Tooth LossNCT06077513
Ti-Mesh Frame Comparison for Alveolar Bone Augmentation
A study testing CAD-CAM designed and preprinted Ti-Mesh frame and Conventional chairside fabrication of Ti-Mesh frame in people with Tooth Loss, run by Boston University at 1 site in United States.
Trial summary
This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tooth Loss
- What is being tested?
- CAD-CAM designed and preprinted Ti-Mesh frame and Conventional chairside fabrication of Ti-Mesh frame
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2024to Dec 2027
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Partially edentulous
- Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement
Who cannot join
- Poor oral hygiene indices for microbial plaque (PI) and gingival inflammation (GI)
- Patients who have been on Chemotherapy or Radiation therapy within last 5 years.
- Patients under active treatment with following medications: Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements.
- Subjects under the direct supervision of the PI
- Smoking more than 10 cigarettes per day
- Uncontrolled diabetes or other metabolic disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
BU Goldman School of Dental Medicine
Boston, Massachusetts, 02118
About this study
Official title: Human Alveolar Bone Augmentation: Comparison 3-D CAD-CAM Ti-mesh Frame With a Conventional Ti-Mesh Frame Fabricated at Time of Surgery
This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries.
The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time.
Read more
A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives:
- Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
- Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period.
- Conditions
- Tooth Loss
- Being tested
- CAD-CAM designed and preprinted Ti-Mesh frame, Conventional chairside fabrication of Ti-Mesh frame
- Keywords
- Conventional Ti-Mesh frame, CAD-CAM printed ti-Mesh frame, Dental implants, 3-D Alveolar Bone Augmentation, Surgery time, Post op mesh exposure, Post op bone added
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD-CAM designed and preprinted Ti-Mesh frameProcedure or surgery
CAD-CAM technology which is the process of designing and manufacturing a custom-made dental device, or a patient-specific dental device from an industrialized product, with the aid of a computer.will be used to plan and preprint a 3-D Ti-Mesh frame prior to the surgery.
Conventional chairside fabrication of Ti-Mesh frameProcedure or surgery
A three-dimensional frame or cage of Ti-Mesh or Ti-reinforced d-polytetrafluoroethylene (PTFE) will be fashioned during the surgery to contain, shape and stabilize the bone graft materials (the internal scaffold). This 3-D frame will be custom fabricated from a perforated Ti Mesh sheet material at the time of surgery which takes considerable time and skill.
| Study group | Role | What they receive |
|---|---|---|
| CAD-CAM Ti-Mesh frame | Experimental | Participants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery. Receives: Procedure: CAD-CAM designed and preprinted Ti-Mesh frame |
| Conventional Ti-Mesh frame | Active comparator | Participants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during surgery. Receives: Procedure: Conventional chairside fabrication of Ti-Mesh frame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone contour accuracy
Bone contour accuracy will be derived by merger of the post op Cone beam computed tomography (CBCT) DICOM file with the CBCT-1/CEREC-1/Virtual Implant file produced at the planning stage. Accuracy of fit will be calculated for volume and linear measures (4 sides of each implant-MDBL) horizontal and vertical from the implant restorative platform.
Measured: 5 months post op
Total surgical time
Total surgical time is defined as from incision time to completion of sutures and will be measured in minutes.
Measured: 2 hours
Surgical exposure time for recipient site
Surgical exposure time will be measured for recipient site in minutes
Measured: 5 minutes
Secondary outcomes (4)
Ti-Mesh exposure incidence
Number of exposures
Measured: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Ti-Mesh exposure size
Ti-Mesh exposure size will be measured in millimeters
Measured: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Ti-Mesh exposure location
Ti-Mesh exposure location will be documented within mucosa, gingiva, or at the incision line
Measured: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Percentage of Vital bone
Percentage of vital bone will be measured in histologic sections of bone core taken at time of implant surgery.
