Efficacy of Regular, Musical and Electric Toothbrushes in Plaque Removal in Children - A Randomized Clinical Trial
Phase: NA
Conditions: Children, Adult, Plaque
Sponsor: Jouf University

Efficacy of regular, musical and electric toothbrushes in plaque removal in children –  
A randomized clinical trial 
DATED: 04/08/2024 
STUDY PROTOCOL 
Study design 
This study is designed as a randomized clinical trial to compare the efficacy of three types of 
toothbrushes - regular, musical, and electric - in removing supragingival plaque among children 
aged 6-12 years. The study duration was set for 2 months, beginning on January 15, 2024. 
Ethical approval 
Ethical approval (no. 07-06-43) was sought from the Local Committee of Bioethics at Jouf 
University, KSA. All necessary approvals were obtained prior to the initiation of the study to 
ensure ethical compliance and participant safety. 
Sample size calculation 
Sample size estimation was done by using GPower software (version 3.0). Sample size was 
estimated for F test and ANOVA: Repeated measures, between factors, for 3 groups and4follow 
up measurements was chosen. A minimum total sample size of 102 was found to be sufficient 
for an alpha of 0.05, power of 95%, 0.25 as effect size. As the proposed study is a trial of 60 
days duration with 4 repeated measurements, so keeping in mind a 10% attrition, the sample 
size was inflated to 111 (37 per group). 
Participant selection  
A total of 111 healthy children participated in the study, each selected based on specific 
inclusion and exclusion criteria. Written consent was obtained from the parents or guardians of 
all participants.  
Inclusion criteria 
• 
Children aged 6-12 years; 

• 
Cooperative children; and 
• 
Children with a minimum of twenty teeth. 
Exclusion criteria 
• 
Children with poor oral hygiene characterized by extrinsic stains or calculus deposits; 
• 
Presence of any oral lesions; 
• 
Presence of malocclusion; and 
• 
Medically compromised patients. 
Randomization and allocation 
Participants were randomly allocated to one of three groups (n = 37 participants per group) 
using a computer-generated randomization sequence managed by the first examiner. The 
groups are defined as follows: 
• 
Group 1 (Regular Toothbrush): Oral-B Chhota Bheem Toothbrush. 
• 
Group 2 (Musical Toothbrush): Aqua White Musical Chhota Bheem Toothbrush. 
• 
Group 3 (Electric Toothbrush): Oral-B Star Wars Kids Electric Toothbrush. 
Table 1 allocate steps for randomization of the process. 
Blinding 
To reduce bias, the second examiner, responsible for recording clinical parameters, was blinded 
to the group assignments. 
Intervention 
Participants and their guardians were instructed in the horizontal scrub technique and asked to 
adhere to a brushing regimen of two minutes, twice daily, for 45 days. Standard fluoride 
toothpaste and a diary for recording brushing experiences was also provided. Guardians 
supervised brushing to ensure compliance and prevent the use of other oral hygiene measures. 
Outcome measures 

The primary outcome measure is the Plaque Index (Quigley and Hein). Plaque assessments 
was conducted at baseline (day 0) and on days 15, 30, and 45. Participants were refrain from 
oral hygiene for 24 hours before each recall visit. During each visit, they were supposed to 
brush under supervision for two minutes with their assigned toothbrush and toothpaste. Plaque 
disclosure was achieved using a 5 mL disclosing solution for 15 seconds, followed by rinsing 
with 10 mL water for 10 seconds. 
Data collection 
All clinical data was recorded using a standardized proforma. The principal investigator 
ensured the accuracy and confidentiality of the data, entering it into a data sheet immediately 
after collection. Confidentiality was maintained by anonymizing survey responses and securely 
storing the data. 
Data management plan 
The data management plan includes continuous monitoring by the principal investigator, secure 
transfer and storage of data, and adherence to safety and ethical protocols.  
Potential risks and benefits 
The study presents minimal risks, mainly limited to potential discomfort from brushing or 
allergic reactions to toothpaste. However, the potential benefits include improved oral hygiene 
awareness and a reduction in plaque, contributing to better oral health outcomes for the 
participants. 
This detailed methodology ensures a clear, structured approach to conducting the trial, adhering 
to CONSORT13 guidelines for reporting randomized clinical trials. The study, self-funded, 
aimed to contribute valuable insights into paediatric dental care practices and enhance oral 
health education for parents and guardians, aligning with the goals of the CONSORT guidelines 
for transparent reporting of clinical trials.