Using personalized titanium mesh for bone regeneration in dental patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: hsujiayun@outlook.com
• Phone: +86 135 3354 6195

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.