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A study on the accuracy of dynamic navigation assisted zygomatic implant surgery based on digital personalized minimally invasive registration plate: a single arm, exploratory clinical trial

A study on the accuracy of dynamic navigation assisted zygomatic implant surgery based on digital personalized minimally invasive registration plate: a single arm, exploratory clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089645
Enrollment
Unknown
Registered
2024-09-12
Start date
2024-02-29
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Maxillary edentulism and bone defect

Interventions

Digital personalized minimally invasive registration plate group:The subjects underwent intraoperative registration using a digital personalized minimally invasive registration board, and received dyn

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Male or female patients over 18 years old (including 18 years old); 2) Patients with severe maxillary alveolar ridge atrophy or jawbone defects require zygomatic implant surgery; 3) Two temporary implants are implanted in the patient's anterior tooth area to meet the requirements of the registration plate, or there are existing implants or remaining teeth in the mouth that can firmly fix the registration plate, or the anterior tooth area has enough bone mass to meet the requirements of three or more fixation pins to fix the registration plate; 4) Normal opening degree; 5) Before implementing any research related experimental steps, the experimenter voluntarily signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Oral mucosal lesions (such as lichen planus); 2) Oral space occupying lesions (including cysts, tumors, etc.); 3) Systemic diseases that affect bone healing, wound healing, and dental implant treatment; 4) Contraindications for conventional implant surgery and oral surgery, including bone grafting surgery; 5) History of receiving full dose radiotherapy and local radiotherapy for the head or neck; 6) Patients who are currently or have received medication (such as bisphosphonates) that may affect or promote bone metabolism within the past 3 months; 7) Continuous use of antibiotics or chronic anti-inflammatory therapy (= 3 times per week) within the first 4 weeks of surgery; 8) Smoking tobacco equivalents/chewing more than 10 cigarettes per day; 9) Physical or mental defects affect oral hygiene care; 10) Within the first 30 days prior to the start of surgery (study day 0), the patient participated in clinical trials of other drugs or instruments.

Design outcomes

Primary

MeasureTime frame
Exit deviation of zygomatic implants;

Secondary

MeasureTime frame
Entry deviation of zygomatic implants;Angle deviation of zygomatic implants;Complications related to the new digital personalized minimally invasive registration plate, and its surgical complications, and postoperative complications;

Countries

China

Contacts

Public ContactFeng Wang

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

diana_wangfeng@aliyun.com+86 189 1779 7738

Outcome results

None listed

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