Ridge Augmentaton and Dental ImplantsNCT06933030
Assessment of Customized 3D Zirconium Versus Titanium Mesh for Anterior Maxillary Ridge Augmentation With Delayed Implant Placement
A study testing titanium mesh with bone graft with delayed implant placement. and zirconium mesh with bone graft with delayed implant placement. in people with Ridge Augmentaton and Dental Implants and Bone Loss, Alveolar, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the present study is to assess the customized 3D zirconium versus titanium mesh for anterior maxillary ridge augmentation with delayed implant placement. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ridge Augmentaton and Dental Implants, Bone Loss, Alveolar
- What is being tested?
- titanium mesh with bone graft with delayed implant placement. and zirconium mesh with bone graft with delayed implant placement.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients from both genders with the age range of 18-60 years with good systemic health, no contraindication for periodontal surgery and able to maintain good oral hygiene.
- Patient with anterior maxillary alveolar ridge deficiency (horizontal, vertical or combined defects) less than 2 mm in width or less than 6 mm in height - measured from the alveolar crest to the basal bone in order to be enrolled in this study. (56)
- Adequate zone of keratinized gingiva at minimum 3mms.
- Patient with sufficient inter-arch space for future dental rehabilitation.
- Subjects who are not on any medication known to interfere with periodontal tissue health or healing within 6 months of the study.
Who cannot join
- History of systemic diseases (i.e. diabetes, autoimmune dysfunction, prolonged cortisone therapy, or chemotherapy) that would contraindicate periodontal surgical treatment or affect bone turn over.
- Patients with deleterious habits like the use of tobacco chewing or smoking ones.
- History of previous periodontal surgical treatment of the involved sites.
- Presence of malocclusion and pathologic movement of teeth in involved sites.
- Patient not willing to give consent for the study and poor plaque control.(57)
- Pregnant or nursing mothers.
- Patients with acute odontogenic infection.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study is to assess the customized 3D zirconium versus titanium mesh for anterior maxillary ridge augmentation with delayed implant placement.
- Being tested
- titanium mesh with bone graft with delayed implant placement., zirconium mesh with bone graft with delayed implant placement.
- Keywords
- ridge augmentation, dental implant, titanium mesh, zirconium mesh
- 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.
titanium mesh with bone graft with delayed implant placement.Device
titanium mesh with bone graft with delayed implant placement.
zirconium mesh with bone graft with delayed implant placement.Device
zirconium mesh with bone graft with delayed implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Group I (controlled group): - | Other | Group I (controlled group):
- Ten sites of anterior maxillary ridge atrophy will be treated by titanium mesh with bone graft with delayed implant placement. Receives: Device: titanium mesh with bone graft with delayed implant placement. |
| Group II (tested group): | Experimental | Group II (tested group):
- Ten sites anterior maxillary ridge atrophy will be treated by zirconium mesh with bone graft with delayed implant placement. Receives: Device: zirconium mesh with bone graft with delayed implant placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation
The patients will be followed up clinically postoperatively every 48-72 hours for the first week then after 2weeks then one month and then after 3 months then after 6 months for preserving: Presence/absence of mesh instability, flap dehiscence, exposed mesh, bone graft loss outside the flap, hematoma or laceration.
Measured: 6 months
Secondary outcomes (2)
radiographic bone volume
A CBCT will be done preoperatively (base line) and after 6 months and finally after 12 months postoperatively to assess dimensions of newly formed bone and its density.
Measured: 6,12 months
histologically
The bone cores, left inside the trephine burs will be carefully rinsed with a cold 5% glucose solution. The specimens will be fixed in 10% formalin solution at pH 7.2 for a week and dehydrated with a graded series of alcohols. After the pre-infiltration treatment the bone cores will then be completely embedded in 100% resin until the specimens became transparent. Finally, the bone cores will be oriented and polymerized.
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 posted17 Apr 2025
- Study start1 Sep 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge Augmentaton and Dental ImplantsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I (controlled group): \- Ten sites of anterior maxillary ridge atrophy will be treated by titanium mesh with bone graft with delayed implant placement. Group II (tested group): \- Ten sites anterior maxillary ridge atrophy will be treated by zirconium mesh with bone graft with delayed implant placement.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Alhashash, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933030
- Sponsor's protocol ID
- OMPDR7-242235
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Customized 3D Zirconium Versus Titanium Mesh for Anterior Maxillary Ridge Augmentation With Delayed Implant Placement
- ClinicalTrials.gov ID
- NCT06933030
- Acronym / sponsor ID
- OMPDR7-242235
- Keywords
- ridge augmentation, dental implant, titanium mesh, zirconium mesh
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 17 Apr 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.
The aim of the present study is to assess the customized 3D zirconium versus titanium mesh for anterior maxillary ridge augmentation with delayed implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group I (controlled group): - Ten sites of anterior maxillary ridge atrophy will be treated by titanium mesh with bone graft with delayed implant placement. Group II (tested group): - Ten sites anterior maxillary ridge atrophy will be treated by zirconium mesh with bone graft with delayed implant placement.
| Arm | Type | Receives |
|---|---|---|
| Group I (controlled group): - | Other | Device: titanium mesh with bone graft with delayed implant placement.Group I (controlled group): - Ten sites of anterior maxillary ridge atrophy will be treated by titanium mesh with bone graft with delayed implant placement. |
| Group II (tested group): | Experimental | Device: zirconium mesh with bone graft with delayed implant placement.Group II (tested group): - Ten sites anterior maxillary ridge atrophy will be treated by zirconium mesh with bone graft with delayed implant placement. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (7 listed)
- History of systemic diseases (i.e. diabetes, autoimmune dysfunction, prolonged cortisone therapy, or chemotherapy) that would contraindicate periodontal surgical treatment or affect bone turn over.
- Patients with deleterious habits like the use of tobacco chewing or smoking ones.
- History of previous periodontal surgical treatment of the involved sites.
- Presence of malocclusion and pathologic movement of teeth in involved sites.
- Patient not willing to give consent for the study and poor plaque control.(57)
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 |
|---|---|---|
| titanium mesh with bone graft with delayed implant placement.titanium mesh with bone graft with delayed implant placement. | Device | Group I (controlled group): - |
| zirconium mesh with bone graft with delayed implant placement.zirconium mesh with bone graft with delayed implant placement. | Device | Group II (tested group): |
Primary outcome
clinical evaluation
Time frame: 6 months
The patients will be followed up clinically postoperatively every 48-72 hours for the first week then after 2weeks then one month and then after 3 months then after 6 months for preserving: Presence/absence of mesh instability, flap dehiscence, exposed mesh, bone graft loss outside the flap, hematoma or laceration.
2 secondary outcomes
radiographic bone volume
Time frame: 6,12 months
histologically
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 17 Apr 2025.
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 titanium mesh with bone graft with delayed implant placement. and zirconium mesh with bone graft with delayed implant placement. in people with Ridge Augmentaton and Dental Implants and Bone Loss, Alveolar, 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 7 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 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?
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?
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?
clinical evaluation (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 17 Apr 2025.