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CTRI Number  CTRI/2024/08/072287 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Different Ways to Make Temporary Dental Crowns and Their Effects on Gum Health in Various Situations: A Clinical Study 
Scientific Title of Study   Evaluation of soft and hard tissue conditioning with provisional crowns fabricated by using Additive and Subtractive manufacturing techniques in various clinical scenarios: A split mouth randomized clinical trial 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Happy Patel 
Designation  MDS Student 
Affiliation  Narsinhbhai Patel Dental College and Hospital 
Address  3,Department of Prosthodontics Narsinhbhai Patel Dental College and Hospital Sakalchand Patel University Visnagar


GUJARAT
384315
India 
Phone  9429239099  
Fax    
Email  happypatel2310.hp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sareen Duseja 
Designation  Professor and Head  
Affiliation  Narsinhbhai Patel Dental College and Hospital 
Address  3,Department of Prosthodontics, Narsinhbhai Patel Dental College and Hospital Sakalchand Patel University Visnagar


GUJARAT
384315
India 
Phone  9979961730  
Fax    
Email  drsareenduseja@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sareen Duseja 
Designation  Professor and Head  
Affiliation  Narsinhbhai Patel Dental College and Hospital 
Address  3,Department of Prosthodontics,Narsinhbhai Patel Dental College and Hospital Sakalchand Patel University Visnagar


GUJARAT
384315
India 
Phone  9979961730  
Fax    
Email  drsareenduseja@gmail.com  
 
Source of Monetary or Material Support  
Narsinhbhai Patel Dental College and Hospital Sankalchand Patel University Visnagar 384315 
 
Primary Sponsor  
Name  Dr Happy Patel 
Address  Narsinhbhai Patel Dental College and Hospital Sakalchand Patel University Visnagar 384315 
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 Happy Patel  Narsinhbhai Patel Dental College and Hospital  Department of Prosthodontics and Crown and Bridge
Mahesana
GUJARAT 		 9429239099

happypatel2310.hp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patient who is having edodontically treated anterior Dentition 
Patients  (1) ICD-10 Condition: K042||Pulp degeneration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Provisional Crowns  Temporary Crowns fabricated by Additive manufacturing (3D printing)  
Comparator Agent  Provisional crowns  temporary crowns fabricated by Subtractive manufacturing (CAD/CAM) 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients in good general health without chronic systemic disease
2)Intact teeth & Endodontically treated teeth in the anterior region of jaws
 
 
ExclusionCriteria 
Details  1)Clinical attachment loss
2)Poor oral hygiene
3)Parafunctional habits such as Bruxism
4)Inability or unwillingness to return for follow up visits
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1) Patient Satisfaction and comfort
2) Improve Gingival Health 		 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease Gingival Inflammation  6 months 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   20/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [happypatel2310.hp@gmail.com].

  6. For how long will this data be available start date provided 23-10-2025 and end date provided 23-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
          Provisional crowns are temporary crowns that are used in prosthetic dental treatments. They serve important purposes & sometimes it can be in place for an extended period of time in such cases: temporomandibular disorder & periodontal disease. Provisional crowns are crucial in successful prosthetic treatments. They offer benefits such as tooth protection, esthetics, treatment planning assistance, tissue conditioning, TMJ stability & patient satisfaction during the interim period. The fabrication method and materials used which influence the properties of the provisional crowns. so
the aim of this split-mouth study is to evaluate the soft & hard tissue changes in anterior teeth region when restored with PMMA provisional crowns fabricated by Additive & Subtractive manufacturing techniques.
 
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