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CTRI Number  CTRI/2025/12/099188 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 01/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparitive study 
Study Design  Other 
Public Title of Study   A study to compare the Accuracy of Conventional and Digital Implant Impressions in Missing Teeth 
Scientific Title of Study   Assessment of accuracy in Conventional versus Digital Implant Level Impression Technique in Partially Edentulous Arches: A Comparative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J Soumya 
Designation  Post Graduate Student 
Affiliation  Faculty of Dental Sciences ,Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics,Room no 4 ,1st floor,faculty of Dental sciences,Ramaiah University of Applied Sciences,NEW BEL Road

Bangalore
KARNATAKA
560054
India 
Phone  7019451164  
Fax    
Email  jsoumya60@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gayathri Devi S K 
Designation  Assistant Professor 
Affiliation  Faculty of Dental Sciences ,Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics,Room no 4 ,1st floor,faculty of Dental sciences,Ramaiah University of Applied Sciences,NEW BEL Road

Bangalore
KARNATAKA
560054
India 
Phone  9886762183  
Fax    
Email  gayathridevi@msruas.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr J Soumya 
Designation  Post Graduate Student 
Affiliation  Faculty of Dental Sciences ,Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics,Room no 4 ,1st floor,faculty of Dental sciences,Ramaiah University of Applied Sciences,NEW BEL Road

Bangalore
KARNATAKA
560054
India 
Phone  7019451164  
Fax    
Email  jsoumya60@gmail.com  
 
Source of Monetary or Material Support  
Department of Prosthodontics,Room no 4,1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Bangalore, Karnataka, India, Pincode- 560054 
 
Primary Sponsor  
Name  Dr. J Soumya 
Address  Faculty of Dental Sciences, Ramaiah University of Applied Sciences, NEW BEL Road, Bengaluru, Karnataka, 560054 
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 J Soumya  Ramaiah Dental Hospital  Department of Prosthodontics, Room no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences,New BEL Road, MSR Nagar Banglore
Bangalore
KARNATAKA 
7019451164

jsoumya60@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee for Human Trials Approval Certificate   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Partially edentulous arch 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional impression using Laboratory Scanner  Patients requiring implant crowns with adjacent implants will be subjected to conventional impression using Open tray impression technique and Scanned using Laboratory Scanner 
Intervention  TRIOS 3SHAPE intra oral Scanner   Patients requiring implant crowns with two adjacent implants will be scanned with Trios 3shape intra oral scanner  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Both maxillary and mandibular arch
2. Dental arches with two or more adjacent missing teeth in anterior or posterior region.
3. Dental Implant with diameters ranging from 3.2 mm to 5 mm
 
 
ExclusionCriteria 
Details  1. Patients with Chronic Systemic diseases affecting the bone healing or implant stability such as osteoporosis
2. Patients with uncontrolled diabetes, bleeding disorders, recent myocardial infarction and other immunocompromised conditions.
3. Chronic smokers, tobacco chewers
4. Lactating and pregnant women
5. Mini-implants of diameter lesser than 3mm
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the accuracy (inter-implant distance, linear deviation, angular deviation) of conventional and digital impressions  Not applicable 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the patient satisfaction for both the groups   
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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)   30/12/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Dental implants are the most preferred treatment options for restoring missing teeth, and accurate impressions are crucial for achieving a passively fitting prosthesis. The precision of the implant impression is affected by factors like materials, technique, splinting, level, depth, and implant angle. The goal is to accurately reproduce implant locations in three dimensions as well as in relation to the other intraoral hard and soft tissue structures.

Conventional impression methods, which have been used for years, are associated with limitations such as dependence on operator skill and multiple clinical and laboratory steps (Heckmann et al., 2004). The advancement of digital technology in dental impressions, including the introduction of intraoral scanners, offers the potential for enhanced efficiency, greater patient comfort, and a minimized risk of human error. (Gjevold et al., 2016; Delize et al., 2019).

In recent years, significant advancements have been made in dental implant impressions, aiming to enhance the accuracy of the prosthetic reconstruction process. Several literatures are available for in vitro studies regarding digital impressions in implants. However, there are very few in-vivo studies comparing digital and conventional impression techniques. Hence, the present study will be undertaken to evaluate the accuracy of conventional versus digital implant-level impression techniques in partially edentulous arches in a clinical scenario.

Aim of the study: To evaluate and compare the accuracy of digital implant level impression technique with conventional implant level impression technique in partially edentulous clinical situations.

 

Objectives of the study:

1.To obtain the STL file from conventional and digital implant level impression technique.

2.To compare the accuracy (inter implant distance, linear and angular deviation) of digital and conventional implant level impression techniques.

 

 
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