| CTRI Number |
CTRI/2024/09/073983 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of laser light on the bacterial count on the teeth of 4 to 6years children |
|
Scientific Title of Study
|
Antimicrobial Efficacy of 810nm Diode Laser on S. Mutans in Caries Susceptible Children of age 4-6 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mandala Pravallika |
| Designation |
MDS Post Graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Pedodontics and Preventive Dentistry room no 5 2nd floor block 3 Vishnu dental college Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9491617684 |
| Fax |
|
| Email |
pravallika.m@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ahalya Penemtsa |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Pedodontics and Preventive Dentistry room no 5 2nd floor block 3 Vishnu dental college Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9010427724 |
| Fax |
|
| Email |
ahalya.p@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ahalya Penemtsa |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Pedodontics and Preventive Dentistry room no 5 2nd floor block 3 Vishnu dental college Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9010427724 |
| Fax |
|
| Email |
ahalya.p@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College Vishnupur Bhimavaram West Godavari Andhra Pradesh India 534202 |
|
|
Primary Sponsor
|
| Name |
Dr Pravallika M |
| Address |
Postgraduate Department of Pedodontics and Preventive Dentistry room no 5 2nd floor block 3 Vishnu Dental College Vishnupur Bhimavaram West Godavari Andhra Pradesh India 534202 |
| 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 Pravallika |
Vishnu Dental College |
Department of Pedodontics and Preventive Dentistry Room no 5 2nd floor Vishnu Dental College Vishnupur Bhimavaram 534202
West Godavari
ANDHRA PRADESH |
9491617684
pravallika.m@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Double irradiation with 810nm diode laser |
810nm diode laser will be irradiated on the teeth for a duration of 30 seconds with a power of 0.2 watts in 2 appointments.
Indocyanine green photosensitizer will be applied on the tooth surface and then double irradiation will be done on 0th and 3rd day respectively |
| Comparator Agent |
Single irradiation with 810nm diode laser |
810nm diode laser will be irradiated on the teeth for a duration of 30 seconds with a power of 0.2 watts in single appointment.
Indocyanine green photosensitizer will be applied on the tooth surface and then double irradiation will be done on 0th day.
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1)urban population of low socioeconomic class
2)Improper brushing habits
3)Plaque scores- 2&3
4)Sweet scores: 10 & 15
5)S. mutans microbial count of 100000CFU/ml
6)salivary pH of less than 5.5
7)stimulated salivary flow rate of 0.7ml/min
8)unstimulated salivary flow rate of 0.3ml/min
9)salivary viscosity mucous
|
|
| ExclusionCriteria |
| Details |
1.Children with systemic disorder
2.Children with low plaque scores
3.Children who had undergone prophylaxis procedures in last few weeks
4.Children who are under medication (antibiotics) in last two weeks / 1month
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of S. mutans count in plaque and saliva using single and double irradiation by Antimicrobial Photodynamic Therapy |
1)single irradiation group - Baseline, 0 min, 24 hours, 7th day and 14th day
2)double irradiation groups - Baseline, 0 min, 24 hours,3rd day, 7th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| b)Caries incidence is evaluated at 3 & 6 months using Nyvad’s criteria. |
at 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
21/09/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study involves the use of a diode laser and photosensitizer to observe the decrease in S.mutans CFU in plaque and saliva after single and double irradiation in 4- 6 years children, where aPDT effect will be observed in both single and double irradiation with and without photosensitizer. Plaque and salivary samples will be collected and transferred to agar media and their CFU will be counted. 1st visit – pre-operative samples ( plaque and saliva) will be taken for all groups & immediate post-operative samples will be collected after being subjected to respective light therapy protocols in all the groups. 2nd visit – after 24 hours, post-operative samples will be collected in all groups. 3rd visit –In double irradiation groups (groups -3,4) on the 3rd day pre-operative & immediate post-operative plaque samples will be collected after the 2nd dose of light therapy. 4th visit – After 1 week, post-operative plaque samples and salivary samples will be collected in all groups. 5th visit – After 2 weeks, post-operative plaque samples and salivary samples will be collected in all groups. 6th & 7th visits - recording of the caries incidence at 3 & 6 months |