| CTRI Number |
CTRI/2024/08/072104 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of new intracanal dressing to reduce pain during root canal treatment |
|
Scientific Title of Study
|
Analgesic Effect Of Single Antibiotic Paste Nitrofurantoin as an Intracanal medicament– A Randomized 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 Khandelwal Shruti Sunilkumar |
| Designation |
Post Graduate Student, Department of Conservative Dentistry and Endodontics |
| Affiliation |
Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon 491441 |
| Address |
Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9765369423 |
| Fax |
|
| Email |
khandelwalshruti968@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khandelwal Shruti Sunilkumar |
| Designation |
Post Graduate Student, Department of Conservative Dentistry and Endodontics |
| Affiliation |
Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh 491441 |
| Address |
Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9765369423 |
| Fax |
|
| Email |
khandelwalshruti968@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Nair |
| Designation |
Head of the Department of Conservative Dentistry and Endodontics |
| Affiliation |
Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh 491441 |
| Address |
Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9630145664 |
| Fax |
|
| Email |
rashmi.a.nair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh, India 491441 |
|
|
Primary Sponsor
|
| Name |
Dr Khandelwal Shruti Sunilkumar |
| Address |
Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh 491441 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Khandelwal Shruti Sunilkumar |
Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh |
Room No.-5, Department of Conservative Dentistry and Endodontics,Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh 491441
Rajnandgaon
CHHATTISGARH |
9765369423
khandelwalshruti968@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Chhattisgarh Dental College and Research Institute,Sundra, Rajnandgaon,Chhattisgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium Hydroxide |
premixed calcium hydroxide paste will be placed for 2 weeks |
| Intervention |
Modified Triple antibiotic paste |
Powdered Clindamycin, Metronidazole, Ciprofloxacin in 1:1:1 ratio mixed with normal saline in 3:1 ratio will be placed for 2 weeks |
| Intervention |
Nitrofurantoin |
25mg of pulverised nitrofurantoin powder will be mixed with 1ml of normal saline will be placed for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic Apical Periodontitis in Single-rooted Maxillary/Mandibular teeth. Teeth in which lesion involving pulp, loss of lamina dura, and widening of PDL space. |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases, self-reported pregnancy, patients with multiple drug allergies, adverse reaction reported to any dental material,patients who have taken analgesics/anti-inflammatory drugs within the last 24 hours
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of Nitrofurantoin as an intracanal medicament to reduce interappointment pain
To evaluate the effectiveness of modified triple antibiotic paste as an intracanal medicament to reduce interappointment pain
To evaluate the effectiveness of calcium hydroxide as an intracanal medicament to reduce interappointment pain
|
The level of pain postoperatively is calculated at 4,12,24 and 48 hours using Numerical pain scale chart |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the recorded data, i.e., the efficacy of Nitrofurantoin, Modified Triple antibiotic paste and Calcium hydroxide as an intracanal medicament in reducing interappointment pain |
The level of pain postoperatively is calculated at 4,12,24 and 48 hours using Numerical pain scale chart |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2024 |
| Date of Study Completion (India) |
17/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
To evaluate the
effectiveness of Nitrofurantoin as an intracanal medicament to reduce
interappointment pain during endodontic treatment.
To
evaluate the effectiveness of modified triple antibiotic paste as an intracanal
medicament to reduce
interappointment pain during endodontic treatment.
To
evaluate the effectiveness of calcium hydroxide as an intracanal medicament to reduce
interappointment pain during endodontic treatment.
|