| CTRI Number |
CTRI/2018/03/012780 [Registered on: 23/03/2018] Trial Registered Prospectively |
| Last Modified On: |
18/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Cleaning of the teeth with different techniques |
|
Scientific Title of Study
|
Evaluation of various irrigation activation systems on the elimination of bacteria from the root canal system: a prospective randomized control single blind trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
Department of Conservative Dentistry & Endodontics, Manipal College of Dental Sciences, MAHE
Department of Conservative Dentistry & Endodontics, Manipal College of Dental Sciences, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9880626167 |
| Fax |
|
| Email |
drballal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
MCODS |
| Address |
Department of Conservative Dentistry & Endodontics, Manipal College of Dental Sciences, MAHE
ANAGHA, Rabindranath Tagore Road Opp to MGM College Kunjebettu Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
drballal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasudev Ballal |
| Designation |
Professor |
| Affiliation |
MCODS |
| Address |
Department of Conservative Dentistry & Endodontics, Manipal College of Dental Sciences, MAHE
ANAGHA Rabondrnath Tagore Road Opp MGM College Kunjebettu Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
drballal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| FKG Dentaire Company, Zurich Switzerland |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences |
| Address |
Manipal College of Dental Sciences Manipal MAHE Karnataka India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vasudev Ballal |
Department of Conservative Dentistry & Endodontics MAHE Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vasudev Ballal |
Manipal College of Dental Sciences |
Department of Conservative Dentistry & Endodontics Manipal College of Dental Sciences, MAHE
Udupi
KARNATAKA |
9880626167
drballal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, Teeth with apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Needle |
Needle irrigation |
| Intervention |
XP Endofinisher |
Rotary files to activate the root canal irrigant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who have teeth (single or multi-rooted) with asymptomatic apical periodontitis
verified with radiographs electric pulp testing and cold test (in case of multirooted teeth, the larger canal will be considered)
2) Teeth with sound periodontium (absence of bleeding on probing, sulcus depth £ 3 mm; no loss of attachment);
3) Patients 18 years of age or above and willing/able to give consent.
|
|
| ExclusionCriteria |
| Details |
1) Patients who had received antibiotics during the previous 3 months;
2) Tooth which cannot be isolated properly by rubber dam;
3) Teeth with radiographic evidence of complete calcification/obliteration of pulp chamber and root canal; internal or external root resorption; open apex; or previous endodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in microbial load |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| healing of apical periodontitis |
1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/04/2018 |
| 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="2"
Months="0"
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)?
|
|
Brief Summary
|
This trial evaluates for the efficacy of needle irrigation, XP endo finisher file activation, ultrasonic activation and F file activation along with NaOCl irrigation in reducing the microbial load from the infected root canal system. |