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CTRI Number  CTRI/2024/10/074847 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 05/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare accuracy of multiple implant impressions in terms of trueness, precision and angle deviation in digital and splinted closed tray with splinted open tray impression method. 
Scientific Title of Study   Comparative Evaluation Of Accuracy in Terms of Trueness, Precision and Angle deviation of Multiple Implant Impressions in Digital and Splinted Closed Tray With Splinted Open Tray Impression Method: A Randomised Controlled Clinical Trial 
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 Rutuja Deshmukh 
Designation  Post Graduate Student 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India 
Phone  7058228684  
Fax    
Email  deshmukh.rutuja24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishankumar Lahoti 
Designation  Reader and PG Guide 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India 
Phone  9763711501  
Fax    
Email  kk.lahoti@sdk-dentalcollege.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Rutuja Deshmukh 
Designation  Post Graduate Student 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India

MAHARASHTRA
441110
India 
Phone  7058228684  
Fax    
Email  deshmukh.rutuja24@gmail.com  
 
Source of Monetary or Material Support  
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India 
 
Primary Sponsor  
Name  Dr Rutuja Deshmukh 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India 
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 Rutuja Deshmukh  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital  104, Department Of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur, Maharashtra Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 
7058228684

deshmukh.rutuja24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee- Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur 441110  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: PCS||, (3) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  closed tray impression method  it is a conventional implant impression method used to make implant impression. Closed tray impression copings will be used and will splint it with floss and BIS GMA resin to make impression. Cast will be poured using type IV gypsum and will be assessed after a day.  
Intervention  digital impression method  intraoral scanner is used to make implant impression. Scan bodies will be fixed to implant and digital impression will be made 
Comparator Agent  splinted open tray impression method  it is a conventional implant impression method used to make implant impression. open tray impression copings will be used and will splint it with floss and BIS GMA resin to make impression. Cast will be poured using type IV gypsum and will assessed after a day.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients with the age group of ≥ 18 to 70 years.
2.Patients irrespective of gender will be selected.
3.Partially edentulous patient having unilaterally placed two or more implants.
4.Volunteer patients who agree to give informed consent will be considered
as individuals for the research.
 
 
ExclusionCriteria 
Details  1.Patients requiring fixed implant prosthesis on single implant.
2.Patients having bilaterally placed single implants.
3.Completely edentulous patients.
4.Patients having a neuromuscular disorder. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To evaluate the accuracy of multiple implant impression in terms of trueness, precision
and angle deviation using digital method.
2) To evaluate the accuracy of multiple implant impression in terms of trueness, precision
and angle deviation using splinted closed tray impression.
3) To evaluate the accuracy of multiple implant impression in terms of trueness, precision
and angle deviation using splinted open tray impression method. 
At first the accuracy of multiple implant impression
using digital method will be obtained.
secondly the accuracy of multiple implant impression
using splinted closed tray impression will be obtained.
Then the accuracy of multiple implant impression using splinted open tray impression method will be obtained.
The accuracy of the impression method will be assessed after a day.
 
 
Secondary Outcome  
Outcome  TimePoints 
1) To compare the accuracy in terms of trueness, precision & angle deviation of multiple
implant impression using digital & splinted closed tray impression with splinted open
tray impression method. 
The inter implant distance between two or more implant will be measured using
coordinate measuring machine in x, y & z axis of all the obtained casts.
Obtained data will be uploaded to the Software & accuracy will be evaluated &
compared within a week. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   21/10/2024 
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="1"
Months="6"
Days="2" 
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  
The objective of contemporary dentistry is to return patients to a state of normal contour, function, comfort, aesthetics, speech, and health, whether it involves restoring a single tooth or replacing multiple teeth. As the number of missing teeth increases in a patient, achieving this goal becomes increasingly challenging. Osseointegrated Dental implants have provided better treatment option for individuals who have lost their teeth, serving as an alternative to traditional prostheses. The positioning of implants is dictated by the anatomy of the remaining ridges. These implants have demonstrated promising long-term outcomes for patients. Creating impressions is a fundamental aspect of prosthesis fabrication. The choice of impression material and technique significantly impacts the fit of the prosthesis. Accurately transferring the spatial relationships of implants from the oral cavity to the master cast through the impression process is the initial and vital step to ensure a passive fit of the implant framework. Various impression techniques are recommended to create a master cast ensuring the passive fit of implant-supported prostheses. Two conventional methods include the open tray method (Direct method /pick-up impression technique) and the closed tray method (Indirect method /transfer impression technique). Conventional implant impression using elastomeric impression material have been a standard procedure for fixed prosthodontics for a long time however, digital implant impressions using intraoral scanners (IOS) are a comparatively recent but steadily advancing technique. The utilization of intraoral scanners is on the rise, particularly for implant-supported fixed dental prostheses. Intraoral scan bodies essentially function to transfer the intraoral implant position to the digital model.
Primary Objectives:- 1) To evaluate the accuracy of multiple implant impression in terms of trueness, precision and angle deviation using digital method. 2) To evaluate the accuracy of multiple implant impression in terms of trueness, precision and angle deviation using splinted closed tray impression. 3) To evaluate the accuracy of multiple implant impression in terms of trueness, precision and angle deviation using splinted open tray impression method. Method of measurement:  The 36 candidates will be selected according to the inclusion and exclusion criteria. Digital impression, splinted closed tray, splinted open tray impression and will be made. Intraoral scanning will be done according to the manufacturer’s instructions. Implant Impression of patients with partial edentulous arch with two or more implants placed unilaterally will be made. Digital impression method: The scan bodies will be affixed to the implants. Intraoral scanning will be performed according to the manufacturer’s instructions.  Subsequently, a Standard Tessellation Language (STL) file will be generated from the scan data. Finally, a model will be fabricated based on the digital scan using 3D printer. splinted open tray and closed tray impression coping will be used for respective impression techniques and it will be splinted using dental floss and BIS-GMA resin. The inter-implant distance between two or more implant will be measured using coordinate measuring machine in x, y and z axis of all the obtained casts. Obtained data will be uploaded to the Software and accuracy will be evaluated and compared. The series of operations will be performed on all combinations of the type IV gypsum casts for open and closed tray impressions and digital model sets for each patient. Obtained data will be evaluated and compared amongst the group based on trueness, precision and angle deviation of every impression technique.
 
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