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CTRI Number  CTRI/2025/06/089739 [Registered on: 27/06/2025] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparing tooth sensitivity after two types of class II cavity treatments 
Scientific Title of Study   EVALUATION OF POSTOPERATIVE SENSITIVITY AND TREATMENT OUTCOMES IN DEEP CLASS-II CAVITIES RESTORED USING BULK FILL VS RMGIC VENEERED WITH NANOHYBRID COMPOSITE AFTER PARTIAL PULPOTOMY:A RANDOMIZED CLINICAL TRIAL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  URVASHI OMPRAKASH AGRAWAL 
Designation  POST GRADUATE STUDENT 
Affiliation  MANUBHAI PATEL DENTAL COLLEGE & HOSPITAL 
Address  MANUBHAI PATEL DENTAL COLLEGE 1st Floor, Department of Conservative dentistry and Endodontics
Vishwajyoti Ashram Near. Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011
Vadodara
GUJARAT
390020
India 
Phone  7990713065  
Fax    
Email  agrawalurvashi22501@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR.ANKIT ARORA 
Designation  PROFESSOR AT MANUBHAI PATEL DENTAL COLLEGE 
Affiliation  MANUBHAI PATEL DENTAL COLLEGE & HOSPITAL 
Address  MANUBHAI PATEL DENTAL COLLEGE 1st Floor, Department of Conservative dentistry and Endodontics
Vishwajyoti Ashram Near. Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011
Vadodara
GUJARAT
390020
India 
Phone  7990713065  
Fax    
Email  agrawalurvashi22501@gmail.com  
 
Details of Contact Person
Public Query  
Name  URVASHI OMPRAKASH AGRAWAL 
Designation  POST GRADUATE STUDENT 
Affiliation  MANUBHAI PATEL DENTAL COLLEGE & HOSPITAL 
Address  MANUBHAI PATEL DENTAL COLLEGE 1st Floor, Department of Conservative dentistry and Endodontics
Vishwajyoti Ashram Near. Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011
Vadodara
GUJARAT
390020
India 
Phone  7990713065  
Fax    
Email  agrawalurvashi22501@gmail.com  
 
Source of Monetary or Material Support  
URVASHI AGRAWAL MANUBHAI PATEL DENTAL COLLEGE Vishwajyoti Ashram Near. Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011 
 
Primary Sponsor  
Name  URVASHI AGRAWAL 
Address  Vishwajyoti Ashram Near. Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011 
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 
URVASHI AGRAWAL  MANUBHAI PATEL DENTAL COLLEGE 1st floor , Department of conservative dentistry and endodontics  Vishwajyoti Ashram Near. Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011
Vadodara
GUJARAT 		 7990713065

agrawalurvashi22501@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  CLASS II DENTAL CARIES 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  POST OPERATIVE SENSITIVITY IN CLASS II WITH RMGIC  CLASS II WITH BULK FILL COMPOSITE RESIN RESTORATION 
Intervention  POST OPERATIVE SENSITIVITY IN CLASS-II PULPOTOMY   compare the effectiveness of bulk fill composite and light-cured RMGIC veneered with high-strength composite in managing postoperative sensitivity and treatment outcomes in deep class-II cavities with partial pulpotomy 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient aged 14-60years
Permanent molar teeth with closed apex.
Symptoms: range from mild - non- spontaneous pain.
Positive response to pulp sensibility test.
Presence of deep carious lesions on radiograph
Pulp exposure after non selective caries removal.

 
 
ExclusionCriteria 
Details 
-Patients on analgesics, blood thinners.
-Incisors or canines or premolars
- heavily restored or non-restorable teeth.

- Patient has moderate-severe pain

- Negative response to pulp sensibility test

- Pulp not exposed intra-operatively

- Presence of “sound” dentine over pulp

- Pulp necrosis evident on after caries removal

-Pulpal hemorrhage could not be arrested

- Pregnant women
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative sensitivity assessment will be done by Heft-Parker visual analogue scale (VAS).   Post operative sensitivity assessment will be done at 24 HOURS,7 DAYS,1 MONTHS,3 MONTHS AND 6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Outcome of Radiographic success will be classified using Orstavik Periapical Index (PAI)  3 months and 6 months 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   05/07/2025 
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="1"
Months="0"
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   This randomized clinical trial will aim to compare the effectiveness of bulk fill composite and light-cured resin-modified glass ionomer cement (RMGIC) veneered with nanohybrid composite in managing postoperative sensitivity and treatment outcomes in deep Class II cavities treated with partial pulpotomy. A total of 74 patients aged 14–60 years with mild to moderate pulpitis and carious exposures will undergo partial pulpotomy using MTA putty, followed by restoration with either bulk fill or RMGIC layered with nanohybrid composite. Postoperative sensitivity will be assessed using the Heft-Parker Visual Analogue Scale (VAS) at 24 hours, 7 days, 1 month, 3 months, and 6 months, while clinical and radiographic evaluations will be conducted to determine treatment success. The study will help identify which restorative approach provides better postoperative comfort and long-term clinical outcomes in vital pulp therapy. 
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