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CTRI Number  CTRI/2025/06/088857 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 13/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Testing a new method for more accurate digital scans of full-mouth dental implants 
Scientific Title of Study   Accuracy of complete arch digital implant impressions with and without scan body splinting using modular chain - A clinical trail 
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 Parikeerthan Y P 
Designation  Post graduate student 
Affiliation  Bapuji dental college and hospital 
Address  Room no 7 department of prosthodontics and crown and bridge bapuji dental college and hospital
Mcc B block Davangere - 577004
Davanagere
KARNATAKA
577004
India 
Phone  9972935644  
Fax    
Email  parikeerthan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Parikeerthan Y P 
Designation  Post graduate student 
Affiliation  Bapuji dental college and hospital 
Address  Room no 7 department of prosthodontics and crown and bridge bapuji dental college and hospital
Mcc B block Davangere - 577004

KARNATAKA
577004
India 
Phone  9972935644  
Fax    
Email  parikeerthan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sunitha N Shamnur 
Designation  Professor 
Affiliation  Bapuji dental college and hospital 
Address  Room no 7 department of prosthodontics and crown and bridge bapuji dental college and hospital
Mcc B block Davangere - 577004
Davanagere
KARNATAKA
577004
India 
Phone  9449822941  
Fax    
Email  shamnursunithan@gmail.com  
 
Source of Monetary or Material Support  
Bapuji dental college and hospital 
 
Primary Sponsor  
Name  self  
Address  Room number 7 department of prosthodontics and crown and bridge bapuji dental college and hospital davangere 
Type of Sponsor  Other [investigator] 
 
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 Sunitha N Shamnur  Bapuji dental college and hospital  Department of prosthodontics and crown and bridge room number 7
Davanagere
KARNATAKA 
9449822941

shamnursunithan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bapuji dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K081||Complete loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Modular E- Chain  The patients intra oral scanning will be done by connecting the modular E - chain passively to the scan bodies 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with full arch implant placed with ISQ value greater then or equal to 60 
 
ExclusionCriteria 
Details  Patients with limited mouth opening 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Accurate scanned data will be obtained by splinting  Base line 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/07/2025 
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="0"
Months="3"
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  

This study aims to assess and compare the accuracy of complete arch digital implant impressions, both with and without the use of a modular E-chain for splinting scan bodies.

In contemporary prosthodontics, precise implant impressions are crucial for the long-term success of implant-supported prostheses. Digital impression techniques using intraoral scanners offer advantages over traditional methods in terms of ease and accuracy. Splinting of impression copings or scan bodies is a recognized technique to enhance stability and accuracy, especially for complete arch impressions involving four or more implants. While various materials have been used for splinting, modular chains have emerged as a promising alternative due to their ease of use, stability, and ability to improve scanning reference points, overcoming limitations of traditional resins and dental floss.

The study will involve patients visiting the Department of Oral Implantology. Patients meeting specific inclusion criteria, such as having full arch implants with an ISQ value greater than or equal to sixty, will be selected. Exclusion criteria include patients with limited mouth opening.

The methodology involves three main steps:

  1. Master Reference Model Preparation: A conventional impression will be taken, and a master cast will be created. This cast will be indirectly scanned using a laboratory scanner to generate a highly accurate Standard Tessellation Language (STL) file, serving as the master reference.
  2. Intraoral Scanning Procedure: Patients will undergo two intraoral scans using a Dentsply Sirona Primescan. First, scan bodies will be scanned without the modular E-chain. Second, the scan bodies will be passively connected with the modular E-chain and then scanned. Two separate STL files will be obtained from these scans.
  3. Data Processing and Accuracy Assessment: All generated STL files (from scans with and without the modular E-chain) will be aligned with the master reference STL file using Geomagic Studio 12 software. The software will then be used to measure and compare the linear deviations in the x, y, and z axes (in micrometers) and angular deviations (in degrees) between the scanned models and the master reference.

The primary objective is to determine if there is a significant difference in linear and angular deviation between digital implant impressions taken with and without modular E-chain splinting. The research hypothesis anticipates a difference, while the null hypothesis states there will be no difference. An independent Student’s t-test will be used for statistical analysis, with a p-value less than 0.05 indicating statistical significance. The total sample size will be six patients, calculated based on previous research.

 
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