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CTRI Number  CTRI/2024/07/071647 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Ascorbic acid on postendodontic pain. 
Scientific Title of Study   Effect of Ascorbic acid on occurrence and severity of post endodontic pain following root canal treatment on teeth with irreversible pulpitis. A triple-blind randomized placebo-controlled 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 Shahnaz 
Designation  Assistant Professor 
Affiliation  Faculty Of Dentistry, Jamia Millia Islamia 
Address  Room No. 309, Faculty of Dentistry, JMI,
Jamia Nagar, New Delhi
New Delhi
DELHI
110025
India 
Phone  7006577811  
Fax    
Email  shahnaz@jmi.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shahnaz 
Designation  Assistant Professor 
Affiliation  Faculty Of Dentistry, Jamia Millia Islamia  
Address  ROOM NO. 309, Faculty of Dentistry, JMI
Jamia Nagar, New Delhi,
New Delhi
DELHI
110025
India 
Phone  7006577811  
Fax    
Email  shahnaz@jmi.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shahnaz 
Designation  Assistant Professor 
Affiliation  Faculty of Dentistry, Jamia Millia Islamia 
Address  Room No. 309, Faculty of Dentistry, JMI
Jamia Nagar, New Delhi
New Delhi
DELHI
110025
India 
Phone  7006577811  
Fax    
Email  shahnaz@jmi.ac.in  
 
Source of Monetary or Material Support  
Faculty of Dentistry, JMI, New Delhi. Delhi.110025 
 
Primary Sponsor  
Name  Dr Shahnaz 
Address  Room No. 309, Faculty of Dentistry, JMI, NEW DELHI.110025 
Type of Sponsor  Other [PRIMARY INVESTIGATOR] 
 
Details of Secondary Sponsor  
Name  Address 
faculty of dentistry  jamia nagar new delhi 
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 Shahnaz  FACULTY OF DENTISTRY, JAMIA MILLIA ISLAMIA  Room No. 313, Department of Conservative Dentistry and Endodontics, Jamia Nagar, New Delhi.
New Delhi
DELHI 
7006577811

shahnaz@jmi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INTERNAL RESEARCH REVIEW 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  ASCORBIC ACID OR VITAMIN C 500mg   It will be given to the patients orally, one hour preoperatively. 
Comparator Agent  PLACEBO CONTROL GROUP  A placebo multivitamin tab will be given orally, one hour preoperatively, to the patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy patients having a tooth with symptomatic irreversible pulpitis and normal periapical radiographic appearance. 
 
ExclusionCriteria 
Details  Presence of systemic disorders, a sensitivity to lidocaine with 1:80,000 epinephrine or a history of gastrointestinal ulcers, lactation, pregnancy, using any type of analgesic medication in the preceding 12 hours before the treatment, having a tooth not suitable for restoration, and having a full crown 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Success of preoperative ascorbic acid in reducing post-endodontic pain post-operatively after endodontic treatment.  4hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the effects of ascorbic acid & placebo on post-endodontic pain reduction after endodontic treatment.   4 hrs 8 hrs 12 hrs 24 hrs & 48 hrs 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 4 
Date of First Enrollment (India)   15/08/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Complete pain alleviation is a necessary precondition for endodontic therapy to be successful. Although microorganisms are commonly thought to be the primary cause of postoperative pain, pulpal or peri-radicular tissues may also be injured mechanically or chemically. Prostaglandins, leukotrienes, bradykinin, and serotonin are inflammatory mediators that activate sensitive nociceptors and cause postoperative endodontic pain. This can result in both peripheral and central mechanisms of hyperalgesia. Non-steroid anti-inflammatory medicines (NSAIDs), which are often used postoperative analgesics, have been linked to undesirable side effects, such as respiratory suppression, as well as other relatively mild issues, including nausea or vomiting. The L-enantiomer of ascorbate, or ascorbic acid, is commonly referred to as vitamin C and is a water-soluble antioxidant that may be found in a wide range of fruits and vegetables. There aren’t many research currently available assessing ascorbic acid’s impact on post endodontic pain. Therefore, the goal of this study is to clarify how well ascorbic acid works in situations with irreversible pulpitis to reduce immediate postoperative pain after root canal therapy.

Aim: evaluate the effect of ascorbic acid preoperatively on post endodontic pain reduction following endodontic treatment in irreversible pulpitis cases.

 Objectives:

1)      Evaluate the effect of ascorbic acid on reduction of post endodontic pain at 4hrs, 8 hrs. 12 hrs, 24 hrs., and 48 hrs. Postoperatively in cases with preoperative irreversible pulpitis.

2)      Compare the effect of ascorbic acid with placebo in reduction of post endodontic pain.

Material and methods: This study will be a prospective parallel arm randomized triple -blind placebo-controlled trial. The study will be carried out in the Department Of Conservative Dentistry And Endodontics, Faculty of Dentistry, and Jamia Millia Islamia. 60 patients (30 per group) with symptomatic irreversible pulpitis will be recruited for the study. The patients will be divided into two Groups. Group 1 will be given 500 mg ascorbic acid, one hour before the local anaesthesia. Group 2 patients will be given placebo multivitamin tablet one hour before local anaesthesia... Each patient will record their pain score on a heft parker visual analog scale before taking the medicine, at 4hrs, 8 hrs, 12 hrs, 24 hrs, and 48 hrs postoperatively.

 
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