| CTRI Number |
CTRI/2024/07/070000 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Terminalia chebula as intra canal medicament in Endodontic Retreatment cases
|
|
Scientific Title of Study
|
Evaluation of Antimicrobial Effectiveness Of Terminalia Chebula Fruit Extract As An Intracanal Medicament in Endodontic Retreatment cases
-A Randomised 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 Seema Dixit |
| Designation |
Professor, Dept of Conservative Dentistrt and Endodontics |
| Affiliation |
Seema Dental College and Hospital, rishikesh |
| Address |
Room No.5, Department of Conservative Dentistry and Endodontics, Seema Dental College, Veerbhadra Road Rishikesh,
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9818696704 |
| Fax |
|
| Email |
seemadixit247@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Grover |
| Designation |
Professor |
| Affiliation |
Seema Dental College and Hospital Rishikesh |
| Address |
Room No. 5 ,Department of Conservative dentistry and Endodontics,Seema Dental College, Veerbhadra Road Rishikesh,
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8477981601 |
| Fax |
|
| Email |
drgroversheetal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh Dixit |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Dentistry, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9899818242 |
| Fax |
|
| Email |
dixitdrashutosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Botanic Healthcare
Secunderabad Telangana |
|
|
Primary Sponsor
|
| Name |
Seema Dental College and Hospital Rishikesh |
| Address |
SEEMA DENTAL COLLEGE and hospital, Veerbhadra RISHIKESH 249203 |
| Type of Sponsor |
Other [Dental College andHospital] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ASHUTOSH DIXIT |
AIIMS RISHIKESH |
Department Of Dentistry AIIMS RISHIKESH VEERBHADRA ROAD, RISHIKESH 249203
Dehradun
UTTARANCHAL |
9899818242
dixitdrashutosh@gmail.com |
| DR SEEMA DIXIT |
SEEMA DENTAL COLLEGE AND HOSPITAL |
Room No. 5 Department of Conservative Dentistry & Endodontics Seema Dental College and Hospital Veerbhadra VPO PAshulok RISHIKESH 249203
Dehradun
UTTARANCHAL |
9818696704
seemadixit247@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethical Committee Seema Dental College |
Approved |
| EthicalCommitteeSeemaDentalCollege |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K045||Chronic apical periodontitis. Ayurveda Condition: DANTAMULAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | svaBAvaH, सà¥à¤µà¤à¤¾à¤µà¤ƒ | (Procedure Reference: ENDODONTIC RETREATMENT, Procedure details: Removal of GP that will be collected
and sent for culture
After placing ICM for 2 weeks the canals will be flushed copiously with saline, absorbent paper points will be used to collect culture sample
The pre and post samples will be compared
)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Persistent Periodontitis after root canal treatment.
Cases of Endodontic failure needing retreatment.
Previously Endodontically treated teeth with radiographic evidence of periapical lesions
|
|
| ExclusionCriteria |
| Details |
Previously Endodontic treated teeth with vertical root fracture
Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
reduced microbial count relieving the patient of symptoms
improved survival rate of the tooth |
reduced microbial count 2 weeks
relieving the patient of symptoms 2 weeks
improved survival rate of the tooth : 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improved survival rate of the tootH |
improved survival rate of the tooth : 5 years |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3 |
|
Date of First Enrollment (India)
|
24/07/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a Randomised, parallel group trial that compares effectiveness of Terminalia chebula extract as an intracanal medicament with calcium hydroxide in persistent endodontic infection cases. the primary outcome measures will be relief in symptoms and reduced microbial count at 2 weeks and expected increase in survival rate of the tooth. |