Comparing implant placement methods for patients without teeth
Clinical Accuracy Evaluation of Dynamic Navigation and Static Template for Dental Implant Placement in Completely Edentulous Patients: A Randomized Parallel Controlled Multicenter Clinical Trial
NA · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · NCT06051266
This study tests two different ways to place dental implants in people who have lost all their teeth to see which method works better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Sex | All |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06051266 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the accuracy of two different methods for placing dental implants in patients who are completely edentulous. It is a multicenter, randomized controlled trial that compares dynamic navigation and static template techniques by measuring deviations in implant placement. The study aims to analyze the data using a mixed linear effects model to determine which method provides better precision. Enrollment is competitive among various centers, ensuring a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are completely edentulous or terminally edentulous and have sufficient bone volume for implant placement.
Not a fit: Patients who are not edentulous or do not meet the bone volume requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of dental implant placements, leading to better outcomes for patients without teeth.
How similar studies have performed: Previous studies have shown promising results with similar approaches in implant placement accuracy, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old and above * American society of anesthesiologists (ASA) Levels 1 and 2 * Satisfy any of the following requirements: 1. Edentulous maxillary patients 2. Edentulous mandibular patients 3. Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4) 4. Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4) 5. Full-mouth edentulous patients 6. Full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4) * Implant-supported fixed restorations or implant-supported overdenture restorations * Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software) * Maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase) * Mouth opening of 3 fingers or more * Single-jawed missing patients treated with systemic periodontal therapy Exclusion Criteria: * Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin \>6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.) * ASA grades 3 and 4 * Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth \> 4 mm) and untreated acute and chronic apical periodontitis * Pregnancy or breastfeeding * History of radiotherapy to the head and neck * Heavy smokers (more than 10 cigarettes per day) * Restricted mouth opening (less than three fingers). * Participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).
Where this trial is running
Shanghai
- Shanghai Ninth People's Hospital — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Yiqun Wu — Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study coordinator: Jinyan Chen
- Email: 15652440777@163.com
- Phone: +86 15652440777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Edentulous Jaw