| CTRI Number |
CTRI/2022/10/046161 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
30/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of a musical tooth brushing drill. |
|
Scientific Title of Study
|
Efficacy of a musical tooth brushing drill in maintenance of oral hygiene among children at a correctional institute in Bengaluru city |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SAFIA RAHMAN |
| Designation |
Post Graduate Student |
| Affiliation |
BANGALORE INSTITUE OF DENTAL SCIENCES |
| Address |
Department of Public Health Dentistry
Bangalore Institute of Dental Sciences
5/3 Hosur Main Road, Lakkasandra Extension, Wilson Garden
Bangalore
KARNATAKA
560027
India |
| Phone |
|
| Fax |
|
| Email |
saf.rehman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanishree N |
| Designation |
Professor and Head of the Department |
| Affiliation |
BANGALORE INSTITUE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTISTY
BANGALORE INSTITUTE OF DENTAL SCIENCES
5/3 HOSUR MAIN ROAD LAKKASANDARA EXTENSION WILSON GARDEN BENGALURU
Bangalore
KARNATAKA
560027
India |
| Phone |
|
| Fax |
|
| Email |
dr.vanishree06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SAFIA RAHMAN |
| Designation |
Post Graduate Student |
| Affiliation |
BANGALORE INSTITUE OF DENTAL SCIENCES |
| Address |
Department of Public Health Dentistry
Bangalore Institute of Dental Sciences
5/3 Hosur Main Road
Lakkasandra Extension, Wilson Garden
Bangalore
KARNATAKA
560027
India |
| Phone |
|
| Fax |
|
| Email |
saf.rehman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry,
BANGALORE INSTITUTE OF DENTAL SCIENCES,
5/3 HOSUR MAIN ROAD, LAKKASANDRA EXTENSION, WILSON GARDEN, BENGALURU 560027 |
|
|
Primary Sponsor
|
| Name |
DrSafia Rahman |
| Address |
Department of Public Health Dentistry
BANGALORE INSTITUTE OF DENTAL SCIENCES
5/3 HOSUR MAIN ROAD LAKKASANDRA EXTENSION WILSON GARDEN BENGALURU 560027 |
| 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 Vanishree N |
Correctional Institute for children |
Room no. 3 Dental Clinic
Dr. H Marigowda Road, Hosur MAin Road
Bangalore
KARNATAKA |
9880030208
dr.vanishree06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| District Child Protection Unit, Bangalore Urban |
No Objection Certificate |
| Institutional Ethical Clearance Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral hygiene status |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MUSICAL TOOTH BRUSHING DRILL |
music is played and the children are taught how to brush their teeth everyday for 15 days. |
| Comparator Agent |
Regular tooth brushing |
Control group not subjected to the musical drill for 15 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged between 12-15years
2.Subjects with ability to follow instructions
|
|
| ExclusionCriteria |
| Details |
1.Participants with poor manual dexterity
2.Differently abled children who require special assistance for brushing
3.Those participants with any systemic and acute illness and under medication.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| aim of this study is to assess the efficacy of a musical tooth brushing drill in the oral hygiene status of the children using Turkish Modification of Quigley-Hein Plaque index. |
assessment of oral hygiene status of the children at 0, 15 and 30th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compliance to the brushing drill |
at end of 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2022 |
| Date of Study Completion (India) |
05/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
rahman s. et al. efficacy of musical tooth brushing drill in maintenance of oral hygiene among children at a correctional institute in Bengaluru City J Dent Res Pract,2023,5(2), 001-004 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [saf.rehman@gmail.com].
- For how long will this data be available start date provided 26-09-2022 and end date provided 26-08-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Tooth brushes are more for play than actual brushing. Motivating these children to brush their teeth becomes imperative. Dental health education using music, dance and songs can provide a deeper message and provide a better learning experience for these children. Hence the aim of this study is to assess the efficacy of a musical tooth brushing drill in the oral hygiene status of the children. Plaque will be assessed on the labial, buccal, and lingual surfaces of all the teeth after using DPI AlphaPlac Two Tone Disclosing Agent Dye. It is a two colour disclosing solution to locate old plaque (stained blue) and new plaque (stained pink). The scores given 0: No plaque; 1: Separate flecks of plaque at the cervical margin of the tooth; 2: A thin continuous band of plaque (up to 1 mm) at the cervical margin; 3: A band of plaque wider than 1 mm but coverÂing less than one-third of crown of the tooth; 4: Plaque covering at least one-third but less than two-thirds of the crown; 5: Plaque covering two-thirds or more of the crown. The participants will be subjected to a music and action routine for tooth brushing. Repetitive exercise for two weeks will be done to condition the participants. Plaque scores will be assessed using a disclosing agent at baseline, at the end of two-week training drill and four-week follow-up where the participants were asked to brush by themselves without any supervision. |