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CTRI Number  CTRI/2024/09/074333 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 09/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   evaluation of the accuracy of implant crown fabricated by two different methods 
Scientific Title of Study   Comparative evaluation of marginal and internal fit of single posterior implant retained crown fabricated using conventional and digital impression workflow- 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  Prerna Suresh Kalyani 
Designation  Postgraduate student 
Affiliation  KLE VK INSTITUTE OF DENTAL SCIENCE 
Address  Department number 3, Department of prosthodontics crown and bridge ground floor, KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar Belgaum KARNATAKA 590010 Belgaum
K.L.E.V.K.INSTITUE OF DENTAL SCIENCE,
Belgaum
KARNATAKA
590010
India 
Phone  07020049533  
Fax    
Email  prernakalyani95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anankumar.G Patil 
Designation  Professor 
Affiliation  KLE VK INSTITUTE OF DENTAL SCIENCE 
Address  Department number 3, Department of prosthodontics crown and bridge ground floor, KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar Belgaum KARNATAKA 590010 Belgaum
K.L.E.V.K.INSTITUE OF DENTAL SCIENCE,
Belgaum
KARNATAKA
590010
India 
Phone  8792650805  
Fax    
Email  patilprostho@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prerna Suresh Kalyani 
Designation  Postgraduate student 
Affiliation  KLE VK INSTITUTE OF DENTAL SCIENCE 
Address  Department number 3, Department of prosthodontics crown and bridge ground floor, KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar Belgaum KARNATAKA 590010 Belgaum
K.L.E.V.K.INSTITUE OF DENTAL SCIENCE,
Belgaum
KARNATAKA
590010
India 
Phone  07020049533  
Fax    
Email  prernakalyani95@gmail.com  
 
Source of Monetary or Material Support  
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, 590010, Karnataka, India 
 
Primary Sponsor  
Name  prerna kalyani 
Address  Department number 3, Department of prosthodontic crown and bridge ground floor. Belgaum KARNATAKA 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
prerna kalyani  Department number 3, Department of prosthodontic crown and bridge ground floor. Belgaum KARNATAKA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
PRERNA KALYANI  KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar   Department number 3, Department of prosthodontoc crown and bridge, second floor. Belgaum KARNATAKA
Belgaum
KARNATAKA 
7020049533

prernakalyani95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  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 
Comparator Agent  conventional workflow  accuracy of implant crown 
Intervention  digital workflow  accuracy of implant crown 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patient age between 21-60 years.
2 Patient in need of an implant supported crown in the molar region who have successfully completed stage 1 of implant treatment.
3 Absence of any medical condition.
4 Absence of any periodontal disease.
5 Opposing dentition should be natural teeth or fixed definitive restoration on teeth or implant.
6 Presence of at least one intact adjacent tooth or fixed definitive restoration on teeth or implant.
7 Patients who are willing to participate in the present study and willing sign the informed consent form.
 
 
ExclusionCriteria 
Details  1 Participants with inadequate oral hygiene.
2 Implants showing signs of peri-implantitis.
3 Presence of periapical radiolucency at adjacent teeth.
4 Periodontitis or persistent intraoral infections.
5 Absence of adjacent teeth.
6 Untreated mucosal diseases.
7 Presence of parafunctional habits
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• To evaluate marginal and internal fit of single posterior implant retained crown fabricated using conventional and digital impression workflow  • baseline 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare marginal & internal fit of single posterior implant retained crown fabricated using conventional & digital impression workflow.  baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/09/2024 
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="0"
Months="5"
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  
Implant-supported fixed dental prostheses have become a well-accepted treatment option with acceptable success rates for partially edentulous patients. This success can only be achieved with a precise fit of the implant supported restoration, which is critical to the long-term success of any dental restoration. The gap between the implant abutment and the restoration allows bacteria to adhere, causing inflammatory reaction in the peri implant soft tissues and biologic complications of the surrounding tissues.

Conventional fixture-level implant impression techniques in combination with master casts and porcelain fused to metal (PFM) crowns still represent the gold standard in the manufacturing process of fixed implant-supported restorations. However, it is often associated with long time-consuming appointment, complex technique sensitive fabrication steps using expensive equipment, materials, as well as patient related hindrances like suffocation hazard, gagging and taste irritation during the impression taking procedures. An alternative to the well-established conventional impression technique is the next gen digital approach. The clinical patient situation is virtually registered with a contact-free transfer using an intraoral optical scanner (IOS) system.

With regard to accuracy, clinical and in vitro studies have reported variability in results when comparing digital scanning with conventional impression procedures for tooth supported fixed partial dentures. Additionally, the accuracy of digital scanning has been reported to depend on the scanning protocol, operator experience and training, type of arch scans, and use of a reflective agent.

Although many in vitro studies have been conducted to evaluate marginal and internal fit of implant supported restorations, very few in vivo studies have been carried out to evaluate the same.

So, the objective of this in vivo study is to evaluate and compare marginal and internal fit of implant retained prostheses fabricated using conventional and digital workflow.

 

 
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