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CTRI Number  CTRI/2020/09/027648 [Registered on: 08/09/2020] Trial Registered Prospectively
Last Modified On: 26/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of cavities filled with preheated composites and ultrasonically plasticized composites  
Scientific Title of Study   ‘Clinical Behaviour Of Composite Resin restoration Plasticized With Different techniques 
Trial Acronym  .. 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Girija S Sajjan 
Designation  HOD and Professor 
Affiliation  Vishnu Dental College 
Address  Department of Conservative Dentistry and Endodontics, Vishnu Dental College
Vishnupur ,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India 
Phone  8179846088  
Fax    
Email  girijaendo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sindhu Dutta 
Designation  Post Graduate 
Affiliation  Vishnu Dental College 
Address  Department of Conservative Dentistry and Endodontics, Vishnu Dental College
Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India 
Phone  7989811611  
Fax    
Email  sindhudutta1995@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sindhu Dutta 
Designation  Post Graduate 
Affiliation  Vishnu Dental College 
Address  Department of Conservative Dentistry and Endodontics, Vishnu Dental College
Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India 
Phone  7989811611  
Fax    
Email  sindhudutta1995@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Vishnu Dental College 
Address  Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari, -534202 
Type of Sponsor  Research institution and hospital 
 
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 
Sindhu Dutta  Vishnu Dental College  Department of Conservative Dentistry and Endodontics, Room no -4 Block III vishnu dental college vishnupur ,bhimavaram Andhrapradesh -534202
West Godavari
ANDHRA PRADESH 
7989811611

sindhudutta1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Preheated composite resin  Composite resin will be peheated for 5 mins at 60 degree celcius and will be placed into the cavities. 
Intervention  Ultrasonically plasticized composite resin  composite resin will be placed into the cavities and will be plasticized using ultrasonic tips for 5 minutes at power level of 7. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patient is older than 18 years and younger than 40 years.
The presence of teeth to be restored in occlusion;
Teeth that were symptomless and vital;
A normal periodontal status;
Medium size cavities size of the isthmus with no more than two thirds of the intercuspal distance and the gingival margin of the cavities above the cementoenamel junction.
A good likelihood of recall availability 
 
ExclusionCriteria 
Details  Xerostomia and bruxism
Absence of adjacent and antagonist teeth
Extremely poor oral hygiene, severe or chronic periodontitis
Adverse medical history
Potential behavioural problems. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Will there be difference in clinical outcome in restorations placed by preheating composite and ultrasonic plasticization of composite.  Baseline and One year 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/09/2020 
Date of Study Completion (India) 05/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
submitted 
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 -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [sindhudutta1995@gmail.com].

  6. For how long will this data be available start date provided 24-06-2021 and end date provided 26-06-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  
Good marginal adaptation is the key for successful composite resin restorations as it can reduce microleakage. In the pursuit of improving the strength of composite resin, more fillers are incorporated. The resulting increased viscosity of the material might lead to compromised adaptation to the cavity. This along with polymerization shrinkage may lead to compromised clinical performance. Hence the reduction in viscosity of these materials may improve the marginal adaptation and clinical performance. Preheating of composite resin reduces viscosity and increases flowability, which facilitates better adaptation to cavity walls. The problem here is once composite is pre-heated; there is a time delay between dispensing it from a syringe, placing it into preparation, and subsequently light polymerizing it. It is estimated that when a composite is heated up to 60 â—¦C and removed from the device, the temperature reduces 50% after 2min and 90% after 5min. The problem associated here is their limited literature on the clinical use of preheated composite. Another recent introduction of sonic fill (kerr corp. USA) combines the attributes of a low viscosity composite and a universal composite. By plasticizing composite with sonic energy, it is possible to fill the cavity and adapt the low viscosity material easily and then compact it while composite changes its consistency until it reaches a higher viscosity. But it is not recommended due to the high cost and unavailability in India. By simulating this concept, it was thought that conventional ultrasonic tips may be used for generating ultrasonic vibrations and possible to alter the consistency of high viscosity material to a consistency that can be compacted and made to adapt to cavity walls.
 
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