| CTRI Number |
CTRI/2024/05/067682 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of Natural vs Synthetic MMP inhibitors in patients with pulpal necrosis and apical periodontitis |
|
Scientific Title of Study
|
Comparative evaluation of Natural vs Synthetic MMP inhibitors on MMP-2 and MMP-9 in patients with pulpal necrosis and apical periodontitis – 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 |
Palak Jain |
| Designation |
PG Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
QS-27, Dept of Conservative Dentistry and Endodontics, Manav Rachna Dental College,
Sector – 43, Delhi - Suraj Kund Badkhal Road
Faridabad
HARYANA
121004
India |
| Phone |
9315769696 |
| Fax |
|
| Email |
priya.jain394@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alpa Gupta |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Dept of Conservative Dentistry and Endodontics, Manav Rachna Dental College, Sector – 43, Delhi - Suraj Kund Badkhal Road
Faridabad
HARYANA
121004
India |
| Phone |
9050312010 |
| Fax |
|
| Email |
alpagupta2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Palak Jain |
| Designation |
PG Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
QS-27, Dept of Conservative Dentistry and Endodontics, Manav Rachna Dental College, Sector – 43, Delhi - Suraj Kund Badkhal Road
Faridabad
HARYANA
121004
India |
| Phone |
9315769696 |
| Fax |
|
| Email |
priya.jain394@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College
Sector–43,Delhi - Suraj Kund Badkhal Road, Faridabad, Haryana - 121004. |
|
|
Primary Sponsor
|
| Name |
Palak Jain |
| Address |
Room no 7, Dept of Conservative Dentistry and Endodontics,
Manav Rachna Dental College, Sector – 43, Delhi - Suraj Kund Badkhal Road, Faridabad, Haryana - 121004 · |
| 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 Palak Jain |
Manav Rachna Dental College |
Dept of Conservative Dentistry and Endodontics, Manav Rachna Dental College, Sector – 43, Delhi - Suraj Kund, Badkhal Road
Faridabad
HARYANA |
09315769696
priya.jain394@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manav Rachna Dental College |
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 with 2% Chlorhexidine |
Calcium Hydroxide with 2% Chlorhexidine (1gm/ml) placed as Intracanal medicament for 7 days |
| Intervention |
Epigallocatechin Gallate |
Epigallocatechin Gallate (0.04mg/ml) placed as Intracanal medicament for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Mandibular premolar and canine teeth diagnosed with pulp necrosis and apical periodontitis
2 Teeth with mature apices
3 Patients with age between 18 - 60 years
|
|
| ExclusionCriteria |
| Details |
1 Teeth with calcified canals and aberrant root canal morphology.
2 Pregnant or lactating patients
3 Patients with history of allergy to any of the components of local anaesthesia
4 Teeth with previous RCT
5 Severely damaged or mutilated teeth
6 Patient with systemic disease
7 Patient with periodontal disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measure the level of MMP-2 and MMP-9 in Calcium hydroxide with 2% Chlorhexidine and Epigallocatechin gallate groups in patients with pulpal necrosis and apical periodontitis. |
Before placement of Intracanal medicament and after 7 days of placement of Intracanal medicament. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare levels of MMP-2 & MMP-9 in patients with pulpal necrosis & apical periodontitis treated using
Calcium Hydroxide with 2% Chlorhexidine & in patients with pulpal necrosis & apical periodontitis treated using epigallocatechin gallate using sandwich ELISA |
Before placement of intracanal medicament & 7 days after placement of intracanal medicament |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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) |
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
|
·To evaluate levels of mmp-2 in
patients with pulpal necrosis and apical periodontitis using Calcium Hydroxide with 2%
Chlorhexidine as intracanal
medicament using
sandwich ELISA
·To evaluate levels of mmp-2 in patients
with pulpal necrosis and apical periodontitis using Epigallocatechin gallate as intracanal medicament using sandwich ELISA
·To evaluate levels of mmp-9 in patients
with pulpal necrosis and apical periodontitis using Calcium Hydroxide with 2%
Chlorhexidine as intracanal
medicament using
sandwich ELISA
• ·To evaluate levels of mmp-9 in patients
with pulpal necrosis and apical periodontitis using Epigallocatechin gallate as intracanal medicament using sandwich ELISA
·To compare levels of mmp-2 in patients with pulpal necrosis and apical
periodontitis
treated using Calcium
Hydroxide with 2% Chlorhexidine and in patients with pulpal necrosis and apical
periodontitis
treated using epigallocatechin gallate using sandwich ELISA
·To compare levels of mmp-9 in patients with pulpal necrosis and apical
periodontitis
treated using Calcium
Hydroxide with 2% Chlorhexidine and in patients with pulpal necrosis and apical
periodontitis
treated using epigallocatechin gallate using sandwich ELISA |