| CTRI Number |
CTRI/2017/06/008749 [Registered on: 05/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
21/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing three different root canal filling methods in milk teeth |
|
Scientific Title of Study
|
Comparative Evaluation of Three Obturating Techniques in Primary Molars- An in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ellana Jermiah Joseph |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Manipal College Of Dental Sciences,Paedontics and preventive Dentistry, room no.5,Light House Hill Road, Mangalore - 575001
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9819550693 |
| Fax |
|
| Email |
ellana_j@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arathi Rao |
| Designation |
HOD and Guide |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Manipal College Of Dental Sciences,Paedontics and preventive Dentistry, room no.5,Light House Hill Road, Mangalore - 575001
Dakshina Kannada
KARNATAKA
575001
India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9845242079 |
| Fax |
|
| Email |
arathi.rao@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Arathi Rao |
| Designation |
HOD and Guide |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Manipal College Of Dental Sciences,Paedontics and preventive Dentistry, room no.5,Light House Hill Road, Mangalore - 575001
Dakshina Kannada
KARNATAKA
575001
India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9845242079 |
| Fax |
|
| Email |
arathi.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal college of dental sciences, Mangalore |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Ellana Jermiah Joseph |
Manipal College of Dental Sciences |
Light House Hill Road,,Department of Pedodontics and Preventive Dentistry, room no 5. Mangalore - 575001
Dakshina Kannada
KARNATAKA Dakshina Kannada KARNATAKA |
9833814041
ellana_j@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,MCODS Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Teeth indicated for pulpectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1.Lentulospiral |
1. Mani Co, Tokyo, Japan- zinc oxide eugenol will be used as the obturating material in the powder liquid ratio of 1:2.
Treatment will take 1 hour |
| Intervention |
1.NaviTip®
2.NaviTip® |
1.Ultradent Products, Inc., South Jordan, Utah, USA- zinc oxide eugenol will be used as the obturating material in the powder liquid ratio of 1:3.
2.Double Sideport, Ultradent Products, Inc., South Jordan, Utah, USA- zinc oxide eugenol will be used as the obturating material in the powder liquid ratio of 1:3.
Treatment will take 1 hour |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.All the teeth indicated for pulpectomy
2. Parents who have signed the informed consent form
3. Children who have signed the assent form |
|
| ExclusionCriteria |
| Details |
1.Children with known allergy to zinc oxide eugenol
2. Medically compromised children
3. Physiologic root resorption greater than half of the root length |
|
|
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 |
| Clinical sucess, Radiographic success |
Immediately after the treatment ( 1 hour ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic success, clinical success |
1 hour |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2017 |
| Date of Study Completion (India) |
15/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pulpectomy is one of the treatment options for deciduous teeth where the inflammation has reached the radicular pulp or teeth that have become non- vital.The function of a root canal filling is to obturate the canal and eliminate the portals of entry between the periodontium and the root canal. The obturating material as well as obturation technique used that is capable of densely filling the entire root canal system and providing a fluid tight seal to prevent reinfection also significantly influences the success rate of the endodontic therapy. Several methods have been used to deliver obturating materials into the root canals. Various studies have been conducted using different obturating techniques to fill the pulpectomized canals of primary teeth such as motor driven lentulospiral, hand held lentulospiral, reamer, local anesthetic syringe and a 27-gauge needle, NaviTip® system, endodontic pressure syringe, tuberculin syringe, absorbent paper point etc. . There have been studies where NaviTip® has been proved to create less voids as compared to lentulospiral when used as an obturating technique in primary teeth . Navitip®, Navitip® (Double Sideport) have been used in endodontics for irrigation and has shown good results. It consists of a small cannula which navigates the most intricate canals and the double sideports horizontally express the material toward the canal walls and not to the apex. Navitip® (Double Sideport) has not yet been used for obturation. The present study is thus proposed to evaluate and compare the filling quality of three delivery systems for root canal obturation in primary teeth, that is, Navitip®, Navitip® (Double Sideport) and rotary lentulospiral. |