| CTRI Number |
CTRI/2020/08/027096 [Registered on: 11/08/2020] Trial Registered Prospectively |
| Last Modified On: |
27/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of etidronic acid and propolis as irrigants against primary teeth root canal microorganism |
|
Scientific Title of Study
|
Comparision and evaluation of antimicrobial efficacy of Etidronic acid and Propolis against E. faecalis in primary teeth: 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 |
Atluri Naga Supraja |
| Designation |
Post Graduate |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room No 8 Dental Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9866834589 |
| Fax |
|
| Email |
supraja.atluri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena Arali |
| Designation |
Professor and HOD |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room No 8 Dental Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
7760748787 |
| Fax |
|
| Email |
gslpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Atluri Naga Supraja |
| Designation |
Post Graduate |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room No 8 Dental Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9866834589 |
| Fax |
|
| Email |
supraja.atluri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry 533296 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Atluri Naga Supraja |
GSL Dental College and Hospital |
Department of Pediatric and Preventive Dentistry GSL Dental and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry 533296
East Godavari
ANDHRA PRADESH |
9866834589
supraja.atluri@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 |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etidronic acid |
2 ml of 9% etidronic acid for 20 seconds will be used as an root canal irrigant. Etidronic acid has an antimicrobial property and is used as an irrigant in primary teeth
It is used to treat osteoporosis. |
| Comparator Agent |
Propolis |
2 ml of 25% Propolis for 20 seconds will be used as an root canal irrigant. Propolis is a natural agent which is used as an irrigant in primary teeth due to its antimicrobial property. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Patients having optimum systemic health.
Primary teeth with atleast one necrotic pulp canal, abscess, or sinus tract.
Primary teeth with presence of radiolucency in furcation or periapical region.
Primary teeth with atleast two thirds of root present.
Sufficient tooth structure to support a rubber dam.
|
|
| ExclusionCriteria |
| Details |
Patient on antibiotics upto 2 weeks prior to the study or having any systemic illness.
Primary teeth which are non restorable,with pulpal floor or with mobility.
Primary teeth with less than two thirds present.
Teeth which doesnot support rubber dam application. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Etidronic acid may have better antimicrobial property than Propolis as an irrigant in primary teeth |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Etidronic acid may be equally efficient to Propolis in antimicrobial activity as an irrigant in primary teeth |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
08/10/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An interventional, double blinded, randomised parallel group trial will
be conducted in 30 teeth from the patients requiring pulpectomy of 3 to 8 years
old after obtaining a written informed consent from the parents of child.
30 teeth requiring pulpectomy will be divided into two groups using following
irrigants: Group I (n=15 teeth): 9% Etidronic acid and Group II (n=15 teeth):
Propolis. Appropriate local anesthesia will be given and the tooth will be
isolated with rubber dam. The gross carious tissue will be removed and initial
access opening will be done with No. 3 round carbide bur. Working length will
be determined with preoperative intraoral periapical radiograph. First
microbiological sample will be obtained with 2 sterile absorbent paper points
each for 30 seconds from the root canal (pre irrigation) and will be
immediately immersed into test tube with Brain Heart Infusion Broth (BHI).
Conventional biomechanical preparation will be done upto 35 k-file. During
instrumentation after each file, Group I: 2 ml of 9% Etidronic acid for 20
seconds will be used as an irrigant and Group II: 2 ml of Propolis for 20 seconds will be used as an
irrigant. The activation of irrigants will be done with waterpik. Final
irrigation of canals will be done at the end of instrumentation and dried
before obturating and second microbiological sample will be collected with
another 2 sterile absorbent paper points each for 30 seconds. The root canal
will be filled with a obturating material and a postoperative intraoral periapical
radiograph will be taken. The collected samples will be subjected to
microbiological analysis to determine the number of colony forming units
against E. faecalis. The obtained results will be subjected to statistical
analysis. |