Alveolar Bone AtrophyNCT06692244
Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration
A study testing Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh and Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh in people with Alveolar Bone Atrophy and Guided Bone Regeneration, run by Hospital of Stomatology, Sun Yat-Sen University at 1 site in China.
Trial summary
This goal of this single-blind, simple randomized, positive-controlled prospective study is to evaluate the effects of additive-manufactured personalized titanium mesh and traditional titanium mesh in guided bone regeneration for large alveolar bone defects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alveolar Bone Atrophy, Guided Bone Regeneration
- What is being tested?
- Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh and Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2024to Dec 2028
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients missing single or multiple teeth with moderate to severe bone defects in the edentulous area requiring complex guided bone regeneration. （Moderate bone defects: bone loss with residual alveolar ridge width between 1 mm and 3 mm; severe bone defects: bone loss with residual alveolar ridge width ≤ 1 mm.）
- The edge of the edentulous area within 1 mm is alveolar bone, with no adjacent tooth roots or nerve canals, ensuring complete retention of the personalized titanium mesh edge. The apical edge of the edentulous area within 2 mm is alveolar bone, with no nerve canals, ensuring that retention screws for the personalized titanium mesh can be designed in this area.
- The patient and/or his/her guardian agrees to participate in this trial and signs the informed consent form.
Who cannot join
- Patients with edentulism.
- Patients with mild bone defects (residual alveolar ridge width greater than 3 mm).
- Presence of acute or chronic infection in the surgical area.
- Presence of acute or chronic infection in the teeth adjacent to the edentulous area.
- Participation in similar trials or other interventional clinical trials within 30 days prior to signing the informed consent form.
- History of metal allergies, severe allergy history, or severe immune deficiency.
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- Uncontrolled metabolic diseases, such as Type 1 diabetes or Type 2 diabetes (HbA1c ≥ 7% or fasting blood glucose ≥ 7 mmol/L despite medication control), severe liver or kidney dysfunction (ALT, AST > 2 times the upper limit of normal, serum creatinine above the upper limit of normal).
- Long-term use of steroid medications.
- History of drug abuse or alcoholism.
- Pregnant or breastfeeding women.
- Poor compliance.
- Other conditions deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hospital of Stomatology, Sun Yat-Sen University
Guangzhou, Guangdong, 510030
Xu, +86 135 3354 6195, hsujiayun@outlook.com
About this study
Official title: Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration: a Randomized, Single-blind, Positive-controlled Prospective Study
This goal of this single-blind, simple randomized, positive-controlled prospective study is to evaluate the effects of additive-manufactured personalized titanium mesh and traditional titanium mesh in guided bone regeneration for large alveolar bone defects. The study will assess the short-term and long-term efficacy, safety, and incidence of complications of the additive-manufactured personalized titanium mesh, along with an analysis of risk factors. Participants will be followed up for two years after surgery with free-of-charge clinical and radiographic examinations.
- Conditions
- Alveolar Bone Atrophy, Guided Bone Regeneration
- Being tested
- Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh, Guided Bone Regeneration Surgery Using Prefabricated Titanium 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.
Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium MeshProcedure or surgery
Preoperative CBCT datas of participants are obtained to design and manufacture personalized titanium meshes.Use additive-manufactured personalized titanium meshes for guided bone regeneration.In the bone grafting surgery, the additive-manufactured personalized titanium mesh is used to secure the bone substitutes, with fixation screws used to secure the titanium mesh.
Guided Bone Regeneration Surgery Using Prefabricated Titanium MeshProcedure or surgery
In bone grafting surgery, prefabricated titanium mesh is used to fix the bone substitutes, and fixation screws are used to secure the titanium mesh.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Titanium Mesh | Experimental | Preoperative CBCT datas of participants are obtained to design and manufacture personalized titanium meshes.Use additive-manufactured personalized titanium meshes for guided bone regeneration. Receives: Procedure: Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh |
| Prefabricated Titanium Mesh | Active comparator | Use prefabricated titanium mesh for guided bone regeneration. Receives: Procedure: Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteogenesis efficiency
Based on the oral CBCT imaging data, bone volume is reconstructed for preoperative, the day of surgery, and six months after surgery. Bone volume changes are assessed by using mimics as the bone resorption rate. The bone formation effectiveness is evaluated based on the bone resorption rate.
Measured: 6 months after surgery
Secondary outcomes (1)
Incidence of titanium mesh exposure
Record and observe the exposure of the titanium mesh during the healing process.
