| CTRI Number |
CTRI/2021/12/038942 [Registered on: 27/12/2021] Trial Registered Prospectively |
| Last Modified On: |
26/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare three different root canal filling material in Children |
|
Scientific Title of Study
|
A Clinical and Radiographic Comparative Study Between Zinc
Oxide Eugenol Syzygium cumini Mixture, Zinc Oxide Eugenol Propolis Mixture And Zinc Oxide Eugenol As Obturating
Materials in Primary Molars: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaviya Saraswati Gangji |
| Designation |
MDS Student |
| Affiliation |
Bapuji Dental College And Hospital |
| Address |
Room No 3, Department of Pediatrics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere
Davanagere
KARNATAKA
577004
India |
| Phone |
7738094620 |
| Fax |
|
| Email |
dr.saraswati123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raju O S |
| Designation |
Professor and PG Guide |
| Affiliation |
Bapuji Dental College And Hospital |
| Address |
Room No 3, Department of Pediatrics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere
Davanagere
KARNATAKA
577004
India |
| Phone |
9845151024 |
| Fax |
|
| Email |
drrajuos@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raju O S |
| Designation |
Professor and PG Guide |
| Affiliation |
Bapuji Dental College And Hospital |
| Address |
Room No 3, Department of Pediatrics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere
Davanagere
KARNATAKA
577004
India |
| Phone |
9845151024 |
| Fax |
|
| Email |
drrajuos@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere - 577004 |
|
|
Primary Sponsor
|
| Name |
Vaviya Saraswati Gangji |
| Address |
Room No 3, Department of Pediatrics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR RAJU O S |
ROOM NO 3, DEPARTMENT OF PEDIATRICS AND PREVENTIVE DENTISTRY, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vaviya Saraswati Gangji |
Bapuji Dental College And Hospital |
RRoom No 3, Department of Pediatrics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere
Davanagere
KARNATAKA |
7738094620
dr.saraswati123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUINTIONAL REVIEW BOARD, BAPUJI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ZINC OXIDE EUGENOL
PROPOLIS MIXTURE |
Preparation of zinc oxide eugenol Propolis mixture will be done by mixing propolis extract powder with propylene glycol as a solvent at concentration of 200 mg/ml and then it will be mixed with ZOE at the ratio of 1:2. |
| Comparator Agent |
ZINC OXIDE EUGENOL |
Zinc oxide powder and eugenol will be dispensed on glass slab according to manufacturer instructions and then will be mixed to a desired consistency for obturation.
|
| Intervention |
ZINC OXIDE EUGENOL SYZYGIUM CUMINI MIXTURE |
Preparation of zinc oxide eugenol syzygium cumini mixture will be done by mixing the seed extract powder with propylene glycol as a solvent at a concentration of 200 mg/ml and then it will be mixed with ZOE at the ratio of 1:2. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
One or more of the following criteria will be included for pulpectomy
- Caries-affected teeth with intra-oral and/or extra-oral swelling or intra oral draining sinus
tract.
- Teeth with deep caries lesions and associated inter-radicular and/or periapical
radiolucency’s.
- Caries-affected teeth with abnormal mobility due to periapical pathosis, but not associated
with normal exfoliation.
- History of spontaneous pain with tenderness on percussion |
|
| ExclusionCriteria |
| Details |
- Primary molars with less than two-thirds of the remaining root length.
- History of allergic reaction to local anaesthetics.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - Clinical evaluation and radiographic evaluation |
Immediate, 3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/01/2022 |
| 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="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, single centre trial comparing the effectiveness of the zinc oxide eugenol with syzygium cumini mixture, zinc oxide eugenol with propolis mixture and zinc oxide eugenol when used as obturating materials in primary molars will be conducted at Bapuji Dental College and Hospital in Karanataka, India. The standard pulpectomy procedure will be followed by obturation with above mentioned materials. The primary outcome measure will be clinical and radiographic evaluation at 3 months, 6 months, 12 months intervals. |