| CTRI Number |
CTRI/2019/10/021756 [Registered on: 22/10/2019] Trial Registered Prospectively |
| Last Modified On: |
14/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study temperature rise and antibacterial activity of diode laser for cavity disinfection at two different power settings |
|
Scientific Title of Study
|
Evaluation of temperature rise and efficacy of cavity disinfection with diode laser: 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 |
DR SAKSHI JAIN |
| Designation |
PG STUDENT |
| Affiliation |
ITS-CDSR, MURADNAGAR |
| Address |
ROOM NO. 7, SECOND FLOOR, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ITS-CDSR, DELHI-MEERUT ROAD, MURADNAGAR
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9560509262 |
| Fax |
|
| Email |
sakshi.jain7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAKSHI JAIN |
| Designation |
PG STUDENT |
| Affiliation |
ITS-CDSR, MURADNAGAR |
| Address |
ROOM NO.7, SECOND FLOOR, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ITS-CDSR, DELHI-MEERUT ROAD, MURADNAGAR
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9560509262 |
| Fax |
|
| Email |
sakshi.jain7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHIVANI MATHUR |
| Designation |
PROFESSOR |
| Affiliation |
ITS-CDSR, MURADNAGAR |
| Address |
ROOM NO. 7, SECOND FLOOR, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ITS-CDSR, DELHI-MEERUT ROAD, MURADNAGAR
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
8826221676 |
| Fax |
|
| Email |
shivanimathur.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS-CDSR, MURADNAGAR, GHAZIABAD, UTTAR PRADESH |
|
|
Primary Sponsor
|
| Name |
DR SAKSHI JAIN |
| Address |
ITS-CDSR, MURADNAGAR, GHAZIABAD, UTTAR PRADESH |
| 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 Sakshi Jain |
ITS-CDSR |
Room No. 7 Department of Pediatric and Preventive Dentistry
Ghaziabad
UTTAR PRADESH |
9560509262
sakshi.jain7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS-CDSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with no systemic disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
940 nm diode laser |
Diode LASER (940nm) for cavity disinfection at 2 different power settings i.e 1 Watt and 2 Watt. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patient having atleast two cavitated occlusal dentinal caries
No relevant medical history
No clinical and radiographic signs of pulpal involvement
|
|
| ExclusionCriteria |
| Details |
Patients having pain in the tooth
Carious lesions involving pulp
Dental abscesses or fistulas in the procedure site
Children with systemic diseases, intellectual disability, psychiatric disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
LASER Disinfection at 1W: may lead to thermal changes and may bring about reduction in microbial count.
LASER Disinfection at 2W: may lead to greater thermal changes and may bring about greater reduction in microbial count.
|
1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post- Operative Pain/ Senstivity/ discomfort |
immediately after disinfection |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2019 |
| 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="0"
Months="0"
Days="30" |
|
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
|
This study is a randomized, parallel group,
active controlled trial that will be comparing the thermal changes and
anti-microbial efficacy of diode laser cavity disinfection at two different
power settings, i.e. 1Watt and 2Watt and will be conducted in 1 centre in
India. Primary outcome will be assessed for thermal changes and reduction in
microbial count before and after cavity disinfection with diode laser at 1W and
2W. |