- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06541743
Efficacy of Regular, Musical and Electric Toothbrushes in Plaque Removal in Children
Efficacy of Regular, Musical and Electric Toothbrushes in Plaque Removal in Children - A Randomized Clinical Trial
Tooth brushing is essential for maintaining oral hygiene, especially in children, who are at a critical stage for developing lifelong oral health habits. Establishing effective tooth brushing behaviors for school-aged children (6-12 years) is vital for long-term dental health. Consistent and effective tooth brushing is crucial for reducing supragingival plaque, which is key to preventing periodontal diseases and ensuring good oral hygiene. Despite the availability of various plaque control methods, tooth brushing remains the most effective and safest approach.
However, young children, particularly those under ten, often struggle with the dexterity and motivation needed for proper tooth brushing, resulting in inadequate plaque removal. Manual tooth brushing, though effective, can become monotonous and fail to engage children, making it difficult to establish regular brushing habits. Studies have shown that regular removal of supragingival plaque can significantly reduce both supra- and subgingival pathogenic species, underscoring the importance of effective plaque control.
Innovative solutions such as electric and musical toothbrushes have been developed to address these challenges.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Electric toothbrushes enhance plaque removal through mechanical action, while musical toothbrushes aim to boost motivation and compliance by incorporating interactive elements like music and colorful designs. Musical toothbrushes play music for two minutes, encouraging children to brush for the recommended duration and making the activity more enjoyable. Previous research has shown varying levels of success with these advanced toothbrushes. For example, one of the recent study have found that musical toothbrushes significantly improved plaque control compared to regular ones. Similarly, other studies have reported substantial plaque reduction with musical toothbrushes. Furthermore, it has been observed that while both manual and powered toothbrushes improved clinical parameters, powered toothbrushes had a more significant impact on gingival health.
Despite these promising results, there is a lack of comprehensive comparative studies on the efficacy of regular, electric, and musical toothbrushes in children. This study aimed to address this gap by conducting a randomized clinical trial to evaluate and compare the effectiveness of these three types of toothbrushes in removing supragingival plaque in children aged 6-12 years.
To the best of our knowledge, this is the first clinical study wherein the comparisons had been made between regular, musical and electric toothbrushes. The findings will provide valuable insights into the most effective tools for promoting oral hygiene in children, potentially shaping future recommendations and practices in pediatric dentistry.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Al-Jouf
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Sakaka, Al-Jouf, Saudi Arabia, 75432
- College of Dentistry, Jouf University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Regular Toothbrush
Oral-B Chhota Bheem Toothbrush.
|
Participants and their guardians will be 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 will also provided.
Guardians will be supervised brushing to ensure compliance and prevent the use of other oral hygiene measures.
|
|
Active Comparator: Musical Toothbrush
Aqua White Musical Chhota Bheem Toothbrush.
|
Participants and their guardians will be 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 will also provided.
Guardians will be supervised brushing to ensure compliance and prevent the use of other oral hygiene measures.
|
|
Active Comparator: Electric Toothbrush
Oral-B Star Wars Kids Electric Toothbrush.
|
Participants and their guardians will be 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 will also provided.
Guardians will be supervised brushing to ensure compliance and prevent the use of other oral hygiene measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque Index (Quigley and Hein)
Time Frame: 45 days
|
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. Quigley-Hain plaque index 0 No plaque 1 Isolated flecks of plaque at the gingival margin 2 A continuous band of plaque up to 1mm at the gingival margin 3 Plaque greater than 1mm in width and covering up to one third of the tooth surface 4 Plaque covering from one thirds to two thirds of the tooth surface 5 Plaque covering more than two thirds of the tooth surface |
45 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Namdeo Prabhu, MDS, College of Dentistry, Jouf University
Publications and helpful links
General Publications
- Kitsaras G, Goodwin M, Kelly MP, Pretty IA. Bedtime Oral Hygiene Behaviours, Dietary Habits and Children's Dental Health. Children (Basel). 2021 May 19;8(5):416. doi: 10.3390/children8050416.
- Axe A, Mueller WD, Rafferty H, Lang T, Gaengler P. Impact of manual toothbrush design on plaque removal efficacy. BMC Oral Health. 2023 Oct 25;23(1):796. doi: 10.1186/s12903-023-03518-6.
- Feres M, Gursky LC, Faveri M, Tsuzuki CO, Figueiredo LC. Clinical and microbiological benefits of strict supragingival plaque control as part of the active phase of periodontal therapy. J Clin Periodontol. 2009 Oct;36(10):857-67. doi: 10.1111/j.1600-051X.2009.01471.x. Epub 2009 Aug 23.
- Mateu FA, Boneta AE, DeVizio W, Stewart B, Proskin HM. A clinical investigation of the efficacy of two dentifrices for controlling established supragingival plaque and gingivitis. J Clin Dent. 2008;19(3):85-94.
- 5. Liu L. The impact of innovation of electric toothbrush. 2022. https://doi.org/10.2991/aebmr.k.220307.295
- Prendergast V, Chapple KM. Evaluation and Acceptance of an Electric Toothbrush Designed for Dependent Patients. Cureus. 2021 Jun 1;13(6):e15372. doi: 10.7759/cureus.15372. eCollection 2021 Jun.
- Lee J, Park HM, Kim YW. Comparative Analysis of Plaque Removal and Wear between Electric-Mechanical and Bioelectric Toothbrushes. Bioengineering (Basel). 2024 May 9;11(5):474. doi: 10.3390/bioengineering11050474.
- Vargas CM, Arevalo O. How dental care can preserve and improve oral health. Dent Clin North Am. 2009 Jul;53(3):399-420. doi: 10.1016/j.cden.2009.03.011.
- Ganesh M, Shah S, Parikh D, Choudhary P, Bhaskar V. The effectiveness of a musical toothbrush for dental plaque removal: a comparative study. J Indian Soc Pedod Prev Dent. 2012 Apr-Jun;30(2):139-45. doi: 10.4103/0970-4388.99988.
- 10. Pillay R, Mathur A, Jain M, Singh A, Gupta V. Comparative efficacy of musical and regular toothbrush in children. Int J Curr Res Rev. 2021;13(14):142-7.
- Subburaman N, Madan Kumar PD, Iyer K. Effectiveness of musical toothbrush on oral debris and gingival bleeding among 6-10-year-old children: A randomized controlled trial. Indian J Dent Res. 2019 Mar-Apr;30(2):196-199. doi: 10.4103/ijdr.IJDR_128_17.
- Haffajee AD, Thompson M, Torresyap G, Guerrero D, Socransky SS. Efficacy of manual and powered toothbrushes (I). Effect on clinical parameters. J Clin Periodontol. 2001 Oct;28(10):937-46. doi: 10.1034/j.1600-051x.2001.028010937.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- (DGSSR-2023-01-02524)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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