CTRI

TITLE: Efficacy of implant placement with static guided versus dynamic navigation system on clinical and radiographical parameters-A comparative prospective clinical study.

PRINCIPAL INVESTIGATOR: Dr. Bhavya Manchala, Department of Periodontics, Vishnu dental college, Vishnupur, Bhimavaram.

NEED FOR STUDY: Conventional implant placement methods, such as freehand placement do not provide a reliable reproduction ofthe optimal planned implant position in the surgical site. As digital technology advances in the medical field, Computer Assisted Implant Surgery (CAIS) was introduced in 1995 to enable an accurate reproduction of the planned optimal implant position to the surgical site. CAIS works on the principle of using Computed Tomography (CT) in conjunction with implant planning software to simulate virtual implant placement in the optimal 3-dimensional position on multiplanar surfaces. When compared to conventional implant placement procedures, the accuracy of conveying the virtual implant position to the patient using static and dynamic CAIS systems has been found to be superior.

The purpose of the study is to measure the linear and angular deviations of implant placement in the mandibular posterior sites, thereby increasing the success of the implant and comparing the accuracy between static guided implant system and dynamic navigation system.

REVIEW OF LITERATURE:

1. Dechawat Kaewsirion et al - A study was conducted to compare the accuracy of implant placement between static and dynamic Computer Assisted Implant Surgery (CAIS) systems in single tooth space. A total of 60 implants are placed in partially edentulous patients in single tooth

2. Wu D, Zhou L et al - A retrospective study was done to compare the accuracy of dynamic navigation (DN) with a static surgical guide (SSG) for dental implant placement and the influence factors such as the experience of the surgeon and the implant sites of 38 implants, which underwent the dynamic navigation, and 57 implants which underwent a static surgical guide were enrolled. Coronal deviation and angular deviation were compared between the DN and SSG groups along with the difference experience level of surgeons and implant sites in the DN group. There were no statistically significant experience level of surgeons and implant sites in the DN group.However, the apical deviation of the DN was slightly higher than the SSG group in the anterior teeth and the angular deviation of DN was smaller than the SSG group in the molar spaces were randomly assigned to two CAIS groups and implants were placed by one surgeon. Primary outcomes were the deviation measurements at implant platform, apex, and angle of placement. Secondary outcome was the distribution of the implant deviation into each 3D direction. The angular deviation in static and dynamic CAIS group were 2.84 Â± 1.71 degrees and 3.06 Â±1.37 degrees. They concluded that Implant placement accuracy in single tooth space using dynamic CAIS appear to be the same to that of static CAIS.

AIM OF THE STUDY:To compare angular and linear deviations in posterior mandibular edentulous sites with static and dynamic navigation implant placement.

OBJECTIVES OF THE STUDY:

1)To assess the coronal linear deviation, apical linear deviation, depth linear deviation, Buccolingual angular deviation, Mesiodistal angular deviation using Implant planning software.

2)To assess implant stability using Resonance frequency analyser (RFA) at 3 months, crestal bone loss using Radiovisiography(RVG) at 3 and 6 months.

STUDY DESIGN:

Prospective comparative clinical study

24 patients were included in the study, with 15% loss of follow-up. Randomization will be done using coin toss method into two groups a)Test group: dynamic navigation b)Control group: Static guided.

STL files will be obtained either by scanning models or from intraoral scanner. Preoperative CBCT will be taken and DICOM files will be obtained. Merging of DICOM and STL files will be done using implant planning software. Guide will be designed and fabricated using software in static guided implant system and implant placement (4.5*10) will be done using the guide. In test group, Implant placement (4.5*10) will be done through Navigation. In both the groups, superimposition of preoperative and post operative CBCT will be done and deviations will be measured using respective software. Implant stability at 3 months and crestal bone loss will be measured at 3 months and 6 months.Finally, the results are statistically analysed.

DURATION OF STUDY:

2 years

SAMPLE SIZE:

N= 2 Sp2[Z1-Î±/2+Z1-Î²]2

Î¼d2

Sp2= S12+S22

S1 = Standard deviation in the first group = 1.85
S2 = Standard deviation in the second group = 1.11

SP2 = Pooled standard deviation

Î¼d2 = Mean difference between the samples = 1.2

Î± = significance level

Kaewsiri D, Panmekiate S, Subbalekha K, Mattheos N, Pimkhaokham A. The accuracy of staticvs. dynamic computer- assisted implant surgery in single tooth space: A randomized controlled trial. Clinical oral implants research. 2019 Jun;30(6):505-14.

SOURCE OF DATA:

Patients visiting Vishnu dental college for replacement of missing teeth and are willing for implants.

INCLUSION CRITERIA:

Age range of 18-75 years

Edentulous mandibular posterior sites

EXCLUSION CRITERIA :

Patients with uncontrolled systemic diseases

Pregnancy or lactating women

Chronic smokers

Patients with infectious diseases (HIV, Hepatitis B or Hepatitis C )

Known allergy to any component of the implant or implant guide

Patients undergoing radiation therapy

Patients under bisphosphonate therapy

REFERENCES:
Kaewsiri D, Panmekiate S, Subbalekha K, Mattheos N, Pimkhaokham A. The accuracy of staticvs. dynamic computerâ€assisted implant surgery in single tooth space: A randomized controlled trial. Clinical oral implants research. 2019 Jun;30(6):505-14.

Mediavilla GuzmaÌn A, Riad Deglow E, Zubizarreta-Macho AÌ, AgustiÌn-Panadero R, HernaÌndez Montero S. Accuracy of computer-aided dynamic navigation compared to computer- aided staticnavigation for dental implant placement: an in vitro study. Journal of clinical medicine. 2019 Dec;8(12):2123

Wu D, Zhou L, Yang J, Zhang B, Lin Y, Chen J, Huang W, Chen Y. Accuracy of dynamic navigation compared to static surgical guide for dental implant placement. International Journal ofImplant Dentistry. 2020 Dec;6(1):1-8.

Block MS, Emery RW, Lank K, Ryan J. Implant Placement Accuracy Using Dynamic Navigation.International Journal of Oral & Maxillofacial Implants. 2017 Jan 1;32(1).