Actively Recruiting
A Clinical Exploratory Study of Root Analogy Implant for Immediate Dental Implantation
Led by The Dental Hospital of Zhejiang University School of Medicine · Updated on 2024-06-10
10
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the use of 3D printed personalized root-shaped implants for immediate dental implantation. Immediate implantation is becoming more popular because it requires fewer surgeries, shorter waiting times, and less impact on appearance. The study aims to address complications caused by mismatches between traditional implants and extraction sockets using these personalized implants, which have shown good bone bonding in animal studies. This study involves a single group receiving the 3D printed root analogy implant made from pure titanium powder using laser melting printing technology. The implant system is designed to fit the bone precisely, potentially reducing surgery time and frequency while restoring chewing function. The implant base and accessories are made by conventional methods from titanium rods. Participants will have their alveolar ridge height and width, implant mobility, gingival condition, exploration depth, bleeding, implant looseness, chewing function recovery, and aesthetic satisfaction monitored over 48 weeks. Assessments occur at day 0, 12 weeks, 24 weeks, and 48 weeks. The study includes detailed follow-ups to evaluate implant performance and patient outcomes throughout the year-long study period.
CONDITIONS
Brief Title
The Application of Root Analogy Implant in Immediate Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 60 years, any gender
- Good oral hygiene
- No systemic diseases
- Presence of irreparable residual roots with no obvious apical periodontitis and tooth looseness not greater than degree II
- Tooth position includes four quadrant anterior teeth and premolars
- Root length greater than 10 mm and no significant bone resorption at alveolar crest
- No significant displacement of adjacent teeth and no significant elongation of opposing teeth
- Bone density of target implant area is Class II or Class III
- Lateral bone wall of lips (cheeks), palate (tongue) intact and larger than 1 mm
- Ability to understand study purpose, willing to cooperate with surgery and follow-up, and sign informed consent form
You will not qualify if you...
- Moderate to severe periodontitis
- Missing proximal and distal adjacent teeth in target residual root
- Residual roots with root adhesion
- Bone density of target implant area is Class I or IV
- Active acute infectious disease or metabolic bone disease
- History of diabetes with poor blood glucose control (fasting glucose ≥ 8.8 mmol/L)
- Liver or kidney dysfunction (AST, ALT ≥ 1.5 times upper limit; creatinine ≥ 1.5 times upper limit)
- History of osteoporosis
- History of malignant tumors or serious illnesses unsuitable for surgery
- Mental disorders with lack of autonomous behavior
- Pregnant, lactating, menstruating, or planning pregnancy within six months
- Imaging artifacts in surgical area
- Medication affecting bone metabolism within past three months (e.g., bisphosphonates)
- Poor compliance or other factors making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants receive a 3D printed personalized root analogy implant for immediate dental implantation.
1 visit (in-person)
Duration - Up to 48 weeks
Participants attend follow-up visits to assess alveolar ridge height, implant mobility, gingival condition, exploration depth, implant looseness, chewing function recovery, and aesthetic satisfaction.
Visits on Day 0, 12 weeks, 24 weeks, and 48 weeks
Trial Site Locations
Total: 1 location
1
The Affiliated Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
Y
Yixu Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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