| CTRI Number |
CTRI/2020/09/027510 [Registered on: 01/09/2020] Trial Registered Prospectively |
| Last Modified On: |
19/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of etidronic acid as a cleaning agent against primary teeth root canal
microorganism |
|
Scientific Title of Study
|
Evaluation of antimicrobial efficacy of Etidronic acid 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 [] |
|
|
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 |
Room No 8 Dental 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 |
| Comparator Agent |
Chlorhexidine gluconate |
0.5 ml of 2% Chlorhexidine gluconate for 5 seconds will be used as an root canal irrigant. Chlorhexidine gluconate has antimicrobial property and is used as an irrigant in primary teeth. It has the property of substantivity. |
| Intervention |
Etidronic acid |
0.5 ml of 9% etidronic acid for 5
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. |
|
|
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 Chlorhexidine gluconate as an irrigant in primary teeth. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Chlorhexidine gluconate may have better antimicrobial
property than Etidronic acid as an irrigant in primary
teeth. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2020 |
| 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 60 teeth from the patients requiring pulpectomy of 3 to 8 years old after obtaining a written informed consent from the parents of child. 60 teeth requiring pulpectomy will be divided into two groups using following irrigants: Group I (n=30 teeth): 2% Chlorhexidine gluconate and Group II (n=30 teeth): 9% Etidronic acid. 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: 0.5 ml of 2% Chlorhexidine gluconate for 5 seconds will be used as an irrigant and Group II: 0.5 ml of 9% Etidronic acid for 5 seconds will be used as an irrigant. 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. |