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Tests treatment safety and results for Alveolar Bone Atrophy
Official title Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration
ClinicalTrials.gov ID: NCT06692244
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Patients missing single or multiple teeth with moderate to severe bone defects in the edentulous area requiring complex guided bone regeneration...
- 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...
- The patient and/or his/her guardian agrees to participate in this trial and signs the informed consent form.
You likely can't join 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 treatment clinical trials within 30 days prior to signing the informed consent form.
- History of metal allergies, severe allergy history, or severe immune deficiency.
See the full eligibility criteria
- 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...
- 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...
- The patient and/or his/her guardian agrees to participate in this trial and signs the informed consent form.
- 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 treatment 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.