| CTRI Number |
CTRI/2020/08/027260 [Registered on: 20/08/2020] Trial Registered Prospectively |
| Last Modified On: |
11/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the efficacy of garlic-lemon with sodium hypochlorite in reducing microbial load of infected root canals. |
|
Scientific Title of Study
|
Quantitative Analysis of Antimicrobial Efficacy of Garlic-lemon on Comparison with Sodium hypochlorite - A Double Blinded 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 |
Riluwan Siddique |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
Department of conservative dentistry and endodontics
clinic no: 21
Saveetha dental college
Chennai
Poonamalle high road
Tamil nadu
600056
INDIA
Chennai
TAMIL NADU
600056
India |
| Phone |
09743056316 |
| Fax |
|
| Email |
riluwanas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manish Ranjan |
| Designation |
Associate Professor |
| Affiliation |
Saveetha dental college |
| Address |
Department of conservative dentistry and endodontics
clinic no: 21
Saveetha dental college
Chennai
Poonamalle high road
Tamil nadu
600056
INDIA
Chennai
TAMIL NADU
600056
India |
| Phone |
9543445029 |
| Fax |
|
| Email |
manish.mds30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riluwan Siddique |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
Department of conservative dentistry and endodontics
clinic no: 21
Saveetha dental college
Chennai
Poonamalle high road
Tamil nadu
600056
INDIA
Chennai
TAMIL NADU
600056
India |
| Phone |
09743056316 |
| Fax |
|
| Email |
riluwanas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hubert Enviro Care Systems (P) Ltd,
# A-21,III Phase, Behind Lions Club School, Thiru Vi Ka Industrial Estate, Guindy, Chennai – 600 032, Tamilnadu , India |
| VENSONS INDIA
17/1 1st Floor 3rd Cross, ,
Malleswaram,
Bangalore - 560003
Karnataka |
|
|
Primary Sponsor
|
| Name |
Riluwan Siddique |
| Address |
Post graduate student
Department of conservative dentistry and endodontics
clinic no: 21
Saveetha dental college
Chennai
Poonamalle high road
Tamil nadu
600056
INDIA |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Riluwan Siddique |
Saveetha dental college |
Department of Conservative dentistry and endodontics Clinic No : 21 Saveetha dental college Chennai
Poonamalle high road
Chennai
TAMIL NADU
600056
India
Chennai
TAMIL NADU |
9743056316
riluwanas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha institutional human ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Garlic-lemon |
Dose - 1.8%
Route of administration - Intracanal
Duration of therapy - 1 hour
Volume - 15 mL |
| Comparator Agent |
Sodium hypochlorite (NaOCl) |
Dose - 3%
Route of administration - Intracanal
Duration of therapy - 1 hour
Volume - 15 mL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for these patients were as follows: asymptomatic apical periodontitis, single & multi-rooted teeth with straight canals, intact pulp chamber walls, necrotic pulps confirmed by pulp tests and, clinical and radiographic evidence of asymptomatic apical periodontitis. In multi-rooted teeth, palatal canals of maxillary molars and distal canal of mandibular molars were included. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria were as follows: Teeth with gross carious lesion, crown or root fracture, retreatment, periodontal pocket greater than 4mm |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in microbial load was evaluated using real time polymerase chain reaction |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in microbial load was evaluated using real time polymerase chain reaction |
At baseline |
|
|
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)
|
26/08/2020 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sodium hypochlorite for endodontic treatment has shown to exhibit significant antimicrobial properties with adverse effects such as sodium hypochlorite accidents. Natural irrigants have shown significant antimicrobial action and added advantage of being biocompatible. The current study aims to report a Randomised clinical trial (RCT) to evaluate the antimicrobial efficacy of both Garlic-Lemon and sodium hypochlorite in root canals of teeth with asymptomatic apical periodontitis. |