Accuracy and Primary Stability in Immediate Implant Placement: Dynamic Navigation Versus Freehand

NCT04999956 | Unknown DMC

• 1 other identifier: SH9H-2020-T122-2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.

Conditions

Tooth Diseases

Outcome Measures

Primary Outcomes (2)

• Accuracy

  Taking cone-beam computed tomography (CBCT). The deviation between the planned implant and the actual implant were measured by Computer Assisted Dental Implant Precision System (Dcarer, Suzhou, China) as follows: (1) At least four feature points (like tooth cusps or bone pits) were selected in preoperative and postoperative CBCT for rough registration. (2) Feature surface circles in preoperative CBCT were selected, and then a mathematical algorithm displayed a similar feature surface circle in postoperative CBCT. The algorithm registered thousands of points in these two circles via conventional iso-surface thresholding technology. The software calculated registration error automatically. (3) Finally, the planned and actual implant were identified, and the deviation would be automatically calculated.

  before surgery to after surgery one week

• Peri-implant soft tissue health

  Assessment of tissue health according to the definition of the 2017 International Classification. Berglundh et al.

  12-months follow-up after delivery of crown

Secondary Outcomes (7)

• Insetion torque value (ITV)

  surgery day

• Implant Stability Quotient (ISQ)

  surgery day

• Esthetic appearance of the dental crown

  12-months follow-up after delivery of the crown

• Patient satisfaction

  12-months follow-up after delivery of crown

• Peri-implant sulcus fluid Inflammation

  12-months follow-up after delivery of crown

Study Arms (2)

dynamic navigation

EXPERIMENTAL

Dental implant placement using a dynamic navigation system

Procedure: dynamic navigation surgery

freehand

SHAM COMPARATOR

Dental implant placement using freehand technique

Procedure: freehand surgery

Interventions

dynamic navigation surgery PROCEDURE

immediate implant placement using dynamic navigation

dynamic navigation

freehand surgery PROCEDURE

immediate implant placement using freehand surgery

freehand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old and in good health;
• The maxillary incisor that cannot be retained due to non-periodontitis;
• The buccal bone plate is complete;
• No acute infection;
• The extraction socket have at least 3-5 mm apical bone.

You may not qualify if:

• General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids);
• Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy);
• Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm;
• Heavy smokers or previous heavy smoking history (quit smoking time \<5 years or\> 20 cigarettes per day);
• Refuse to participate in this trial.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (3)

Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200011, China

Location

Department of Oral and Maxillofacial Implantology

Shanghai, Shanghai Municipality, 200011, China

Location

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

• Junyu Shi, PhD

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 11, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: July 31, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

CN (3)