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CTRI Number  CTRI/2024/11/076881 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 14/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   To Evaluate and Compare One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin clinically using USPHS criteria and after artificial ageing - A Two year Study  
Scientific Title of Study   Comparative evaluation of clinical performance of One shade Universal Composite and Universal Nanohybrid Composite in non carious cervical lesions and after artificial ageing - A two year randomised clinical 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  Pradnya V Bansode Wadikar 
Designation  Prof and Head of Department Conservative Dentistry and Endodontics Chhatrapati Sambhajinagar 
Affiliation  Govt Dental College And Hospital Chhatrapati Sambhajinagar 
Address  Department of Conservative Dentistry and Endodontics Government Dental College and Hospital Chhatrapati Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  8308263792  
Fax    
Email  pradnyawadikar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pradnya V Bansode Wadikar 
Designation  Prof and Head of Department Conservative Dentistry and Endodontics Chhatrapati Sambhajinagar 
Affiliation  Govt Dental College And Hospital Chhatrapati Sambhajinagar 
Address  Department of Conservative Dentistry and Endodontics Government Dental College and Hospital Chhatrapati Sambhajinagar
Dr. Sadashiv Daokar, Dr. Sumanthini M Professor and HOD, CSMSS Dental College and Hospital, Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431001
India 
Phone  8308263792  
Fax    
Email  pradnyawadikar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pradnya V Bansode Wadikar 
Designation  Prof and Head of Department Conservative Dentistry and Endodontics Chhatrapati Sambhajinagar 
Affiliation  Govt Dental College And Hospital Chhatrapati Sambhajinagar 
Address  Department of Conservative Dentistry and Endodontics Government Dental College and Hospital Chhatrapati Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  8308263792  
Fax    
Email  pradnyawadikar@gmail.com  
 
Source of Monetary or Material Support  
Self financed 
 
Primary Sponsor  
Name  Dr Pradnya V Bansode 
Address  Department of Consevative Dentistry and Endodontics Government Dental College and Hospital Chhatrapati Sambhajinagar 
Type of Sponsor  Other [Self financed] 
 
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 
DrPradnya V Bansode Wadikar  Government Dental College and Hospital Chh.Sambhaji nagar  Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Chhatrapati Sambhajinagar.
Aurangabad
MAHARASHTRA 
8308263792

pradnyawadikar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Govt. Dental College & Hospital Aurangabad (Chh.Sambhaji Nagar)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  patients having atleast two noncarioussmall and shallow cervical abrasions with atleast 1mm depth in Maxillary Premolars 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  To evaluate and compare Omnichroma (One shade Universal Composite) and Fusion (Universal Nanohybrid Composite) in-vivo using modified USPHS Criteria and after artificial ageing in vitro at the end of two years.  Long term clinical evaluation between Omnichroma (One shade Universal Composite) and Fusion (Universal Nanohybrid Composite) will be done.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1)patients with atleast two non carious small and shallow cervical abrasions in maxillary premolars.
2)Good Oral Hygiene.
3) Patients willing to participate in the study and co-operate during the study tenure. 
 
ExclusionCriteria 
Details  (a) Poor oral hygiene

(b) Severe or active periodontal disease.

(c) Caries and lack of compliance.

(d) Non vital teeth

(e) Fractured or visibly cracked teeth

(1) Patient will be excluded if the patient withdraws or opts out of study before 12 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparative evaluation of One Shade Universal Composite resin and Universal Nanohybrid composite resin using digital VITA Shade Guide & modified USPHS criterion to evaluate -
1) marginal discoloration
2) marginal integrity
3) surface texture
4) wear
5) postoperative sensitivity
6) recurrent caries
 
Baseline, 6 months, 12 months, 18 months, 24 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Invitro Comparative evaluation of One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin after preparation of 80 resin discs each of both the materials. Shade, surface roughness and microhardness will be evaluated and compared   Thermocycling of composite resin discs will be done to create artificial ageing. Values will be recorded at baseline, 12 months and 24 months. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   24/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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 - NO
Brief Summary
Modification(s)  

This study involves Invivo and Invitro comparative evaluation of One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin. 80 patients of age group 18 years - 35 years having non carious cervical lesions in atleast two maxillary premolars will be selected for the study after obtaining their informed consent in writing. After preparation of standardised class V cavities at the cervical lesions the two composite resins will be used to restore the same using standardised protocol and as per manufacturers instructions. Clinical evaluation One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin will be done using Digital VITA Shade Guide and using the USPHS Criteria to evaluate marginal discolouration, marginal integrity, surface texture, wear, post operative sensitivity and recurrent caries. The findings will be recorded at baseline, 6 months, 12 months, 18 months and 24 months. There will be blinding of the evaluators who will be evaluating the restorations at the said intervals.

  The Invitro part of the study involves preparation of 80 discs each of One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin having 8 mm diameter and 2 mm depth. All the discs will be subjected to artificial ageing by following the thermocycling protocol for 2 years. Evaluation for shade, surface roughness and microhardness will be done at baseline, 12 months and 24 months. The values will be recorded and saved for statistical analysis.

This study is unique as there will be long term clinical evaluation between One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin and also invitro laboratory comparative evaluation of the disc specimens of the said materials will be carried out.

 

 
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