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CTRI Number  CTRI/2025/02/081361 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Other (Specify) 
Study Design  Other 
Public Title of Study   Comparison between conventional impressions and digital scans. 
Scientific Title of Study   Comparative assessment of patient experience, time, and accuracy (for measuring the mesio-distal width of teeth) using two different methods of record-making, using alginate impressions and intraoral scans: an in vivo 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 Vinnayakk Kalaskar 
Designation  Postgraduate student 
Affiliation  SMBT Dental College and Hopsital 
Address  Department no.303, Third floor, SMBT Dental College and Hopsital, Ghulewadi, Sangamner-422608, Maharashtra, India.

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  8605068056  
Fax    
Email  kalaskarvinayak5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hrushikesh Aphale  
Designation  Professor 
Affiliation  SMBT Dental College and Hopsital 
Address  Department no.303, Third floor, SMBT Dental College and Hopsital, Ghulewadi, Sangamner-422608, Maharashtra, India.

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  8806807124  
Fax    
Email  hrushiaphale@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hrushikesh Aphale 
Designation  Professor 
Affiliation  SMBT Dental College and Hopsital 
Address  Department no.303, Third floor, SMBT Dental College and Hopsital, Ghulewadi, Sangamner-422608, Maharashtra, India.

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  8806807124  
Fax    
Email  hrushiapahale@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthodontics and Dentofacial Orthopedics, SMBT Dental College and Hospital Ghulewadi, Sangamner, Maharashtra , India, 422608. 
 
Primary Sponsor  
Name  Dr Vinnayakk Kalaskar 
Address  Depatment of Orthodontics and Dentofacial Orthopaedics, Department no. 303, third floor, SMBT Detal College and Hopstal, Ghulewadi, Sangamner 422608, Maharashtra, India.  
Type of Sponsor  Other [Self funded] 
 
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 Vinnayakk Kalaskar  SMBT Dental College and Hoospital  Depatment of Orthodontics and Dentofacial Orthopaedics, Department no. 303, third floor, SMBT Detal College and Hopstal, Ghulewadi, Sangamner 422608, Maharashtra, India
Ahmadnagar
MAHARASHTRA 		 8605068056

kalaskarvinayak5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee, SMBT 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: K03||Other diseases of hard tissues ofteeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Alginate impression  Alginate impressions will be recorded for the patients, with time being calculated for the same.Frequency: At Baseline, 1 month and 3 months. Total Duration: 3 months 
Intervention  Intra oral scanner   Digital scans will be recorded on patients with the help of a digital intraoral scanner. time will be calculated for the same. Frequency: At Baseline, 1 month and 3 months. Total Duration: 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patient in age group above 18-25 years.
Patient willing to sign the consent.
Patient having minimal crowding or no crowding.  
 
ExclusionCriteria 
Details  Patient below 18 years of age.
Patient having previous experience of intraoral scanning.
Patient having previous experience of alginate impression.
Allergies to any laser/light type of source.
Patient with missing teeth.
Patient with multiple extensive decay, grossly destructed teeth and severely mobile teeth 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Accuracyfor both impression record-making techniques using intraoral scan and alginate   baseline and 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Patient time and experience using two different methods of record-making using alginate impressions and intraoral scans.  baseline and 3 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 
Date of First Enrollment (India)   17/03/2025 
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   Orthodontic study models have long been a crucial component of the procedure. Dental models are utilized in diagnostic and treatment planning processes, including space assessment, appliance design and manufacture, treatment impact evaluation, modeling of tooth and jaw motions, and assessment of tooth locations and occlusal connections. In the past, dental impressions were created using impression materials, but with time, 3D imaging systems were developed. Alginate, out of all the imprint materials, is most frequently employed to capture intraoral anatomy for orthodontic appliance production and diagnostics in orthodontic treatment planning. Although traditional alginate imprints may be used to create dental models, more recent developments have made it possible to create orthodontic appliances using intraoral scanners. There are advantages to alginate as weel intraoral scanners followwing with their own learning curves and their disadvantages too in their own way. Morphology is commonly measured in orthodontics based on patient-centered variables and adoption of various record-keeping techniques. Dental casts are used for orthodontic diagnosis and treatment planning, which involves measuring the tooth’s mesio-distal breadth. In order to determine which of the two record-making techniques provides accurate measurements that are close to the actual dimensions of the dentition, this study focuses on comparing the two methods that prioritize patient preference and acceptance while documenting patient experience, as well as the time required for each method. 

 
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