| CTRI Number |
CTRI/2018/08/015435 [Registered on: 23/08/2018] Trial Registered Prospectively |
| Last Modified On: |
22/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study comparing the effect of two concentrations of antibiotic filling material used in the treatment of deep dental caries in children. |
|
Scientific Title of Study
|
Comparison Of Two Concentrations Of Modified Triple Antibiotic Paste In Lesion Sterilization And Tissue Repair on Primary Molars – An In Vivo Interventional Randomized Clinical Trail. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthika Shankar |
| Designation |
PG student |
| Affiliation |
SRM Dental College |
| Address |
SRM University, Bharathi Salai, Ramapuram,Chennai.
Chennai
TAMIL NADU
600 089
India |
| Phone |
7708505840 |
| Fax |
|
| Email |
ashwini_shankar@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemalatha |
| Designation |
Professor and HOD |
| Affiliation |
SRM Dental College |
| Address |
SRM University, Bharathi Salai, Ramapuram,Chennai.
Chennai
TAMIL NADU
600 089
India |
| Phone |
9840188571 |
| Fax |
|
| Email |
srmpedodpt16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthika Shankar |
| Designation |
PG student |
| Affiliation |
SRM Dental College |
| Address |
SRM University, Bharathi Salai, Ramapuram,Chennai.
Chennai
TAMIL NADU
600 089
India |
| Phone |
7708505840 |
| Fax |
|
| Email |
ashwini_shankar@ymail.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental college, Ramapuram, Chennai, India |
|
|
Primary Sponsor
|
| Name |
SRM Dental college and hospital |
| Address |
Bharathi Salai, Ramapuram,
Chennai-89 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| S Karthika |
SRM Dental college |
Department of Pedodontics and Preventive dentistry,
IIIrd floor, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089
Chennai
TAMIL NADU |
7708505840
ashwini_shankar@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Triple antibiotic paste at 1gram/ml concentration |
Ciprofloxacin, Metronidazole and Clindamycin with Propylene glycol. |
| Intervention |
Triple antibiotic paste at 1mg/ml concentration |
Ciprofloxacin, Metronidazole and Clindamycin with Propylene glycol. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group between 4 to 10 yrs
2) Children with deep caries involving pulp in primary molars.
3) Irreversible pulpitis with clinical, periapical or furcal lesions.
4) Primary molars with or without physiologic root resorption.
|
|
| ExclusionCriteria |
| Details |
1) Special children with physical or emotional alteration.
2) Children with systemic diseases
3) Previous history of allergy to antibiotics used in the study.
4) Grossly decayed, unrestorable teeth.
•Caries in primary teeth exhibiting pre shedding mobility.
|
|
|
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 |
| Clinical and radiographic success of treatment based on Coll and Sadrian criteria |
10 days, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Success of LSTR at 1 month and 3 months follow up |
1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2018 |
| Date of Study Completion (India) |
11/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, double blind, parallel group, interventional study comparing the efficacy of triple antibiotic paste in ’Lesion Sterilization and tissue repair’ (LSTR) at 1gm/ml and 1mg/ml concentration placed locally for the treatment of deep carious lesions in 64 primary molars that will be conducted in the out patient department of SRM Dental college, India. |