| CTRI Number |
CTRI/2021/09/036856 [Registered on: 27/09/2021] Trial Registered Prospectively |
| Last Modified On: |
25/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparasion of tubulicid and chlorhexidine as a cavity disinfectant in primary teeth |
|
Scientific Title of Study
|
Evaluation of antimicrobial efficacy of Tubulicid, a cavity disinfectant against S.mutans 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 |
Deviswapnika |
| Designation |
Postgraduate |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room No 8
department of pediatric and preventive dentistry
GSL Dental College and Hospital
NH 16 lakshmipuram Rajahmundry East Godavari
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9492118444 |
| Fax |
|
| Email |
swaapnikachowdary333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena Arali |
| Designation |
Professor and Head of the Department |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room no 8
department of pediatric and preventive dentistry
GSL Dental College and Hospital
NH 16 lakshmipuram Rajahmundry East Godavari
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
7760748787 |
| Fax |
|
| Email |
gslpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deviswapnika |
| Designation |
Postgraduate |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room no 8
department of pediatric and preventive dentistry
GSL Dental College and Hospital
NH 16 lakshmipuram Rajahmundry East Godavari
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9492118444 |
| Fax |
|
| Email |
swaapnikachowdary333@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Lakshmipuram Rajahmundry 533296 |
|
|
Primary Sponsor
|
| Name |
Daniel Kratt |
| Address |
Daniel Kratt
0724307161
Dental Therapeutics AB
Paviljongvagen 3 4TR PK8355
13240SALTSJOBOO
Sweden |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| DEVISWAPNIKA |
GSL Dental College and Hospital |
Room no 8 Dental Department of Pediatric and Preventive Dentistry NH 16 Lakshmipuram Rajahmundry
East Godavari
ANDHRA PRADESH |
9492118444
swaapnikachowdary333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, (2) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine |
1 ml of chlorhexidine, a cavity disinfectant for 60 seconds for 1 time due to its antimicrobial property against streptococcus mutans |
| Intervention |
TUBULICID RED |
1 ml of Tubulicid Red, a cavity disinfectant will be applied for 60 seconds for 1 time and it will be rinsed with saline. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Carious primary teeth involving till 2/3 rd of dentin
No clinical and radiographic signs of pulpal involvement
|
|
| ExclusionCriteria |
| Details |
Patients who had received antibiotics up to 2 weeks prior to the sampling or having any systemic compromise
Patients who had non-restorable teeth perforated pulpal floor excessive mobility or pathological root resorption or caries involving the pulp
|
|
|
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 |
| Tubulicid may have better antimicrobial property against steptococcus mutans by evaluating under colony counter in the sample collected from the cavity after application of cavity disinfectant for 60 seconds |
60seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chlorhexidine may have better antimicrobial property against streptococcus mutans by evaluating under colony counter in the sample collected from the cavity after application of chlorhexidine for 60 seconds |
60 seconds |
|
|
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)
|
01/10/2021 |
| 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)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-10-2022 and end date provided 01-10-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
An interventional, double-blinded, the randomized parallel-group will be conducted in 60 primary teeth of 4 to 10 years old children who have class 1 dental caries, after obtaining the written informed consent from the parents of the child 60 primary teeth requiring restoration will be divided into two groups using the lottery method. Group I (n=30 teeth)Chlorohexidine as cavity disinfectant, Group II (n=30 teeth): Tubulicid Red as cavity disinfectant. The tooth will be isolated with a rubber dam and the carious dentin will be excavated using a spoon excavator. Based on color, consistency the infected dentin will be removed, affected dentin will be leftover. Then the dentinal sample will be collected from the base of the cavity using a sterile spoon excavator before and after application of the disinfecting agents for 60 sec. After rinsing with saline, the cavity is restored with either GIC or composite material. The collected dentinal sample will be transferred into Eppendorf tubes containing 0.5ml of phosphate buffer solutions. Two microliters of the samples collected before and after disinfection will be inoculated on the mutans sanguis (MS) agar (M997; Himedia, India) a selective medium for Streptococcus mutans (MS). The plates will be incubated for 72 hrs in an atmosphere containing 5% Co2 and 95% N2 at 37°C. Colony forming units on the plates will be counted using the colony counter. |