NCT07196969

Effects of Electric Toothbrushes on Periodontal Health and Oral Microbial Flora in Children With Space Maintainers

Effects of Electric and Manual Toothbrushes on Periodontal Health and Oral Microbial Flora in Children With Space Maintainers: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Pamukkale University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

Objectives: To evaluate and compare the effects of electric and manual toothbrushes on periodontal health parameters and salivary microbial flora in children with fixed and removable space maintainers. Materials and methods: Sixty-eight children (30 girls, 38 boys; mean age 8.8 years) requiring fixed (n=34) or removable (n=34) space maintainers were randomly allocated to electric (n=17) or manual (n=17) toothbrush subgroups. Periodontal indices; plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD) and salivary levels of Streptococcus mutans and Lactobacillus were assessed at baseline (T0), 1 month (T1), and 3 months (T2).

Detailed description

A total of 68 patients (thirty girls and thirty-eight boys), aged between 6 and 12 years (mean age 8.8), who received either fixed or removable space maintainers due to premature loss of primary molar teeth, were included in the study. Patients were randomized into two groups based on the type of space maintainer: fixed (n = 34) or removable (n = 34). Each group was further subdivided according to the type of toothbrush used: manual or electric, resulting in four subgroups (n=17). To standardize the study population, only band-and-loop appliances were used in the fixed space maintainer group, which were cemented using a fluoride-releasing glass ionomer cement (RelyX; 3M ESPE, St. Paul, MN, USA). Removable space maintainers consisted of an acrylic base with retention elements such as Adams' clasps, C clasps, or vestibular archesPatients in the removable space maintainer group were instructed to use their appliances during the day, except while eating and sleeping, and to clean them by brushing after toothbrushing.

Conditions

• Periodontal Parameters
• Oral Microbial Colonization
• Periodontal Health

Interventions

Type	Name	Description
DEVICE	Electric toothbrush	Two minutes; twice a day; 3-months.
DEVICE	Manual toothbrush	Two minutes; twice a day; 3-months.

Timeline

• Start date: 2022-07-18
• Primary completion: 2023-04-26
• Completion: 2023-04-26
• First posted: 2025-09-29
• Last updated: 2025-09-29

Locations

1 site across 1 country: Turkey (Türkiye)