accuracy evaluation of digital navigation implant system

Evaluation of accuracy and patient reported outcome of implant surgery with transcrestal sinus augmentation by a novel digital navigation system: a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005465

Enrollment

Registered

2020-10-12

Start date

2020-10-05

Completion date

Unknown

Last updated

2024-04-02

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

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Individuals who voluntarily sign the informed consent form and meet the selection criteria have been enrolled in this clinical study. Test subjects are randomly ass

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Adults over the age of 19 (2) Partially edentulous patients who need implant placement for maxillary posterior tooth loss (3) Patients who have passed the healing period for more than 3 months after tooth extraction (4) Patients with a vertical bone height of 4-8mm who need a bone graft through a transcrestal approach when placing an implant (5) Patients with sufficient alveolar bone width and who do not need horizontal bone graft (6) Patients who have no systemic implant placement problems (7) Patients with no lesions such as cysts in the maxillary sinus

Exclusion criteria

Exclusion criteria: (1) Minors under the age of 19 (2) Uncontrolled metabolic systemic disease (diabetes, etc.) (3) Pregnant or lactating women (4) Patients with a history of radiation irradiation treatment and chemotherapy in the head and neck area (5) Patients with a history of taking Bisphosphonate drugs within 4 months (6) Patients suffering from other systemic or oral diseases that are contraindicated in the progress of implant treatment (7) Smokers with more than one pack (20) per day

Design outcomes

Primary

Measure	Time frame
Placement position accuracy;Vertical variation: vertical height difference of the fixed platform (mm);Angle variation: difference in angles of the major axis of the fixture (degrees);Platform's horizontal shift: The fixture platform's horizontal position difference (mm);horizontal shift of apex: difference in horizontal position of fixture apex (mm)	—

Secondary

Measure	Time frame
Comparison of soft tissue healing patterns;total treatment time;Patient related outcome measurement;Clinician related outcome measurement	—

Countries

Korea, Republic of

Contacts

Public Contactjooyeon Lee

Yonsei University Health System, Dental Hospital

dlwndus34@naver.com+82-2-2228-8825

Outcome results