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CTRI Number  CTRI/2025/07/089909 [Registered on: 01/07/2025] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessing the efficacy of a novel pulpotomy medicament for treating irreversible pulpitis: A clinical investigation 
Scientific Title of Study   Evaluating the efficiency of a novel pulpotomy medicament in treating mature permanent teeth with irreversible pulpitis: An in vivo study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B Suvetha 
Designation  Post graduate 
Affiliation  RVS dental college and hospital, Department of conservative dentistry and endodontics 
Address  322/9 Kanjikovil road Opposite to thainagar Karumandisellipalayam Perundurai

Erode
TAMIL NADU
638052
India 
Phone  7603999939  
Fax    
Email  balusuvetha1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. VINOO SUBRAMANIAM.RAMACHANDRAN 
Designation  Professor 
Affiliation  RVS dental college and hospital, Department of conservative dentistry and endodontics 
Address  RVS dental college and hospital, Kumaran kottam campus, Kannampalayam, Sulur, Coimbatore

Coimbatore
TAMIL NADU
641402
India 
Phone  9841242628  
Fax    
Email  vinoomds@yahoo.com  
 
Details of Contact Person
Public Query  
Name  B Suvetha 
Designation  Post graduate 
Affiliation  RVS dental college and hospital, Department of conservative dentistry and endodontics 
Address  322/9 Kanjikovil road Opposite to thainagar Karumandisellipalayam Perundurai

Erode
TAMIL NADU
638052
India 
Phone  7603999939  
Fax    
Email  balusuvetha1998@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTIC,RVS DENTAL COLLEGE AND HOSPITAL,KUMARAN KOTTAM CAMPUS, KANNAMPALAYAM, SULUR, COIMBATORE - 641402  
 
Primary Sponsor  
Name  RVS DENTAL COLLEGE AND HOSPITAL  
Address  RVS Dental college and hospital Kumaran kottam campus Kannampalayam Sulur Coimbatore - 641402 Tamilnadu, India 
Type of Sponsor  Private hospital/clinic 
 
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 SUVETHA B  RVS dental college and hospital, Department of conservative dentistry and endodontics.  Department of conservative dentistry and endodontics, Room number: 7B
Coimbatore
TAMIL NADU 		 7603999939

balusuvetha1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mineral Trioxide Aggregate (MTA)   Mineral Trioxide aggregate (MTA Angelus)powder is mixed with distilled water and formed into a thick paste like consistency and is placed directly over the pulp and sealed with RMGIC and permanent restoration is placed 
Intervention  Simvastatin  Simvastatin in powder form is mixed with distilled water and formed into a thick paste like consistency and placed over the pulp and is covered with MTA. RMGIC is placed over set MTA and permanent restoration is done 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patients between the age of 16 to 40 years with no medical history.
2. Mature permanent teeth with diagnosis of irreversible pulpitis.
3. Teeth exhibiting positive response to cold and electric pulp test.
4. Restorable teeth with normal probing pocket depth and mobility within normal limits.
5. Pre-operative pain scores less than or equal to 6.
6. Final selection will be made intra operatively, only if there is fresh vital bleeding from the canals and only if hemostasis is achieved within 10 minutes of coronal pulp removal.
 
 
ExclusionCriteria 
Details  1.Patients under systemic conditions/allergy/medication
2.Previously restored teeth
3.Fractured teeth
4.Non-restorable teeth
5.Teeth with negative response to sensibility test.
6.Teeth with clinical signs and symptoms of pulp necrosis.
7.Teeth exhibiting tenderness on percussion and palpation
8.Presence of swelling or sinus tract or fistula
9.Teeth with pathological mobility
Radiographic exclusion including pdl widening, periapical pathology,internal and external resorption,pulp calcification,furcation defects,inter radicular and peri radicular bone destruction
Intraoperative exclusion includes no pulp exposure after caries excavation, uncontrollable bleeding of more than 10 minutes and absence of bleeding after pulp exposure. 
 
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 and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-operative pain scores
 		 24 hours, 48 hours, 1 week, 6 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical criteria including post operative pain scores, positive response to electric pulp test,no recurrent caries,no tenderness on percussion and palpation,normal mobility limits and probing depth,no abscess or fistula tion, normal surrounding soft tissues

Radiographic criteria includes no pdl widening,no new periapical lesion,no resorption or calcification. 		 6 months and 12 months 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   17/07/2025 
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 - 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 - Informed Consent Form

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [balusuvetha1998@gmail.com].

  6. For how long will this data be available start date provided 17-07-2026 and end date provided 20-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study will be performed to compare and evaluate the clinical and radiographic effectiveness of simvastatin as a pulpotomy medicament in comparison with MTA for managing mature permanent teeth with irreversible pulpitis. Thirty patients with signs and symptoms of irreversible pulpitis will be randomly assigned to two groups: Group I: MTA pulpotomy, Group II: Simvastatin pulpotomy. Informed consent will be obtained from all the patients selected for the study. Pre-operative pain scores will be recorded using a visual analog scale. The entire procedure will be carried out adhering to strict aseptic techniques and under magnification. Local anesthesia will be administered using 2% lignocaine containing 1:80,000 epinephrine. Following rubber dam isolation and cavity disinfection, complete caries excavation and deroofing will be performed. The coronal pulp was amputated to the level of the canal orifice using a large round bur. Following full pulpotomy, hemostasis will be achieved by applying a sterile cotton pellet moistened with 5% NaOCl for up to 10 minutes under light pressure and respective pulpotomy medicament will be placed. In the experimental group, subsequent to the placement of pulpotomy medicament, a layer of MTA will be placed over simvastatin. In both the groups, RMGIC base will be placed and the final restoration will be completed with composite resin. An immediate post-operative radiograph will be taken. Patients will be instructed to record their post-operative pain scores on the provided Visual Analogue Scale, marking the level that best described their pain at 24 hours, 48 hours and 1 week. Patients experiencing pain will be prescribed analgesics. Follow-ups will be scheduled at 6 months and 12 months post-operatively. During these follow-ups, the success of the treatment will be evaluated based on clinical criteria including post-operative pain scores, vitality, presence or absence of swelling, sinus tract formation, tooth mobility and normal functionality of the tooth, along with radiographic criteria such as the presence or absence of periapical pathology, calcification, and resorption. If Simvastatin is proven to be as effective as MTA, it would be beneficial due to its cost-effectiveness. 
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