| 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
|
|
|
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. |