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CTRI Number  CTRI/2024/10/074951 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A Clinical trial to Compare the quality of two restorative materials Smart Dentin Replacement plus and Tetric N Ceram using two filling technique 
Scientific Title of Study   Assessing the quality of restoration using Smart Dentin Replacement+ and Tetric N Ceram done in Class I pits and fissure caries using Bulk fill and Incremental Technique-An In vivo Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
mohit12346  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohit kumar jyotiyana 
Designation  Postgraduate student 
Affiliation  Mahatma Gandhi Dental College and Hospital 
Address  Ricco Industrial Area, Sitapura, Jaipur, Ramchandpura, Rajasthan 303905
2090/29 Laxmi Bai Nagar Dhola Bhata ajmer 305001
Jaipur
RAJASTHAN
303905
India 
Phone  75978152588  
Fax    
Email  mohitk770@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MOHIT KUMAR JYOTIYANA 
Designation  Post Graduate Student 
Affiliation  Mahatma gandhi dental college and hospital jaipur 
Address  Ricco Industrial Area, Sitapura, Jaipur, Ramchandpura, Rajasthan 303905

Jaipur
RAJASTHAN
302022
India 
Phone  7597815288  
Fax    
Email  mohitk770@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MOHIT KUMAR JYOTIYANA 
Designation   
Affiliation  Mahatma gandhi dental college and hospital jaipur 
Address  Ricco Industrial Area, Sitapura, Jaipur, Ramchandpura, Rajasthan 303905

Jaipur
RAJASTHAN
302022
India 
Phone  7597815288  
Fax    
Email  mohitk770@gmail.com  
 
Source of Monetary or Material Support  
Dr Mohit kumar jyotiyana 
 
Primary Sponsor  
Name  Mahatma Gandhi Dental College and hospital jaipur 
Address  Mahatma Gandhi Dental College and hospital jaipur Sitapura JAIPUR 302022 
Type of Sponsor  Other [Mahatma Gandhi Dental College and hospital jaipur] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Mohit kumar jyotiyana  2090/29 laxmi bai nagar dhola bhata ajmer 305001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMohit Kumar Jyotiyana  Mahatma Gandhi Dental college And Hospital   Department Of Conservative and endodontics Room no 5 Sitapura,Jaipur,302022
Jaipur
RAJASTHAN 
7597815288

mohitk770@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MGDC jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Assessing the quality of restoration using Smart Dentin Replacement plus and Tetric N Ceram done in Class I pits and fissure caries  Assessing the quality of restoration using Smart Dentin Replacement plus and Tetric N Ceram done in Class I pits and fissure caries using Bulk fill and Incremental Technique-An In vivo Study 
Comparator Agent  Smart Dentin Replacement plus and Tetric N Ceram restorative material  Clinical success rate of the above materials is compaired 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  36.00 Year(s)
Gender  Both 
Details  1.Patients in need of restoration of Class I pits and fissure carious lesion.
2.Antagonist and the adjacent tooth should be in contact.
3.Absence of hypersensitivity, without any pulpal and periodontal disease.
4.Patient having DMFT score LESS THAN 1. 
 
ExclusionCriteria 
Details  1.Patients with fewer than 20 teeth, malocclusion.
2.Known allergy to drugs and analgesics.
3.Known allergy to resin-based materials.
4.Pregnancy or breastfeeding.
5.Non vital teeth, abutment teeth for fixed or removable prosthesis
• The adjacent tooth having Full coverage restorations. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the clinical performance of smart dentin replacement (SDR+) flowable bulk fill & Tetric N Ceram composite in Class I pits and fissure cavities with incremental technique and bulk fill technique.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the clinical performance of smart dentin replacement (SDR+) flowable bulk fill & Tetric N Ceram composite in Class I pits and fissure cavities with incremental technique and bulk fill technique.  1 year 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   10/10/2024 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Clinical Study Report

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  PUBLICATION

  6. For how long will this data be available start date provided 01-08-2024 and end date provided 10-02-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Resin-based composite (RBC) stands as the predominant choice for contemporary dental restorations, prized for its superior esthetic qualities and simple application. Nevertheless, it harbors potential complications stemming from inadequate polymerization and the accompanying issue of polymerization shrinkage5.
 
This issue has been addressed through various methods, such as utilizing larger monomers to reduce the quantity of double bonds available for reaction, incorporating inorganic fillers that remain inert during polymerization, minimizing volume shrinkage by adjusting the chemistry or composition of the resin system, and implementing clinical techniques aimed at mitigating the impacts of polymerization shrinkage5.
 
  Achieving sufficient polymerization in composite resin placement requires three crucial characteristics in the light-curing unit: Sufficient light output, the appropriate wavelength range, and the correct exposure time. Other factors influencing the depth of cure include the resin composite (RC) type, its shade and translucency, the thickness of each increment, the distance from the light-curing unit tip, the post-irradiation period, and the size and distribution of filler particles2.
 
  Various methods exist for placing composite resins in cavities. Some researchers advocate for an incremental technique, where the material is applied gradually in layers of 2 mm or less. This method offers several advantages, such as improved light penetration and resin polymerization, reduced cavity configuration factor, diminished cuspal deflection, lower polymerization shrinkage stresses, and enhanced resin adhesion to cavity walls. However, alongside these benefits, there are drawbacks to the incremental approach, including the potential for voids between increments, bonding failures, difficulty in placing material after conservative cavity preparation, and increased procedure time due to the need to place and polymerize each increment. In an attempt to address many of these limitations, several new restorative materials marketed as "bulk-fill" composites have emerged 2.
 
Recent studies indicate that polymerization stress is significantly reduced (3-4 times lower) when using a 4-mm layer of SDR during polymerization. SDR technology relies on a unique chemical composition in its organic phase, incorporating a polymerization modulator. One of its components, urethane Di methacrylate resin, acts as a monomer controlling the polymerization process, initiating a chemical "soft start." This leads to the formation of a polymerization network in a more linear and gradual manner, effectively limiting shrinkage stress. Additionally, SDR exhibits comparable physical properties to traditional composites, including susceptibility, surface texture, gloss, and color. This similarity makes it particularly advantageous for restoring defects on hard tissue contact surfaces. The foundational material represents a significant advancement in conservative dentistry.
 
The objective of this study was to evaluate, through randomized double blinded comparison, the clinical effectiveness of using flowable resin composite applied in bulk increments of up to 4mm in large and deep pits and fissure cavities. The cavities were filled using SDR, extending 2mm short of the occlusal Cavo surface, and then covered with a nano-hybrid resin composite. The SDR restoration was compared within the same individual to a restoration using only nano-hybrid resin composite, applied and cured using a 2mm layering technique and after that evaluation using dye impregnation method with DOM (Dental Operating Microscope) under 6X magnification for sensitivity and secondary caries with bite wing radiographs within baseline,6month and 12 month follow up. Both the experimental bulk-fill technique and the resin composite-only control were bonded using a one-step self-etching bonding system. The hypothesis under examination was whether bulk-fill restorations would exhibit comparable durability with Incremental fill one of the similar restorations.
 

 
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