| CTRI Number |
CTRI/2019/04/018540 [Registered on: 10/04/2019] Trial Registered Prospectively |
| Last Modified On: |
09/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of three rotary instruments in reducing microbial load of infected root canals. |
|
Scientific Title of Study
|
Comparing Antibacterial Efficacy of Three Rotary System with Different Geometry in Infected Root Canals Before and After Instrumentation – 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 |
Post graduate student
Department of Conservative dentistry and endodontics
Clinic No : 21
Saveetha dental college
Chennai
Poonamalle high road
Chennai
TAMIL NADU
600056
India |
| Phone |
09743056316 |
| Fax |
|
| Email |
riluwanas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nivedhitha malli sureshbabu |
| Designation |
Professor and Head |
| Affiliation |
Saveetha dental college |
| Address |
Professor and Head
Department of conservative dentistry and endodontics
Saveetha dental college
Chennai
TAMIL NADU
600056
India |
| Phone |
9840912367 |
| Fax |
|
| Email |
Nivea16@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riluwan siddique |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
Post graduate student
Department of Conservative dentistry and endodontics
Clinic no : 21
Saveetha dental college
Chennai
Chennai
TAMIL NADU
600056
India |
| Phone |
9743056316 |
| Fax |
|
| Email |
riluwanas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dentsply India pvt Ltd No. 1308, 5th floor , shetty plaza, above bata show room, Hal 3rd stage , jeevan bhima nagar, Bangalore 560008
Confident sales India Pvt Ltd No. 47, 2nd floor , Pete Channappa Ind. Estate, Magadi main road, Kamakshipalya , Bangalore |
|
|
Primary Sponsor
|
| Name |
riluwan siddique |
| Address |
Post graduate student
Conservative dentistry and endodontics
Saveetha dental college
Chennai |
| 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 |
Post graduate student
Conservative dentistry & Endodontics
Saveetha dental college
Chennai
Tamilnadu
Chennai
TAMIL NADU |
09743056316
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 |
| Healthy Human Volunteers |
Infected root canals(asymptomatic apical periodontitis) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ProTaper Gold |
Rotary system |
| Comparator Agent |
ProTaper Next |
Rotary system |
| Intervention |
XP Endoshaper |
Rotary system |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
: 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 |
|
| ExclusionCriteria |
| Details |
Teeth with gross carious lesion, crown or root fracture, retreatment, periodontal pocket deeper than 4mm were excluded. |
|
|
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 |
Samples were collected from infected root canals on same day of treatment procedure. No follow up samples collected
Samples collected before instrumentation(S1 samples)
Samples collected after instrumentation (S2 samples) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in microbial load was evaluated using real time polymerase chain reaction. |
Samples were collected from infected root canals on same day of treatment procedure. No follow up samples collected
Samples collected before instrumentation(S1 samples)
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
12/04/2019 |
| 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="3"
Days="10" |
|
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)?
|
|
Brief Summary
|
One of the major goals of the treatment of infected root canals of teeth with apical periodontitis is to promote maximal reduction in intracanal bacterial population.ProTaper Next was developed as the successor of the ProTaper Universal system.The Protaper next system was as effective as Protaper Universal and WaveOne in the removal of bacteria during root canal treatment.Recently introduced ProTaper Gold was found to produce less transportation compared to ProTaper Universal . XP-endo Shaper (XP) was introduced in 2015 and boasts of new rotary NiTi snake-shaped instrument developed with MaxWire technology. It has been proved that the XP Endoshaper follows the root canal anatomy of oval shaped canals by preparing and touching more walls than the Vortex Blue system.Till date no study has related to antimicrobial efficacy regarding ProTaper Next,ProTaper Gold and XP Endoshaper in clinical trials. Therefore aim of this randomized controlled clinical trial was to compare the microbial load reduction of ProTaper Next, ProTaper Gold and XP Endoshaper in infected root canals of teeth with asymptomatic apical periodontitis. The null hypothesis was that there was no statistically significant difference in microbial load reduction between three rotary systems. |