| CTRI Number |
CTRI/2025/02/080966 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two toothpaste in blind children |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Effects Using various flavored toothpaste in visually impaired children with gingivitis- a Randomized control trial |
| 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 Yadlapalli Vineela Chowdary |
| Designation |
Postgraduate student |
| Affiliation |
AMEs Dental College and Hospital |
| Address |
AMEs Dental College and Hospital, Road, near Govt. Polytechnic College, Ashok Nagar, Bijangera, Raichur, Karnataka 584103
Phone: 085322 40718
Raichur
KARNATAKA
584103
India |
| Phone |
8317674174 |
| Fax |
|
| Email |
vineelachowdary8525@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrutha S P |
| Designation |
Professor |
| Affiliation |
AMEs Dental College and Hospital |
| Address |
AMEs Dental College and Hospital, Road, near Govt. Polytechnic College, Ashok Nagar, Bijangera, Raichur, Karnataka 584103
Phone: 085322 40718
Raichur
KARNATAKA
584103
India |
| Phone |
8317674714 |
| Fax |
|
| Email |
shruthavinit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrutha S P |
| Designation |
Professor |
| Affiliation |
AMEs Dental College and Hospital |
| Address |
AMEs Dental College and Hospital, Road, near Govt. Polytechnic College, Ashok Nagar, Bijangera, Raichur, Karnataka 584103
Phone: 085322 40718
Raichur
KARNATAKA
584103
India |
| Phone |
8317674714 |
| Fax |
|
| Email |
shruthavinit@gmail.com |
|
|
Source of Monetary or Material Support
|
| AME Dental College and Hospital, Raichur, Karnataka, India 584103 |
|
|
Primary Sponsor
|
| Name |
Dr Yadlapalli Vineela Chowdary |
| Address |
AME dental college
Bijangera road
Raichur 584103 |
| 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 |
| Vineela Chowdary |
AME Dental College Raichur |
room no 4 department
of pedodontics AMEs
Dental college and
Hospital bijingera road
Raichur Raichur
KARNATAKA
Raichur
KARNATAKA
Raichur
KARNATAKA |
9483329406
vineelachowdary8525@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for AME denatl college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flavored toothpaste |
Commercially available Flavored toothpaste is given and gingival index is recorded at one month and three-month intervals. so total duration is three months. |
| Comparator Agent |
Unflavored toothpaste |
Commercially available unflavored toothpaste and gingival index is recorded at one month and three-month intervals. so total duration is three months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
All visually impaired children without any other medical risks |
|
| ExclusionCriteria |
| Details |
medically compromised children |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of flavored toothpaste on oral hygiene status of visually impaired children |
Preoperative, 27 days, Postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of unflavored toothpaste on oral hygiene status of visually impaired children |
Preoperative, 27 days, Postoperative |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| Date of Study Completion (India) |
21/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
To compare the effect of flavored and unflavored toothpaste on oral hygiene status of visually impaired children and use of different taste and aroma of the toothpaste in enhancing oral hygiene. Gingival index is recorded at one month and three-month intervals. |