| CTRI Number |
CTRI/2021/03/032269 [Registered on: 24/03/2021] Trial Registered Prospectively |
| Last Modified On: |
22/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia
Diagnostic
Preventive
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Intracanal Medicaments in Incidence of Post-Operative Endodontic Pain |
|
Scientific Title of Study
|
Comparative Evaluation of Post-Operative Endodontic Pain Using Various Intracanal Medicaments After Instrumentation with Rotary Single-File System-In Vivo Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhilasha Bhawalkar |
| Designation |
B.D.S.(M.D.S. 3RD YR P.G.) |
| Affiliation |
Dr. D.Y.Patil Dental College and Hospital,Pimpri,Pune |
| Address |
Dr. D.Y.Patil Dental College and Hospital, Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9860998482 |
| Fax |
|
| Email |
abhilasha_bhawalkar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjyot Mulay |
| Designation |
M.D.S.,Professor and Guide |
| Affiliation |
Dr. D.Y.Patil Dental College and Hospital,Pimpri,Pune |
| Address |
Dr. D.Y.Patil Dental College and Hospital, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822036048 |
| Fax |
|
| Email |
sanjyot.mulay@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhilasha Bhawalkar |
| Designation |
B.D.S.(M.D.S. 3RD YR P.G.) |
| Affiliation |
Dr. D.Y.Patil Dental College and Hospital,Pimpri,Pune |
| Address |
Dr.D.Y.Patil Dental College and Hospital, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9860998482 |
| Fax |
|
| Email |
abhilasha_bhawalkar@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y.Patil Dental College and Hospital,Dept of Conservative Dentistry and Endodontics |
|
|
Primary Sponsor
|
| Name |
Dr Abhilasha Bhawalkar |
| Address |
5/141, Niraj Apartments,Nehru Nagar,Pimpri,Pune-18 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Abhilasha Bhawalkar |
Dr. D.Y.Patil Dental College and Hospital,Pune |
Dr.D.Y.Patil Dental College and Hospital,Dept of Conservative Dentistry and Endodontics,Dr.D.Y.Patil Vidyapeeth,Pimpri,pune-18
Pune
MAHARASHTRA |
09860998482
abhilasha_bhawalkar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y.Patil Vidyapeeth,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, , (2) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.9% Normal Saline |
Fresh solution, 5ml inside the canal |
| Comparator Agent |
10perc Metronidazole |
10% gel preparation, 2ml, for seven days inside the canal |
| Comparator Agent |
2%Chitosan |
Nanoparticles diluted in saline,2ml, for seven days inside the canal |
| Comparator Agent |
Calcium hydroxide and 2% Chlorhexidine gel
|
Gels and sloutions will be prepared in the above concentrations in the pharmacy college of the institute, 2ml for seven days inside the root canal |
| Comparator Agent |
Septilin |
Gel preparation, 2ml aqueous extract for seven days inside the canal |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Vital and non-vital Mandibular 1st and 2nd molars
2. Presence of occlusal caries
3. Symptomatic patients with moderate pain
4. Radiographically verified Apical Periodontitis with widening of the Periodontol Ligament Space
5. Periapical lesion less than 2mm
6. Fully formed root apices
7. Age 25-45 yrs
8. Systemically Healthy Patients
|
|
| ExclusionCriteria |
| Details |
1. Large periapical(>2mm) lesion seen radiographically
2. Roots with apical patency equal to or more than #25
3. Teeth with Proximal Caries
4. Pulpal involvements with any other tooth from that side
5. Roots showing internal and external resorption
6. Cracked roots
7. Calcified root
8. Root Curvatures >20o.
9. Developmental anomalies
10. Radix Entomolaris/Paramolaris
11. Severe attrition
12. Traumatized teeth
13. Opposing prosthesis
14. Teeth with sinus tract or abscess
15. Teeth with Periodontal Pockets
16. Patients having any systemic condition eg.Diabetes,Hypertension,Hyperthyroidism,Hypothyroidism etc,influencing the outcome of root canal treatment
17. Patients on any oral medication or having consumed any medication(i.e.anti-inflammatory-analgesic,antibiotic) within 48 hrs of treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is pain reduction |
6,12,24,48,72 hrs, one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No occurance of pain and no need for systemic medication |
6,12,24,48,72 hrs and one week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [abhilasha_bhawalkar@hotmail.com].
- For how long will this data be available start date provided 01-04-2021 and end date provided 13-03-2021?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This will be a study on 50 patients showing mild to moderate pain symptoms who will undergo root canal treatment .After doing the access cavity preparation,complete instrumentation with OneCurve(Micromega) rotary file, intracanal medicaments like Calcium hydroxide and 2% Chlorhexidine mixture, Septilin,Chitosan,10%Metronidazole and no medicament(Normal Saline) as divided equally(n=5) will be used and patients will be asked for post-operative pain at 6,12,24,36,72 and one week time phrame. Final step of Root Canal will be done after 7 days. |