Using personalized titanium mesh for bone regeneration in dental patients

Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration: a Randomized, Single-blind, Positive-controlled Prospective Study

This study tests whether using custom-made titanium mesh can help dental patients with serious bone loss heal better than standard titanium mesh.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Hospital of Stomatology, Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06692244 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of personalized titanium mesh compared to traditional titanium mesh in guided bone regeneration for patients with significant alveolar bone defects. It is a single-blind, randomized, positive-controlled trial that will monitor participants for two years post-surgery, assessing both short-term and long-term outcomes, including complications. The goal is to determine the advantages of additive-manufactured personalized mesh in improving bone regeneration outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients missing single or multiple teeth with moderate to severe bone defects requiring guided bone regeneration.

Not a fit: Patients with mild bone defects or those who are edentulous may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved bone regeneration and better dental implant outcomes for patients with severe bone loss.

How similar studies have performed: While similar approaches have been explored, the use of personalized titanium mesh in this specific context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. 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.）
2. 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.
3. The patient and/or his/her guardian agrees to participate in this trial and signs the informed consent form.

Exclusion Criteria:

1. Patients with edentulism.
2. Patients with mild bone defects (residual alveolar ridge width greater than 3 mm).
3. Presence of acute or chronic infection in the surgical area.
4. Presence of acute or chronic infection in the teeth adjacent to the edentulous area.
5. Participation in similar trials or other interventional clinical trials within 30 days prior to signing the informed consent form.
6. History of metal allergies, severe allergy history, or severe immune deficiency.
7. 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).
8. Long-term use of steroid medications.
9. History of drug abuse or alcoholism.
10. Pregnant or breastfeeding women.
11. Poor compliance.
12. Other conditions deemed unsuitable for participation by the investigator.

Where this trial is running

Guangzhou, Guangdong

• Hospital of Stomatology, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Jinming Wang — Hospital of Stomatology, Sun Yat-Sen University
• Study coordinator: Jiayun Xu

Conditions Alveolar Bone Atrophy; Guided Bone Regeneration