| CTRI Number |
CTRI/2025/08/092269 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying nitrofurantoin and silver impregnated nitrofurantoin affecting pain and healing after root canal treatment: A clinical trial |
|
Scientific Title of Study
|
Evaluating Intracanal Medicaments: Nitrofurantoin, Nano-Silver Nitrofurantoin, and Ultracal in Postoperative Pain and Periapical Lesion Management - A Randomized 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 Kalp R Kubadiya |
| Designation |
1st year PG student |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
Department of Conservative Dentistry & Endodontics, Govt Dental College & Hospital Jamnagar, Navagam- Ghed, Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9265461886 |
| Fax |
|
| Email |
kalpkubadia15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leena Jobanputra |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
Department of Conservative Dentistry & Endodontics, Govt Dental College & Hospital Jamnagar, Navagam- Ghed, Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9879503545 |
| Fax |
|
| Email |
lihiren@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leena Jobanputra |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
Department of Conservative Dentistry & Endodontics, Govt Dental College & Hospital Jamnagar, Navagam- Ghed, Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9879503545 |
| Fax |
|
| Email |
lihiren@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital Jamnagar, Pathikashram Main road, Navagam, Jamnagar, Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Dr Kalp R Kubadiya |
| Address |
Department of Conservative Dentistry & Endodontics, Govt Dental College & Hospital Jamnagar, Navagam- Ghed, Jamnagar -361008 |
| 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 Kalp R Kubadiya |
Government Dental College and Hospital Jamnagar |
203,second floor,Department of Conservative Dentistry & Endodontics, Govt Dental College & Hospital Jamnagar, Navagam Ghed, Jamnagar
Jamnagar
GUJARAT |
09265461886
kalpkubadia15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee M.P. Shah Govt Medical College & Guru Gobindsingh Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium hydroxide as an intracanal medicament |
After biomechanical preparation calcium hydroxide is placed as an intracanal (route) medicament |
| Intervention |
Nitrofurantoin as an intracanal medicament |
After biomechanical preparation nitrofurantoin 25mg is placed as an intracanal (route) medicament |
| Intervention |
Nitrofurantoin impregnated silver nanoparticles as an intracanal medicament |
After biomechanical preparation 25mg nitrofurantoin impregnated silver nanoparticles 1:1 ratio is placed as an intracanal (route) medicament |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patients between the age group of 18 – 60 years.
Physically and mentally healthy patients.
Maxillary and mandibular single-rooted teeth.
Clinically negative response or no tenderness on percussion.
No response on cold and EPT pulp sensitivity testing.
Patients Diagnosed with symptomatic apical periodontitis.
Radiographically presence of periapical radiolucency of 2-5 mm size.
Patients who gave consent for treatment and follow-up.
Patients who were ready to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Systemically compromised patients.
Multirooted tooth.
Weeping canal
Positive history of antibiotics and analgesics use within the week before treatment.
Large periapical lesion
Retreatment cases
Patients taking antibiotics or immunosuppressive drugs six months before the study.
Pregnancy or lactation |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of post operative pain and resolution of periapical abscess |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time required for the resolution of the lesion to interpret the effectiveness of the treatment |
1 year |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
02/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Background: After any initiated root canal procedure, chances of pain are present which may last for 2-5 days post the treatment. Also, after effective appropriate root canal procedure, the periapical lesion should resolve over a period of time
Purpose: This randomized clinical trial aims to assess the effectiveness of nitrofurantoin and nitrofurantoin impregnated silver nanoparticles in the reduction of post operative pain and also in resolution of periapical lesion. By comparing outcomes with conventional method, we aim to identify the optimal approach for improving patient comfort and treatment success rate in endodontic practice. |