone block augmentation with immediate non-functional implant loading
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients presented with anterior maxillary alveolar bone defects resulting from previous implant failure Receives: Other: CAD/CAM allogenic bone block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical/Horizonal Bone Gain
Vertical/Horizonal Bone Gain was measured via cone beam computed tomography superimposition at 18 months
Measured: 18 months post-procedure
Secondary outcomes (3)
Implant Survival Rate
Implant survival rate, defined as the absence of clinical mobility, peri-implant infection, persistent pain, or radiographic evidence of peri-implant radiolucency or bone loss beyond expected physiological remodelling. Implant stability was assessed clinically using percussion and mobility tests, and radiographically using periapical radiographs and/or cone-beam computed tomography at designated follow-up intervals. Survival was evaluated at 6, 12, and 18 months postoperatively
Measured: 18 months post-procedure
Assessment of aesthetic outcome
Assessment of aesthetic outcome were assessed using the Pink Esthetic Score (PES), a validated clinical index that evaluates seven soft tissue parameters around the implant site: mesial and distal papillae, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color, and texture. PES was evaluated at 12 and 18 months by two calibrated examiners blinded to the treatment allocation.
Measured: 18 months post-procedure
Patient Satisfaction
Patient-reported satisfaction with the aesthetic and functional outcomes was measured using a 10-point Visual Analog Scale (VAS). Patients were asked to rate their satisfaction with the final restoration, including perceived appearance, comfort, and chewing efficiency at 12 and 18 months postoperatively. Mean VAS scores were analyzed and compared over time.
Measured: 18 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Jan 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrefabricatedStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Omar Elboraey Elbal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163351
- Sponsor's protocol ID
- AUAREC20240001-7
- Status last verified
- Aug 2025
- First submitted
- 31 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prefabricated CAD CAM Allogeneic Ring Blocks in the Anterior Maxilla With Immediate Implantation a Prospective Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07163351
- Acronym / sponsor ID
- AUAREC20240001-7
- Conditions
- Prefabricated, CAD, CAM, Allogeneic Ring Blocks, Anterior Maxilla, Immediate Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 9 Sep 2025 (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.
Clinical and radiographic evaluation of a new modification of ring technique using omputeraided design/computer-aided manufacturing (CAD/CAM) milling of allogeneic bone block for anterior maxilla ridge augmentation with immediate implantation
Detailed description
Dental implant failure remains a clinically significant challenge, with early failures typically attributed to insufficient osseointegration, surgical trauma, bacterial contamination, or micromotion during healing. In contrast, late failures are often associated with occlusal overload, peri-implantitis, or implant mispositioning.
These challenges have driven the adoption of allogeneic bone blocks, particularly those fabricated using computeraided design/computer-aided manufacturing (CAD/CAM) technology, which offer precise anatomical adaptation, reduced surgical time, and minimized complications compared to manual grafting techniques
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: CAD/CAM allogenic bone blockPatients presented with anterior maxillary alveolar bone defects resulting from previous implant failure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 65 years.
- Both sexes.
- Patients presenting with anterior maxillary alveolar bone defects resulting from previous implant failure.
- Systemically healthy individuals, classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Participants were either non-smokers or light smokers consuming fewer than 10 cigarettes per day.
Key exclusion criteria (4 listed)
- Uncontrolled systemic conditions such as diabetes mellitus or osteoporosis.
- Pregnant or breastfeeding at the time of recruitment.
- Individuals with a history of head or neck radiation therapy.
- Cases in which insufficient bone volume for implant placement persisted following augmentation.
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 |
|---|---|---|
| CAD/CAM allogenic bone blockCAD/CAM allogenic bone block augmentation with immediate non-functional implant loading | Other | Study group |
Primary outcome
Vertical/Horizonal Bone Gain
Time frame: 18 months post-procedure
Vertical/Horizonal Bone Gain was measured via cone beam computed tomography superimposition at 18 months
3 secondary outcomes
Implant Survival Rate
Time frame: 18 months post-procedure
Assessment of aesthetic outcome
Time frame: 18 months post-procedure
Patient Satisfaction
Time frame: 18 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Prefabricated
Not yet recruiting
Clinical Evaluation of Two Post Systems for Single Crown Restoration of Anterior Teeth
Cairo University, Nonvital Tooth
Active, not recruiting
Gingival Health After Zirconia Versus Stainless Steel Crowns in Children
Gingival Disease
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
Not yet recruiting
Foot Orthoses in the Treatment of Painful Hallux Valgus
Hallux Valgus
Not yet recruiting
Assessment of Clinical Success of Custom-Made Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars
Primary Molar Tooth, Pulpotomies Primary Teeth
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 study testing CAD/CAM allogenic bone block in people with Prefabricated and CAD, run by Tanta 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 5 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: finished, as of the sponsor's last update on 9 Sep 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vertical/Horizonal Bone Gain (time frame: 18 months post-procedure). 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 9 Sep 2025.