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

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)

Overall Status

Completed

CT.gov ID

NCT04999956

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tooth Diseases	Procedure: dynamic navigation Procedure: freehand	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Accuracy and Primary Stability in Immediate Implant Placement Using Dynamic Navigation or Freehand

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dynamic navigation	Procedure: dynamic navigation immediate implant placement using dynamic navigation
Sham Comparator: freehand	Procedure: freehand immediate implant placement using freehand

Arm

Intervention/Treatment

Experimental: dynamic navigation

Procedure: dynamic navigation

immediate implant placement using dynamic navigation

Sham Comparator: freehand

Procedure: freehand

immediate implant placement using freehand

Outcome Measures

Primary Outcome Measures

Accuracy [before surgery to after surgery one week]
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.

Secondary Outcome Measures

Insetion torque value (ITV) [surgery day]
A general method to to detect primary stability roughly. The ITV were evaluated by a wrench (Straumann, Waldenburg, Switzerland) at the time of implant placement. The investigator record the number of scale. Being equal to or greater than 35N is a ideal primary stability.
Implant Stability Quotient (ISQ) [surgery day]
A device to detect primary stability precisely. A Smartpeg was screwed into each implant, and resonance frequency analysis (RFA) was performed using Osstell Mentor (Osstell/Integration Diagnostics, Goteborg, Sweden). ISQ were recorded in the buccal and the palatal directions three times and averaged. <60 represents low stability; 60-70 represents medium stability; higher than 70 represents high stability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

≥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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Ninth People's Hospital	Shanghai	Shanghai	China	200011

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Junyu Shi, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

ClinicalTrials.gov Identifier:

NCT04999956

Other Study ID Numbers:

SH9H-2020-T122-2

First Posted:

Aug 11, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tooth Diseases

Study Results

No Results Posted as of Mar 31, 2022