| CTRI Number |
CTRI/2023/02/049789 [Registered on: 16/02/2023] Trial Registered Prospectively |
| Last Modified On: |
27/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Tooth brush effects on Gingival health and oral hygiene.
|
|
Scientific Title of Study
|
Effectiveness of Artificial Intelligence(AI) based tooth brush on Gingival health and oral hygiene.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gyanendra Kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Institute of Dental Sciences, New Delhi |
| Address |
Department of pediatric and preventive dentistry Fifth floor Maulana Azad institute of Dental Sciences New Delhi
Central
DELHI
110002
India |
| Phone |
9654700978 |
| Fax |
|
| Email |
gyanendrasaroj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyanendra Kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Institute of Dental Sciences, New Delhi |
| Address |
Department of pediatric and preventive dentistry Fifth floor Maulana Azad institute of Dental Sciences New Delhi
Central
DELHI
110002
India |
| Phone |
9654700978 |
| Fax |
|
| Email |
gyanendrasaroj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyanendra Kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Institute of Dental Sciences, New Delhi |
| Address |
Department of pediatric and preventive dentistry Fifth floor Maulana Azad institute of Dental Sciences New Delhi
Central
DELHI
110002
India |
| Phone |
9654700978 |
| Fax |
|
| Email |
gyanendrasaroj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Metcalfe House, Grand Trunk Rd, P&T Colony, Civil Lines, Defence Research Development Organization, New Delhi 110054 |
|
|
Primary Sponsor
|
| Name |
Defence Research Development Organization |
| Address |
DRDO Bhawan Raja ji Marg New Delhi 110011 |
| Type of Sponsor |
Government funding agency |
|
|
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 Gyanendra Kumar |
Maulana Azad Institute of Dental Sciences |
Department of Pediatric Dentistry and Department of Periodontology
New Delhi
DELHI |
9654700978
gyanendrasaroj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AI based tooth brushing |
Effectiveness of Artificial Intelligence based tooth brush is compared with manual conventional tooth brush in children and adults. All will be instructed to brush Twice daily for 2 minutes. Evaluation will be done at every 3 months.
The duration of study will be 3 years. |
| Comparator Agent |
Manual tooth brush |
All patients will be instructed to brush twice daily for 2 minutes. Effectiveness is compared over the period of 3 years. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
a.Parental consent for those below 18 years and subject consent for those above 18 years
b.Age group of 07-22 years
c.Subjects who are cooperative
d.Subjects with gingivitis (mild, moderate or severe)
e.Subjects with Oral Hygiene Index Score of >1.3
f.Subjects with PI of > 1
|
|
| ExclusionCriteria |
| Details |
a.Subjects who are not willing to take part in the research project
b.Uncooperative subjects
c.Subjects with Periodontitis
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival health and oral hygiene of the children, adults and special care need patients are evaluated and better effectiveness should be observed with Smart brushed |
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The application will be developed which will be compatible with iOS, android and windows, and fabricate a Bluetooth enabled chip based smart toothbrush will be useful in effectiveness of gingival health and oral hygiene of the children, adults and special care need patients. |
6 months
9 months |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
The present study aimed at effectiveness of Artificial Intelligence(AI) based tooth brush on Gingival health and oral hygiene. the objectives are; The first objective of this proposed project is to
develop an application compatible with iOS, android and windows, and fabricate
a Bluetooth enabled chip based smart toothbrush. To check and compare the effectiveness of AI Based
tooth brush with conventional tooth brush on gingival health and oral hygiene |