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 posted11 Oct 2023
- Study start25 Jan 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge Dibart, DMD, Principal investigator, BU Goldman School of Dental Medicine, Oral Biology/PeriodonticsAlbert M Price, DMD, Study director, BU Goldman School of Dental Medicine, Oral Biology/Periodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077513
- Sponsor's protocol ID
- H-43856
- Other IDs
- AP 37
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Alveolar Bone Augmentation: Comparison 3-D CAD-CAM Ti-mesh Frame With a Conventional Ti-Mesh Frame Fabricated at Time of Surgery
- ClinicalTrials.gov ID
- NCT06077513
- Acronym / sponsor ID
- H-43856
- Conditions
- Tooth Loss
- Keywords
- Conventional Ti-Mesh frame, CAD-CAM printed ti-Mesh frame, Dental implants, 3-D Alveolar Bone Augmentation, Surgery time, Post op mesh exposure, Post op bone added
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Oct 2023 (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 research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries.
The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time.
A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives:
- Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
- Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD-CAM Ti-Mesh frame | Experimental | Procedure: CAD-CAM designed and preprinted Ti-Mesh frameParticipants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery. |
| Conventional Ti-Mesh frame | Active comparator | Procedure: Conventional chairside fabrication of Ti-Mesh frameParticipants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Partially edentulous
- Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement
Key exclusion criteria (6 listed)
- Poor oral hygiene indices for microbial plaque (PI) and gingival inflammation (GI)
- Patients who have been on Chemotherapy or Radiation therapy within last 5 years.
- Patients under active treatment with following medications: Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements.
- Subjects under the direct supervision of the PI
- Smoking more than 10 cigarettes per day
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 designed and preprinted Ti-Mesh frameCAD-CAM technology which is the process of designing and manufacturing a custom-made dental device, or a patient-specific dental device from an industrialized product, with the aid of a computer.will be used to plan and preprint a 3-D Ti-Mesh frame prior to the surgery. | Procedure or surgery | CAD-CAM Ti-Mesh frame |
| Conventional chairside fabrication of Ti-Mesh frameA three-dimensional frame or cage of Ti-Mesh or Ti-reinforced d-polytetrafluoroethylene (PTFE) will be fashioned during the surgery to contain, shape and stabilize the bone graft materials (the internal scaffold). This 3-D frame will be custom fabricated from a perforated Ti Mesh sheet material at the time of surgery which takes considerable time and skill. | Procedure or surgery | Conventional Ti-Mesh frame |
Primary outcome
Bone contour accuracy
Time frame: 5 months post op
Bone contour accuracy will be derived by merger of the post op Cone beam computed tomography (CBCT) DICOM file with the CBCT-1/CEREC-1/Virtual Implant file produced at the planning stage. Accuracy of fit will be calculated for volume and linear measures (4 sides of each implant-MDBL) horizontal and vertical from the implant restorative platform.
Total surgical time
Time frame: 2 hours
Total surgical time is defined as from incision time to completion of sutures and will be measured in minutes.
Surgical exposure time for recipient site
Time frame: 5 minutes
Surgical exposure time will be measured for recipient site in minutes
4 secondary outcomes
Ti-Mesh exposure incidence
Time frame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Ti-Mesh exposure size
Time frame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Ti-Mesh exposure location
Time frame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Percentage of Vital bone
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 1 Oct 2026.
- 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.
Serge Dibart, DMD principal investigator
BU Goldman School of Dental Medicine, Oral Biology/Periodontics
Albert M Price, DMD study director
BU Goldman School of Dental Medicine, Oral Biology/Periodontics
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 designed and preprinted Ti-Mesh frame and Conventional chairside fabrication of Ti-Mesh frame in people with Tooth Loss, run by Boston University at 1 site in United States.
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 2 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 1 Oct 2026. 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 United States. 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?
Bone contour accuracy (time frame: 5 months post op). The study lists 3 primary outcomes in all. 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 1 Oct 2026.