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临床试验/CTRI/2022/09/046095
CTRI/2022/09/046095尚未招募不适用

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

Bhavya Manchala1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年5月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
3. Apex deviation (V)

研究概览

简要总结

TITLE: Efficacy of implant placement with static guidedversus dynamic navigation system on clinical andradiographical parameters-A comparativeprospective clinical study.

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

NEED FOR STUDY: Conventional implant placement methods, such as freehandplacement do not provide a reliable reproduction ofthe optimalplanned implant position in the surgical site. As digital technologyadvances in the medical field, Computer Assisted Implant Surgery(CAIS) was introduced in 1995 to enable an accurate reproductionof the planned optimal implant position to the surgical site. CAISworks on the principle of using Computed Tomography (CT) inconjunction with implant planning software to simulate virtualimplant placement in the optimal 3-dimensional position onmultiplanar surfaces. When compared to conventional implantplacement procedures, the accuracy of conveying the virtualimplant position to the patient using static and dynamic CAISsystems 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 theaccuracy between static guided implant system and dynamicnavigation system.

REVIEW OF LITERATURE:

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

2. Wu D, Zhou L et al - A retrospective study was done tocompare the accuracy of dynamic navigation (DN) with astatic surgical guide (SSG) for dental implant placementand the influence factors such as the experience of thesurgeon and the implant sites of 38 implants, which underwent the dynamic navigation, and 57 implants which underwent a static surgical guide were enrolled. Coronaldeviation 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 andimplants were placed by one surgeon. Primary outcomeswere the deviation measurements at implant platform,apex, and angle of placement. Secondary outcome was thedistribution of the implant deviation into each 3Ddirection. The angular deviation in static and dynamicCAIS group were 2.84 ± 1.71 degrees and 3.06 ±1.37degrees. They concluded that Implant placement accuracyin single tooth space using dynamic CAIS appear to be thesame to that of static CAIS.

AIM OF THE STUDY:To compare angular and linear deviations in posterior mandibularedentulous sites with static and dynamic navigation implantplacement.

OBJECTIVES OF THE STUDY:

1)To assess the coronal linear deviation, apical lineardeviation, depth linear deviation, Buccolingual angulardeviation, Mesiodistal angular deviation using Implantplanning software.

2)To assess implant stability using Resonance frequencyanalyser (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-α/2+Z1-β]2

μd2

Sp2= S12+S22

2

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

SP2 = Pooled standard deviation

μd2 = Mean difference between the samples = 1.2

α = significance level

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

SOURCE OF DATA:

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

INCLUSION CRITERIA:

Age range of 18-75 years

Edentulous mandibular posterior sites

EXCLUSION CRITERIA :

    1. Patients with uncontrolled systemic diseases
  1. Pregnancy or lactating women
  2. Chronic smokers
  3. Patients with infectious diseases (HIV, Hepatitis B or Hepatitis C )
  4. Known allergy to any component of the implant or implant guide
  5. Patients undergoing radiation therapy
  6. Patients under bisphosphonate therapy

REFERENCES: 2. 1. Kaewsiri D, Panmekiate S, Subbalekha K, Mattheos N,Pimkhaokham A. The accuracy of staticvs. dynamiccomputerâ€assisted implant surgery in single tooth space: Arandomized controlled trial. Clinical oral implants research.2019 Jun;30(6):505-14. 2. Mediavilla GuzmaÌn A, Riad Deglow E, Zubizarreta-MachoAÌ, AgustiÌn-Panadero R, HernaÌndez Montero S. Accuracy ofcomputer-aided dynamic navigation compared to computer-aided staticnavigation for dental implant placement: an invitro study. Journal of clinical medicine. 2019 Dec;8(12):2123 3. Wu D, Zhou L, Yang J, Zhang B, Lin Y, Chen J, Huang W,Chen Y. Accuracy of dynamic navigation compared to staticsurgical guide for dental implant placement. InternationalJournal ofImplant Dentistry. 2020 Dec;6(1):1-8. 4. Block MS, Emery RW, Lank K, Ryan J. Implant PlacementAccuracy Using Dynamic Navigation.International Journal ofOral & Maxillofacial Implants. 2017 Jan 1;32(1).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Edentulous mandibular posterior sites.

排除标准

  • 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 7.

结局指标

主要结局

3. Apex deviation (V)

时间窗: T1-0 days-Preoperative assessment | T2-0 days-Postoperative assessment (immediately after implant placement on the same day)

4. Angular deviation

时间窗: T1-0 days-Preoperative assessment | T2-0 days-Postoperative assessment (immediately after implant placement on the same day)

1. Entry deviation

时间窗: T1-0 days-Preoperative assessment | T2-0 days-Postoperative assessment (immediately after implant placement on the same day)

2. Apex deviation (3D)

时间窗: T1-0 days-Preoperative assessment | T2-0 days-Postoperative assessment (immediately after implant placement on the same day)

次要结局

  • Crestal bone loss(Implant stability)

研究者

发起方
Bhavya Manchala
申办方类型
Other [self]

研究点 (1)

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