CTRI Number |
CTRI/2018/04/013313 [Registered on: 17/04/2018] Trial Registered Retrospectively |
Last Modified On: |
12/04/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Evaluation of Zinc oxide-Propolis mixture as root canal filling material in primary molars - A 2 year clinical trial |
Scientific Title of Study
|
Invivo evaluation of Zinc oxide-Propolis mixture as root canal filling material in primary molars |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
KAKARLA SRI ROJA RAMYA |
Designation |
MDS |
Affiliation |
Vishnu Dental College |
Address |
Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram, West Godavari district Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram, West Godavari district West Godavari ANDHRA PRADESH 534202 India |
Phone |
8985774540 |
Fax |
|
Email |
roja.ramya86@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
K SRI ROJA RAMYA |
Designation |
MDS |
Affiliation |
Vishnu Dental College |
Address |
Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram. Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram - 534202 West Godavari ANDHRA PRADESH 534202 India |
Phone |
8985774540 |
Fax |
|
Email |
roja.ramya86@gmail.com |
|
Details of Contact Person Public Query
|
Name |
K SRI ROJA RAMYA |
Designation |
MDS |
Affiliation |
Vishnu Dental College |
Address |
Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram. Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram, West Godavari district West Godavari ANDHRA PRADESH 534202 India |
Phone |
8985774540 |
Fax |
|
Email |
roja.ramya86@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
KAKARLA SRI ROJA RAMYA |
Address |
Dr KS Roja Ramya, Department of pedodontics, Block III, Room no. 5, Vishnu dental college, Bhimavaram, West Godavari District, 534202 |
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 |
Dr K Sri Roja Ramya |
Vishnu Dental college |
Department of pedodontics, Block III, Room no. 5, Bhimavaram West Godavari ANDHRA PRADESH |
8985774540
roja.ramya86@gmail.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
|
Health Type |
Condition |
Patients |
Infected primary molars, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Zinc oxide-Eugenol |
Zinc oxide powder, Deepak enterprises, Mumbai, India; Eugenol,Prime Dental Products Pvt. Ltd, Thane, India.
|
Intervention |
Zinc oxide-Propolis mixture |
Zinc oxide powder, Deepak enterprises, Mumbai, India;
Brazilian Green Propolis alcohol free 60%, Uniflora Health foods, Brazil.
|
|
Inclusion Criteria
|
Age From |
4.00 Year(s) |
Age To |
8.00 Year(s) |
Gender |
Both |
Details |
Primary molars with signs of chronic irreversible pulpitis with extra-oral or intra-oral swelling, sinus opening, grade I mobility due to periradicular infection, radiographic evidence of minimum bone degeneration were included in the study. |
|
ExclusionCriteria |
Details |
Primary molars with less than two thirds of remaining root length and teeth with non-restorable crown structure, molars demonstrating extensive external or internal resorption, molars exhibiting greater than grade I mobility and children who are allergic to propolis were excluded.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Success of Zinc oxide-Propolis mixture filled teeth
Success of Zinc oxide Eugenol filled teeth |
24 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Success of Zinc oxide-Propolis mixture filled teeth
Success of Zinc oxide Eugenol filled teeth |
6 months and 12 months |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
16/07/2014 |
Date of Study Completion (India) |
21/07/2016 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="5" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This study was conducted to evaluate and compare the clinical efficacy of Zinc oxide-Propolis mixture with Zinc oxide Eugenol as root canal filling material in infected primary molars. This study is a randomized, double blind, trial comprising of 40 primary molars from the children aged 4-8yrs which were divided into two groups according to the obturating material used: Test group: Zincoxide-Propolis mixture; control group: Zinc oxide Eugenol. All the pulpectomy treated teeth were finally restored with stainless steel crowns and the children were recalled at 6, 12 and 24 months for post-operative clinical and radiographic evaluation to assess the success rate. The primary outcome measures were success at 24 months. The secondary outcome measures were success at 6 and 12 months. At 6 month follow-up, Zincoxide–Propolis mixture has shown 100% success, while Zincoxide Eugenol has shown a success of 80% and the difference was statistically significant(p= 0.035). At 12 month follow-up, Zincoxide–Propolis mixture has shown a success of 95%, while Zincoxide Eugenol has shown a success of 80%. At 24 month follow-up, Zincoxide–Propolis mixture has shown 95% success, while Zincoxide Eugenol has shown a success of 70% and the difference was statistically significant(p= 0.037). Zincoxide–Propolis mixture demonstrated good clinical and radiographic success at 24 months follow-up and hence it can be used as an alternate root canal filling material in primary teeth. |