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CTRI Number  CTRI/2025/04/084958 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 06/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of postoperative sensitivity in non-carious cervical lesions restored with composite and cured with 2 curing modes of LED  
Scientific Title of Study   Comparative evaluation of postoperative sensitivity in non-carious cervical lesions restored with composite using step curing vs continuous curing modes of LED: A split-mouth randomised controlled single-blind trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Shah 
Designation  PG STUDENT 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302 3rd floor, Department of Conservative Dentistry and Endodontics Bharati Vidyapeeth Dental College and Hospital, Sector 7 CBD Belapur Navi Mumbai 400614 Mumbai MAHARASHTRA 400614 India

Mumbai
MAHARASHTRA
400614
India 
Phone  7588110013  
Fax    
Email  poojashah222.ps@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Patil 
Designation  Associate professor 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 Mumbai MAHARASHTRA 400614 India

Mumbai
MAHARASHTRA
400614
India 
Phone  09423903812  
Fax    
Email  amithpatil85@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pooja Shah 
Designation  PG STUDENT 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 Mumbai MAHARASHTRA 400614 India

Mumbai
MAHARASHTRA
400614
India 
Phone  07588110013  
Fax    
Email  poojashah222.ps@gmail.com  
 
Source of Monetary or Material Support  
Dr Pooja Shah Room no 302, 3rd floor, Bharati vidyapeeth dental college and hospital, sector 7, CBD belapur, Navi mumbai 400614 
 
Primary Sponsor  
Name  Dr Pooja Shah 
Address  Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614  
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 Pooja Shah  Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai  Room no 302, 3rd floor Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
7588110013

poojashah222.ps@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K031||Abrasion of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  continuous curing  G-aenial Flo will be applied to surface roughened NCCLs and cured with continuous (constant) curing mode of led for 20 seconds 
Intervention  Step curing   G-aenial Flo will be applied to surface roughened NCCLs and cured with step curing (soft start polymerisation) mode of led 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Cooperative, healthy subjects who are willing to participate in the study and sign the consent form.
Selected subjects must be at least 18 years old and of either sex.
Subjects having NCCLs involving enamel and dentin.
Subjects having at least two contra lateral teeth with Non carious cervical lesion.
Vital teeth giving a positive response to cold test.
 
 
ExclusionCriteria 
Details  Subjects unwilling to sign the consent form.
Teeth with carious lesions.
Subjects with teeth having lesions more than 2 mm in depth.
NCCLs extending below the cemento-enamel junction.
Patients using desensitizing agents regularly.
Teeth with spontaneous, severe or continuous pain and existing sensitivity.
Patients with any irreversible pulpal, periodontal and periapical pathology.
Patients having bruxism.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative sensitivity scores  Post operative sensitivity scores at 24 hours, 7 days and 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
None  Not applicable 
 
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)   20/04/2025 
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  

Post-operative sensitivity after composite restoration remains a challenge and in most studies postoperative sensitivity was found to be up to onethird of the study sample· Non carious cervical lesions [NCCL] cause loss of dental hard tissue in the cervical part of the tooth exposing the dentinal tubules to the oral environment. · Thus, when the affected tooth is exposed to heat or stimuli, it results in expansion and contraction of dentinal fluids in the gap formed, which causes fluid movement in the dentinal tubules leading to postoperative sensitivity. · Flowable resins tend to absorb the stresses created during polymerization shrinkage. G-aenial Universal Flow, a flowable resin tends to exhibit lower polymerization shrinkage stress of about 1.3 MPa, which leads to lesser postoperative sensitivity.· It is claimed that soft start polymerization technique reduces polymerization shrinkage sequentially reducing microgaps, microleakage, and postoperative sensitivity. Thus we have undertaken this study comparing postoperative sensitivity using G-aenial Universal Flo with step curing and continuous curing technique in NCCL · Hence this study will highlight if step curing is a better treatment modality than continuous curing in reducing postoperative sensitivity in NCCL, so that a better technique can be adopted in subsequent patients.

 
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