Efficacy of Regular, Musical and Electric Toothbrushes in Plaque Removal in Children

NCT06541743 | Completed DMC

• 1 other identifier: (DGSSR-2023-01-02524)
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Children, Adult; Plaque

Keywords

Children; Oral Health; Toothbrush; Plaque Removal

Outcome Measures

Primary Outcomes (1)

• 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. 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

Study Arms (3)

Regular Toothbrush

ACTIVE COMPARATOR

Oral-B Chhota Bheem Toothbrush.

Device: Regular Toothbrush

Musical Toothbrush

ACTIVE COMPARATOR

Aqua White Musical Chhota Bheem Toothbrush.

Device: Musical toothbrush

Electric Toothbrush

ACTIVE COMPARATOR

Oral-B Star Wars Kids Electric Toothbrush.

Device: Electric toothbrush

Interventions

Regular Toothbrush DEVICE

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.

Regular Toothbrush

Musical toothbrush DEVICE

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.

Musical Toothbrush

Electric toothbrush DEVICE

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.

Electric Toothbrush

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-12 years;
• Cooperative children; and
• Children with a minimum of twenty teeth

You may not qualify if:

• Children with poor oral hygiene characterized by extrinsic stains or calculus deposits;
• Presence of any oral lesions;
• Presence of malocclusion; and
• Medically compromised patients

Sponsors & Collaborators

• Jouf University: lead

Study Sites (1)

College of Dentistry, Jouf University

Sakakah, Al Jawf Region, 75432, Saudi Arabia

Location

Related Publications (12)

• 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.

  PMID: 34069504 BACKGROUND

• 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.

  PMID: 37880662 BACKGROUND

• 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.

  PMID: 19703236 BACKGROUND

• 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.

  PMID: 19301514 BACKGROUND

• 5. Liu L. The impact of innovation of electric toothbrush. 2022. https://doi.org/10.2991/aebmr.k.220307.295

  BACKGROUND

• 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.

  PMID: 34249525 BACKGROUND

• 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.

  PMID: 38790341 BACKGROUND

• 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.

  PMID: 19482119 BACKGROUND

• 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.

  PMID: 22918099 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31169149 BACKGROUND

• 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.

  PMID: 11686812 BACKGROUND

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Namdeo Prabhu, MDS

  College of Dentistry, Jouf University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: * (Regular Toothbrush): Oral-B Chhota Bheem Toothbrush. * (Musical Toothbrush): Aqua White Musical Chhota Bheem Toothbrush. * (Electric Toothbrush): Oral-B Star Wars Kids Electric Toothbrush

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 7, 2024
• Study Start: January 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)