| CTRI Number |
CTRI/2018/09/015627 [Registered on: 06/09/2018] Trial Registered Prospectively |
| Last Modified On: |
12/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To determine the efficacy of two commerically available herbal products during root canal treatment |
|
Scientific Title of Study
|
Comparative Evaluation of Antimicrobial Efficacy of Two Commercially Available Herbal products as Root Canal Irrigants and Intracanal Medicaments in Primary Endodontic Infection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Goldy Rathee |
| Designation |
PG resident |
| Affiliation |
Sudha Rustagi Dental College |
| Address |
Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics, Sudha Rustagi Dental College, sector 89, Greater Faridabad, Haryana
Faridabad
HARYANA
121008
India |
| Phone |
88261817086 |
| Fax |
|
| Email |
rathee.goldy1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Goldy Rathee |
| Designation |
PG resident |
| Affiliation |
Sudha Rustagi Dental College |
| Address |
Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics, Sudha Rustagi Dental College, sector 89, Greater Faridabad, Haryana
Faridabad
HARYANA
121008
India |
| Phone |
88261817086 |
| Fax |
|
| Email |
rathee.goldy1990@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Goldy Rathee |
| Designation |
PG resident |
| Affiliation |
Sudha Rustagi Dental College |
| Address |
Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics, Sudha Rustagi Dental College, sector 89, Greater Faridabad, Haryana
Faridabad
HARYANA
121008
India |
| Phone |
88261817086 |
| Fax |
|
| Email |
rathee.goldy1990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics, Sudha Rustagi Dental College, sector 89, Greater Faridabad, Haryana |
|
|
Primary Sponsor
|
| Name |
Sudha Rustagi Dental College |
| Address |
Sector 89, Kheri More, Greater Faridabad, Haryana |
| Type of Sponsor |
Other [private dental 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 |
| Rakesh Kumar |
Sudha Rustagi Dental College |
Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics Sudha Rustagi Dental College
Faridabad
HARYANA |
9813172742
mttlrksh@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Sudha Rustagi College of Dental Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine gluconate |
2% chlorhexidine gluconate Irrigation will be doing with 6ml of the irrigants and the canals were dried and the
solutions were used as intracanal medicament and placed inside the root canals with
the help of paper point. |
| Intervention |
intracanal irrigants and medicaments |
to disinfect the canal during and between appointment |
| Comparator Agent |
neem juice extract and tulsi juice extract |
Irrigation will be doing with 6ml of the irrigants and the canals were dried and the solutions were used as intracanal medicament and placed inside the root canals with the help of paper point. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non-contributory medical history, intact permanent
teeth without any previous restoration, teeth with necrotic or infected pulp as
diagnosed clinically and radiographically, teeth with adequate coronal structure for
proper isolation, temporization, and restoration were included. |
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions, acute periapical abscess,
retreatment cases, patients on antibiotic therapy within three months, teeth with
calcified canals, sinus opening, immature apex, internal or external resorption, teeth
with periodontal pockets >5 mm were excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in bacterial count |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Colony counts in different groups at stages S1, S2 and S3. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/09/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2018 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Thirty patients with thirty single rooted teeth of
the age 15-50 years will be selected for the study. Prior clearance of the
protocol from the Ethical committee and informed consent from each patient will
be taken.
Inclusion criteria:
Patients with non-contributory medical history, intact permanent teeth
without any previous restoration, teeth with necrotic or infected pulp as
diagnosed clinically and radiographically, teeth with adequate coronal
structure for proper isolation, temporization, and restoration will be
included.
Exclusion criteria : Patients with systemic
conditions, acute periapical abscess, retreatment cases, patients on antibiotic
therapy within three months, teeth with calcified canals, sinus opening,
immature apex, internal or external resorption or periodontal pockets >5 mm will
be excluded.
INSTRUMENTATION:
FIRST TREATMENT SESSION:
Each tooth will be anaesthetized and isolated with
rubber dam followed by caries removal. Oral cavity along with the experimental
tooth will be disinfected with the Betadine solution. Access cavity will be
prepared and the working length will be determined radiographically by using
size #10 K-file to the apex; this length will be premeasured and the working
length will be set 1mm short of this distance. Pretreatment Sample (S1) will be
obtained by injecting normal saline (5ml) into the root canal and
circumferentially pumping a #10 K-file (1 mm short of working length). A sterile paper point will be inserted after
immersing it into the transport media and placing into the canal for 60 sec. It
will be immediately transported to the test tube containing transport media.
Three paper point samples will be taken for each tooth. Biomechanical
preparation will be done using step back technique up to master apical size
#40.The two experimental solutions and chlorhexidine gluconate as the positive
control will be used as irrigants as follows.
Group I: 2%
Chlorhexidine gluconate
Group II: Neem Juice extract
Group III: Tulsi juice extract
Irrigation will be done with 6ml of the irrigants.
Followed by collection of post instrumentation sample (S2) in the same manner
as S1. It will be sent to laboratory for processing within 2 hours. After
second sampling, the canals will be dried and the two experimental solutions
and chlorhexidine gluconate as the positive control will be used as medicaments
and placed inside the root canals:
Group I: 2%
Chlorhexidine gluconate
Group II: Neem Juice extract
Group III: Tulsi juice extract
A cotton pellet will be placed inside the pulp
chamber. Double seal of Cavit G will be placed.
SECOND TREATMENT SESSION-
Patients will be recalled after 7 days. After
isolation and disinfection of the tooth and the oral cavity, the temporary
restoration will be removed. Collection of post medication sample (S3) will be
taken in the same manner as S1 and S2. Teeth will be obturated by lateral
condensation technique using 2% GP and AH plus as sealer and restored with composite.
Microbiological samples (S1, S2, S3) will be
preincubated for 30 minutes and shaken vigorously in a vortex mixture for 60
seconds and then will be plated on Brain heart infusion agar and colonies will
be counted after 24 hours using classic bacterial counting method. |