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

NCT06692244 | Recruiting

• 1 other identifier: GHKQ-202408-L3
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Atrophy; Guided Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after surgery

Secondary Outcomes (1)

• Incidence of titanium mesh exposure

  14 days, 1 month, 6 months, 1 year, and 2 years after surgery

Study Arms (2)

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.

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

Prefabricated Titanium Mesh

ACTIVE COMPARATOR

Use prefabricated titanium mesh for guided bone regeneration.

Procedure: Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh

Interventions

Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh PROCEDURE

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.

Personalized Titanium Mesh

Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh PROCEDURE

In bone grafting surgery, prefabricated titanium mesh is used to fix the bone substitutes, and fixation screws are used to secure the titanium mesh.

Prefabricated Titanium Mesh

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hospital of Stomatology, Sun Yat-Sen University: lead
• Southern Medical University, China: collaborator
• Meizhou People's Hospital: collaborator
• Shenzhen Stomatology Hospital: collaborator
• Guangzhou Medical University: collaborator

Study Sites (1)

Hospital of Stomatology, Sun Yat-Sen University

Guangzhou, Guangdong, 510030, China

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jinming Wang

  Hospital of Stomatology, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayun Xu

CONTACT

+86 135 3354 6195; hsujiayun@outlook.com

Jinming Wang

CONTACT

+86 135 3545 8675; wjinm@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 11, 2025

Record last verified: 2025-01

Locations

CN (1)