Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration
Recruiting
N/AInterventional Study
Alveolar Bone AtrophyGuided Bone Regeneration
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
142 (estimated)
Sponsor
Hospital of Stomatology, Sun Yat-Sen University · Other
Who this trial is looking for
This trial is looking for patients who are missing one or more teeth and have moderate to severe bone loss in the area where the teeth are missing. Participants will have surgery using a special titanium mesh and will be followed up for two years with free check-ups.
I have moderate to severe bone loss in the area where my teeth are missing.
The edge of my toothless area is close to existing bone.
I agree to participate in this trial and sign the consent form.
You may not be able to join if
I am completely toothless.
I have mild bone defects.
I have an active infection in the surgery area.
I have an active infection in my nearby teeth.
I participated in a similar trial in the last month.
I have a history of severe allergies or immune deficiency.
I have uncontrolled metabolic diseases or severe organ dysfunction.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
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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 re…
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.
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