FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/10/046494 [Registered on: 14/10/2022] Trial Registered Prospectively
Last Modified On: 12/10/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparision Between The Accuracy of Implants Placed in Weaken Upper Jaw Using Conventional Method and Computerised Method 
Scientific Title of Study   Accuracy Of Dynamic Navigation And Free Hand Surgery Using Zygomatic Implants For Rehabilitation Of Atrophic Maxilla - A Split Mouth Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gautami S Penmetsa 
Designation  Professor and Head 
Affiliation  Vishnu Dental College 
Address  Room no. 7, Department of Periodontics Vishnu Dental College Vishnupur Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9951011618  
Fax    
Email  gautamipenmetsa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul Manhar Shah 
Designation  Private Practitioner 
Affiliation  Sahyog Maxillofacial Center, Thane, Maharashtra 
Address  Office 1A, Madhuban CHS behind ICICI Bank, Eastern Expressway Highway Service Road, Panch Pakhdi, Thane

Thane
MAHARASHTRA
400602
India 
Phone  9820775127  
Fax    
Email  drrahulshah88@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Manhar Shah 
Designation  Private Practitioner 
Affiliation  Sahyog Maxillofacial Center, Thane, Maharashtra 
Address  Office 1A, Madhuban CHS behind ICICI Bank, Eastern Expressway Highway Service Road, Panch Pakhdi, Thane

Thane
MAHARASHTRA
400602
India 
Phone  9820775127  
Fax    
Email  drrahulshah88@gmail.com  
 
Source of Monetary or Material Support  
Sahyog Maxillofacial Center, Office 1A, Madhuban CHS behind ICICI Bank, Eastern Expressway, Highway, Service Rd, Panch Pakhdi, Thane, Maharashtra 400602 
 
Primary Sponsor  
Name  Dr Gautami S Penmetsa 
Address  Room no 7, Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rahul Manhar Shah  Sahyog Maxillofacial centre  Office 1A Madhuban CHS behind ICICI Bank Eastern Expressway Highway Service Rd Panch Pakhdi Thane Thane
Thane
MAHARASHTRA 		 9820775127

drrahulshah88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dynamic Navigation System   Zygomatic Implants will be placed using Dynamic Navigation System (Navident by ClaroNav). Time duration taken for placement will be 45 - 60 minutes  
Comparator Agent  Free hand method   Zygomatic Implants will be placed using Free Hand Method. Time duration taken for placement will be 30-45 minutes.  
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  67.00 Year(s)
Gender  Both 
Details  1.22 to 67 years
2.Systemically healthy patients  
 
ExclusionCriteria 
Details  1.Pregnant and lactating women
2.Uncontrolled systemic diseases
3.Habit of smoking and chewing tobacco
4.Patients with infectious diseases(HIV Hepatitis B)
5.Patients undergoing radiation therapy and Bisphosphonate therapy and steroid therapy
6.Known allergy to the implant or implant guide  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Entry deviation(mm)
Apex deviation(3D)(mm)
Apex deviation(V)(mm)
Angular Deviation (degrees) 		 T0: 0 days- Postoperative assessment of implant deviation immediately after placement Entry deviation(mm)
Apex deviation(3D)(mm)
Apex deviation(V)(mm)
Angular Deviation (degrees) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   TITLE: Accuracy Of Dynamic Navigation And Free Hand Surgery Using Zygomatic Implants For Rehabilitation Of Atrophic Maxilla - A Split Mouth Study.

PRINCIPAL INVESTIGATOR: Dr. Gautami S Penmetsa, Professor and Head,  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 of the 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 dynamic CAIS systems has been found to be superior. The purpose of the study is to measure the linear and angular deviations of zygomatic implant placement in the atrophic maxilla , thereby increasing the success of the implant and comparing the accuracy between freehand method and dynamic navigation system.

REVIEW OF LITERATURE:
1) A prospective controlled clinical trail conducted by Ashwini et al in the year  2022, inserted zygomatic implants using Dynamic navigation system. A Test group and control group of 20 patients are included. In test group, dynamic navigation guided insertion of zygomatic implants with the reflection of the mucoperiosteal flap was performed. In the control group, flapless insertion of the zygomatic implants was performed. They concluded that Dynamic navigation -guide insertion of zygomatic implants was effective in maxillary rehabilitation.

2) A study conducted by Yiqun Wu et al  included patients who presented with severely maxillary atrophy or maxillary defects and received dynamic navigation-supported ZI surgery. The deviations of entry, exit, and angle were measured after image data fusion. 71 patients with 221 ZIs received Zygomatic implants placed using navigation-guided surgery. The deviations in entry, exit, and angle were 1.57 ± 0.71 mm, 2.1 ± 0.94 mm and
2.68 ± 1.25 degrees, respectively. Patients with atrophic maxillary or maxillary defects showed a significant difference in exit deviation. They concluded that the navigation-supported ZI implantation is an accurate and reliable method for zygomatic implant placement.

AIM OF THE STUDY: To compare angular and linear deviations in zygomatic implants placed using freehand method and dynamic navigation system in the same patient.

OBJECTIVES OF THE STUDY: To assess the entry deviation, apical deviation(3D), apical deviation(V), Angular deviation using Implant planning software.

STUDY DESIGN: Prospective comparative clinical study 
40 patients were included in the study. Randomization will be done using coin toss method into two groups a)Test group: dynamic navigation b)Control group: Freehand method
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.  In test group,  Zygomatic Implant placement  will be done through Navigation system. In control group, the zygomatic implants will be placed using freehand method.  In both the groups, superimposition of preoperative and post operative CBCT will be done and deviations will be measured using respective software.

DURATION OF STUDY: 2 Months

SAMPLE SIZE: The sample size was calculated using the G*power 3.1 software. The calculations were based on the mean angular deviation as primary outcome with an effect size of 1.4, an alpha level of 0.05 and an 80% desired power for 2 paired means with a 1:1 allocation ratio, assuming normality, for a 2-sided test with a split-mouth design. The sample size was set at 20 implants in 10 subjects.

SOURCE OF DATA: Patients visiting Sahyog Maxillofacial centre for rehabilitation of Atrophic Maxilla.

INCLUSION CRITERIA: 
1)22 to 67 years
2)Systemically healthy patients
EXCLUSION CRITERIA : 
1)Pregnant and lactating women
2)Uncontrolled systemic diseases
3)Habit of smoking and chewing tobacco
4)Patients with infectious diseases(HIV Hepatitis B)
5)Patients undergoing radiation therapy and Bisphosphonate therapy and steroid therapy
6)Known allergy to the implant or implant guide
REFERENCES:
1. Bhalerao A, Ayoub A. Zygomatic implants using dynamic navigation. Journal of Dentistry. 2022 Jun 1;121:103993.
2. Wu Y, Tao B, Lan K, Shen Y, Huang W, Wang F. Reliability and accuracy of dynamic navigation for zygomatic implant placement. Clinical Oral Implants Research. 2022 Apr;33(4):362-76.  
 
 
Close