| 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
|
|
|
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
|
|
|
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. |