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A prospective randomized controlled multicenter clinical trial to compare the accuracy of static guide plate and dynamic navigation system in edentulous patients

A prospective randomized controlled multicenter clinical trial to compare the accuracy of static guide plate and dynamic navigation system in edentulous patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026731
Enrollment
Unknown
Registered
2019-10-20
Start date
2020-04-01
Completion date
Unknown
Last updated
2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dental implant placement

Interventions

dynamic guided group:dynamic guided implant placement
static guided group:static guided implant placement

Sponsors

The Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) male or female patients aged 18 to 65 years (including 18 and 65 years old) who received implant repair; 2) patients with severe periodontitis of half / whole teeth need to be extracted; 3) the loss time of half / full dentition is more than 3 months, and the remaining bone mass can provide the initial stability of the implant; 4) the alveolar ridge has enough vertical height, enough horizontal bone width, and can be used in the whole process of guide plate guided implant surgery; 5) prior to the implementation of any study related test steps, the subjects voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) oral mucosal lesions (such as lichen planus); 2) the oral cavity has space occupying lesions (including cyst, tumor, etc.); 3) systemic diseases that affect bone healing, wound healing and dental implant therapy (such as uncontrolled and stable diabetes, the fasting blood glucose was still >= 8.8 mmol); 4) uncontrolled and stable severe hypertension; 5) contraindications of conventional implant and oral surgery, including bone grafting; 6) heart disease (grade II or above heart function disease); 7) patients with liver and kidney dysfunction or abnormality; 8) obesity patients, BMI > 28KG / M; 9) received full dose radiotherapy, local radiotherapy history of head or neck; 10) patients requiring long-term high-dose steroid treatment; 11) patients have been treated with drugs (such as bisphosphate) that may affect or promote bone metabolism in the past 3 months; 12) in the first 4 weeks of operation, antibiotic treatment or chronic anti-inflammatory treatment (at least 3 times a week) was used continuously; 13) alcoholism or long-term drug abuse; 14) patients with incomplete immune function; 15) smoking tobacco equivalent / chewing tobacco more than 10 cigarettes per day; 16) physical or mental defects affect oral health care; 17) patients who are allergic to the product; 18) pregnant or lactating female patients; 19) patients with poor compliance who could not participate in the trial, according to the researchers; 20) within the first 30 days of the operation (day 0), the patient participated in clinical trials of other drugs or devices.

Design outcomes

Primary

MeasureTime frame
entry deviation of implant;apical deviation of implant;angle deviation of implant;

Secondary

MeasureTime frame
operation time;Patient satisfaction;implant survival rate;

Countries

China

Contacts

Public ContactWu Yiqun

The Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University

yiqunwu@outlook.com+86 13916892306

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026