Measured: 14 days, 1 month, 6 months, 1 year, and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start30 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone AtrophyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital of Stomatology, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Medical University, China, Meizhou People's Hospital, Shenzhen Stomatology Hospital, Guangzhou Medical University
- Responsible party
- Principal investigator, Wang Jinming, Hospital of Stomatology, Sun Yat-Sen University
- Investigators
- Jinming Wang, Principal investigator, Hospital of Stomatology, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692244
- Sponsor's protocol ID
- GHKQ-202408-L3
- Status last verified
- Jan 2025
- First submitted
- 14 Nov 2024
- Last updated
- 11 Mar 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration: a Randomized, Single-blind, Positive-controlled Prospective Study
- ClinicalTrials.gov ID
- NCT06692244
- Acronym / sponsor ID
- GHKQ-202408-L3
- Conditions
- Alveolar Bone Atrophy, Guided Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Hospital of Stomatology, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Southern Medical University, China, Meizhou People's Hospital, Shenzhen Stomatology Hospital, Guangzhou Medical University
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Nov 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.
This goal of this single-blind, simple randomized, positive-controlled prospective study is to evaluate the effects of additive-manufactured personalized titanium mesh and traditional titanium mesh in guided bone regeneration for large alveolar bone defects. The study will assess the short-term and long-term efficacy, safety, and incidence of complications of the additive-manufactured personalized titanium mesh, along with an analysis of risk factors. Participants will be followed up for two years after surgery with free-of-charge clinical and radiographic examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Titanium Mesh | Experimental | Procedure: Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium MeshPreoperative CBCT datas of participants are obtained to design and manufacture personalized titanium meshes.Use additive-manufactured personalized titanium meshes for guided bone regeneration. |
| Prefabricated Titanium Mesh | Active comparator | Procedure: Guided Bone Regeneration Surgery Using Prefabricated Titanium MeshUse prefabricated titanium mesh for guided bone regeneration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients missing single or multiple teeth with moderate to severe bone defects in the edentulous area requiring complex guided bone regeneration. （Moderate bone defects: bone loss with residual alveolar ridge width between 1 mm and 3 mm; severe bone defects: bone loss with residual alveolar ridge width ≤ 1 mm.）
- The edge of the edentulous area within 1 mm is alveolar bone, with no adjacent tooth roots or nerve canals, ensuring complete retention of the personalized titanium mesh edge. The apical edge of the edentulous area within 2 mm is alveolar bone, with no nerve canals, ensuring that retention screws for the personalized titanium mesh can be designed in this area.
- The patient and/or his/her guardian agrees to participate in this trial and signs the informed consent form.
Key exclusion criteria (12 listed)
- Patients with edentulism.
- Patients with mild bone defects (residual alveolar ridge width greater than 3 mm).
- Presence of acute or chronic infection in the surgical area.
- Presence of acute or chronic infection in the teeth adjacent to the edentulous area.
- Participation in similar trials or other interventional clinical trials within 30 days prior to signing the informed consent form.
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 |
|---|---|---|
| Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium MeshPreoperative CBCT datas of participants are obtained to design and manufacture personalized titanium meshes.Use additive-manufactured personalized titanium meshes for guided bone regeneration.In the bone grafting surgery, the additive-manufactured personalized titanium mesh is used to secure the bone substitutes, with fixation screws used to secure the titanium mesh. | Procedure or surgery | Personalized Titanium Mesh |
| Guided Bone Regeneration Surgery Using Prefabricated Titanium MeshIn bone grafting surgery, prefabricated titanium mesh is used to fix the bone substitutes, and fixation screws are used to secure the titanium mesh. | Procedure or surgery | Prefabricated Titanium Mesh |
Primary outcome
Osteogenesis efficiency
Time frame: 6 months after surgery
Based on the oral CBCT imaging data, bone volume is reconstructed for preoperative, the day of surgery, and six months after surgery. Bone volume changes are assessed by using mimics as the bone resorption rate. The bone formation effectiveness is evaluated based on the bone resorption rate.
1 secondary outcome
Incidence of titanium mesh exposure
Time frame: 14 days, 1 month, 6 months, 1 year, and 2 years after surgery
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 11 Mar 2025.
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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.
Jinming Wang principal investigator
Hospital of Stomatology, Sun Yat-Sen 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 Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh and Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh in people with Alveolar Bone Atrophy and Guided Bone Regeneration, run by Hospital of Stomatology, Sun Yat-Sen University at 1 site in China.
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 12 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 11 Mar 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 China. 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?
Contact Jiayun Xu (+86 135 3354 6195, hsujiayun@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteogenesis efficiency (time frame: 6 months after surgery). 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 11 Mar 2025.