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CTRI Number  CTRI/2024/10/075900 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   To study how the caries location affects the success of Vital Pulp Therapy 
Scientific Title of Study   Impact of caries initiation site on the efficacy of Vital Pulp Therapy in Mature Mandibular Molars with Symptomatic Irreversible Pulpitis :A Prospective 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  Dr Prabha Shristha 
Designation  Junior Resident( Conservative Dentistry & Endodontics) 
Affiliation  Faculty of Dental Sciences, King Georges Medical University 
Address  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, King Georges Medical University

Lucknow
UTTAR PRADESH
226003
India 
Phone  7906643080  
Fax    
Email  shristha.prabha1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijay Kumar Shakya 
Designation  Professor (J.G) Conservative Dentistry & Endodontics  
Affiliation  Faculty of Dentistry & Endodontics, King Georges Medical University 
Address  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, King Georges Medical University

Lucknow
UTTAR PRADESH
226003
India 
Phone  9140230667  
Fax    
Email  dr.vijay.shakya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rakesh Kumar Yadav 
Designation  Professor (Conservative Dentistry & Endodontics) 
Affiliation  Faculty of Dental Endodontics, King Georges Medical University 
Address  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, King Georges Medical University

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415281156  
Fax    
Email  rakeshanita10@yahoo.in  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry & Endodontics , King Georges Medical University Lucknow, Uttar Pradesh, India Pin code-226003 
 
Primary Sponsor  
Name  Not Applicable 
Address  Not Applicable  
Type of Sponsor  Other [Not Applicable] 
 
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 Prabha Shristha   Faculty of Dental sciences, King Georges Medical University   Old Dental Building 1st Floor Department of Conservative Dentistry & Endodontics
Lucknow
UTTAR PRADESH 
7906643080

shristha.prabha1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University , Institutional Ethics 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 
Intervention  Vital Pulp Therapy by using Calcium Silicate based Cements as pulp capping agents  Vital Pulp Therapy by using calcium silicate-based cements as pulp capping agents is done in mature mandibular first molar with symptomatic irreversible pulpitis in both groups which are - mesial caries initiation site and distal caries initiation site.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Healthy patients with No Relevant History & who
will give the written consent.
2. Permanent molar with deep caries and subsequent
pulp exposure.
3. Diagnosis of Symptomatic Irreversible Pulpitis.
4. Soft tissue around the tooth is normal with no
swelling or sinus tract.
5. Hemostasis should be achieved after pulpotomy.  
 
ExclusionCriteria 
Details  1. Patient who denied to take part in the study.
2. Patients with systemic disease that interferes.
with pulp healing.
3. No hemostasis is achieved in 5-10min of
pulpotomy.
4. Radiographic evidence of internal or external
resorption, inter-radicular bone loss, or
periapical pathology.
5. The tooth is non restorable.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical evaluation of the impact of caries initiation site on the vital pulp therapy  1 month and after that at 3 months interval 
 
Secondary Outcome  
Outcome  TimePoints 
Radiographical evaluation of the impact of caries initiation site on the efficacy of vital pulp therapy  1 month and after that at 3 months interval 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   31/10/2024 
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="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  

Dental caries is a significant global problem affecting people of all ages, necessitating intervention aimed at minimizing detrimental effects on the remaining dental pulp. Caries is a biofilm-induced disease, driven by a supply of fermentable carbohydrates. The resulting ecological shift creates an acidogenic, cariogenic niche, which breaks down dental hard tissue to form a cavity. Clinically, deep carious lesions can lead to pain, sensitivity, and the risk of pulp infection. If left untreated, caries will advance through dentine initiating pulpitis and necrosis; however, if conservatively managed, pulpal recovery occurs even in deep carious lesions. Conventionally Root canal treatment (RCT) has been considered the standard for the management of teeth with carious pulp exposure, particularly in mature teeth presenting with symptomatic irreversible pulpitis. The field of endodontics is presently undergoing a shift when it comes to the management of deep caries and exposed pulp with its focus gradually shifting towards minimally invasive biological procedures also termed Vital Pulp Therapy (VPT). 

Histological studies have shown that infection is often limited to the coronal chamber of the root canal system of the cariously exposed pulp, mechanical or traumatic vital pulp exposure. And, if the carious portion is removed and the infected pulp tissue is amputated, remaining healthy tissue can be repaired.  Vital pulp therapy procedures are not only technically simpler but more economical, over conventional RCT. Biological characteristics of hydrophilic Calcium Silicate based Cements (CSCs) have enabled consistent successful treatment modalities for teeth with carious pulp exposure and symptoms indicative of irreversible pulpitis.

Furthermore, VPT became a recognized treatment modality by the European Society of Endodontology (ESE) and the American Association of Endodontics (AAE) by virtue of its high success rates.

Nevertheless, the age of the patient seems to plays only a minor role in treatment success.  The same applies to factors such as the sex of the patient, tooth position (posterior or anterior), and the size or location of the pulp exposure. As we are not very clear about the impact of the caries initiation site. So through this study, we are going to evaluate the impact of caries initiation site on the efficacy of Vital Pulp Therapy.

AIM AND OBJECTIVE:

      Impact of Caries initiation site on the efficacy of Vital Pulp Therapy in Symptomatic Irreversible Pulpitis a Clinical and radiographical evaluation.

M MATERIAL AND METHOD:

The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Faculty of Dental Science, King George’s Medical University, Lucknow.

         The study will be conducted only after getting clearance from the Institutional Ethical Committee and registration in CTRI.

       The study aims to include suitable number of patients with symptomatic irreversible pulpitis in mature mandibular molar teeth, who will give a written consent and adhere in the inclusion criteria of Vital Pulp Therapy will be categorized in different groups based on  caries initiation site.

Vital Pulp Therapy is done following the guidelines of European Society of Endodontics (ESE). Clinical and radiographical evaluation will be done to evaluate the efficacy of Vital Pulp Therapy at required intervals.

             Data obtained will be statistically analyzed. Any changes deemed in the interest to the study will be done accordingly.

 
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