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Clinical Trials in China / NCT06692244
Recruiting Not applicable

Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration

NCT06692244 · tracked via the Priya Life Science China tracker
Sponsor
Hospital of Stomatology, Sun Yat-Sen University
Phase
Not applicable
Started
2024-11-30
Last updated
2025-03-11

Condition(s) studied

Alveolar Bone AtrophyGuided Bone Regeneration

Investigational drug(s) / intervention(s)

Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium MeshGuided Bone Regeneration Surgery Using Prefabricated Titanium Mesh

Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh: 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 Mesh: 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 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital of Stomatology, Sun Yat-Sen University Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06692244 on ClinicalTrials.gov ↗ ← All trials in China