| CTRI Number |
CTRI/2025/09/094240 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on the Effectiveness of Different Brushing techniques in school Children |
|
Scientific Title of Study
|
Comparitive evaluation on effectiveness of different tooth brushing techniques in reducing plaque and gingivitis among 6-9years old school children in Rajanagaram Mandal, Andhra Pradesh - a Randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Glory Srilekha Pithani |
| Designation |
post graduate |
| Affiliation |
lenora intitute of dental sciences |
| Address |
Department of public health dentistry lenora institute of dental sciences nh 16 near HP petrol pump Rajanagaram Rajahmundry
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
8309078387 |
| Fax |
|
| Email |
drglorysrilekha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Glory Srilekha Pithani |
| Designation |
post graduate |
| Affiliation |
lenora intitute of dental sciences |
| Address |
Department of public health dentistry lenora institute of dental sciences nh 16 near HP petrol pump Rajanagaram Rajahmundry
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
8309078387 |
| Fax |
|
| Email |
drglorysrilekha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Glory Srilekha Pithani |
| Designation |
post graduate |
| Affiliation |
lenora intitute of dental sciences |
| Address |
Department of public health dentistry lenora institute of dental sciences nh 16 near HP petrol pump Rajanagaram Rajahmundry
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
8309078387 |
| Fax |
|
| Email |
drglorysrilekha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Glory srilekha pithani |
| Address |
department of public health dentistry, Lenora institute of dental sciences, nh 16 near hp petrol pump, rajanagaram, rajahmundry,pincode: 533294. |
| 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 B Lakshmana Rao |
Lenora Institute of Dental Sciences |
Department of Public Health Dentistry, Lenora Institute of Dental Sciences, NH 16, near HP petrol pump, Rajanagaram Rajamundry.
East Godavari
ANDHRA PRADESH |
8832484492
08832484492
lidsrajahmundry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee LIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, (2) ICD-10 Condition: K036||Deposits [accretions] on teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Brushing Technique |
how the child normally brushes his/her teeth, no brushing technique is demonstrated, no oral hygiene instructions given. |
| Intervention |
Fones Brushing technique |
Fones brushing method is demonstrated using Dental
models and charts/ posters by Principle Investigator (PI), during initial examination and data is collected after 1 month and 3 months |
| Intervention |
Modified bass Brushing technique |
modified bass brushing method is demonstrated using Dental models and charts/ posters by Principle Investigator (PI) during initial examination and data is collected after 1 month and 3 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants who give informed/ Proxy consent.
2.Healthy children between the age group of 6-9 years.
3.Children who were willing and co-operative.
4.Children with Gingivitis.
5.Children belonging to government schools of
Rajanagaram mandal. |
|
| ExclusionCriteria |
| Details |
1.Children with special health care needs.
2.Children with oral infections.
3.Children with masochistic habits.
4.Children with Preventive orthodontic appliances. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
most effective Brushing technique for the
school going children in Rajanagaram |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
each group will be checked for any reduction in
plaque scores and gingival improvement post
intervention |
1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "480"
Final Enrollment numbers achieved (India)="480" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
31/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
This is a randomized, single blind, parallel group study evaluating the effectiveness in plaque removal and gingival improvement between the Fones, modified Bass and Conventional toothbrushing methods in 6 to 9 year-old children of Rajanagaram Mandal, Andhra Pradesh, India. Data is recorded at base line and post intervention at 1month and 3 months. |