| CTRI Number |
CTRI/2022/08/044749 [Registered on: 18/08/2022] Trial Registered Prospectively |
| Last Modified On: |
25/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of the levels of immune response in teeth that have undergone cell death after placing simvastatin as an root canal medicine. |
|
Scientific Title of Study
|
Quantitative Assessment of Interleukin-6(IL-6) in Teeth with Pulpal Necrosis and Symptomatic Apical Periodontitis Following Placement of Simvastatin as an Intracanal Medicament- A Prospective Triple-Blind Randomized Controlled Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikhil Harikrishnan |
| Designation |
Post Graduate Student |
| Affiliation |
SRM dental college |
| Address |
SRM Dental College
Department of Conservative Dentistry and Endodontics
2nd Floor
Bharathi Salai
Ramapuram
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9400430067 |
| Fax |
|
| Email |
nikhilmeloth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavitha Sanjeev |
| Designation |
Professor |
| Affiliation |
SRM Dental College |
| Address |
SRM Dental College
Department of Conservative Dentistry and Endodontics
2nd Floor
Bharathi Salai
Ramapuram
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
|
| Fax |
|
| Email |
kavithasanjeev02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravikumar N |
| Designation |
Reader |
| Affiliation |
SRM Dental College |
| Address |
SRM Dental College
Department of Conservative Dentistry and Endodontics
2nd Floor
Bharathi Salai
Ramapuram
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
|
| Fax |
|
| Email |
drravikumar19@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental college , Ramapuram |
|
|
Primary Sponsor
|
| Name |
SRM Dental College |
| Address |
SRM Dental College
Department of Conservative Dentistry and Endodontics
2nd Floor
Bharathi Salai
Ramapuram
Chennai |
| Type of Sponsor |
Private medical college |
|
|
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 Nikhil Harikrishnan |
SRM Dental College |
SRM Dental College
Department of Conservative Dentistry and Endodontics
2nd Floor
Bharathi Salai
Ramapuram
Chennai
Chennai
TAMIL NADU |
9400430067
nikhilmeloth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Review Board |
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 |
1.2g/0.8ml
Frequency/duration for 7 days |
| Intervention |
Simvastatin |
1.2 g/ 100ml
Frequency/Duration for 7days. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA score 1
Healthy patients aged 16-60 years
patients diagnosed with pulpal necrosis and symptomatic apical periodontitis (PAI ≤2)
Single rooted teeth with single canal and closed apex
|
|
| ExclusionCriteria |
| Details |
Patients under ASA 2-5 category.
Patients under any medication for a week.
Patients with periapical pathology (PAI score >2)
Teeth with cracks, vertical root fracture, internal & external resorption.
Multirooted teeth, Single rooted teeth with multiple canals.
Teeth with immature apex. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quantification and comparison of
Interleukin-6 before and after
placement of simvastatin will show
decrease in its concentration |
Samples will be taken before and after biomechanics preparation and after 7 days of intracanal medication placement. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quantification and comparison of
Interleukin-6 before and after
placement of Calcium hydroxide will
show decrease in its concentration. |
Samples will be taken before and after biomechanics preparation and after 7 days of intracanal medication placement. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/08/2022 |
| Date of Study Completion (India) |
26/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a triple-blinded randomized controlled clinical trial aimed to compare and evaluate the levels of interleukin-6 in teeth with pulp necrosis and symptomatic apical periodontitis following placement of simvastatin as an intracanal medicament conducted in Chennai, India with the primary outcome measure being a 10% increased efficacy of simvastatin in reduction of Interleukin -6 levels compared to calcium hydroxide after a period of 7 days. |