Clinical trial NCT06541743: Efficacy of Regular, Musical and Electric Toothbrushes in Plaque Removal in Children
Official title: Efficacy of Regular, Musical and Electric Toothbrushes in Plaque Removal in Children - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children, Adult
Plaque
Keywords: Children
Oral Health
Toothbrush
Plaque Removal
Lead sponsor: Jouf University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 111
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * (Regular Toothbrush): Oral-B Chhota Bheem Toothbrush.
* (Musical Toothbrush): Aqua White Musical Chhota Bheem Toothbrush.
* (Electric Toothbrush): Oral-B Star Wars Kids Electric Toothbrush
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plaque Index (Quigley and Hein)
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sakaka
country: Saudi Arabia
facility: College of Dentistry, Jouf University
state: Al-Jouf
Study officials:
affiliation: College of Dentistry, Jouf University
name: Namdeo Prabhu, MDS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 5. Liu L. The impact of innovation of electric toothbrush. 2022. https://doi.org/10.2991/aebmr.k.220307.295
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.