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

P

Pamukkale University

Status

Completed

Conditions

Oral Microbial Colonization
Periodontal Parameters
Periodontal Health

Treatments

Device: Manual toothbrush
Device: Electric toothbrush

Study type

Interventional

Funder types

Other

Identifiers

NCT07196969
2022DİŞF002

Details and patient eligibility

About

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).

Full 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.

Enrollment

84 patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children aged 6-12 years who required a space maintainer due to premature loss of primary molar teeth were included if they were medically healthy; had no periodontal disease, temporomandibular disorders, bruxism, abnormal oral habits, or physical/mental disabilities affecting hand movement; were not on regular medication; had not used antibiotics within the past three months or plaque-preventive agents within the last six months; and were able to comply with scheduled follow-up visits.

Exclusion criteria

  • Patients who failed to attend follow-up appointments or developed an infection/disease requiring antibiotic therapy during the study were excluded.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 4 patient groups

Group I: Fixed Space Maintainer with Manual Toothbrush
Other group
Description:
In this group, patients with fixed space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter \& Gamble, USA) during study period.
Treatment:
Device: Manual toothbrush
Group II: Fixed Space Maintainer with Electric Toothbrush
Experimental group
Description:
In this group, patients with fixed space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter \& Gamble, USA) during study period.
Treatment:
Device: Electric toothbrush
Group III: Removable Space Maintainer with Manual Toothbrush
Other group
Description:
In this group, patients with removable space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter \& Gamble, USA) during study period.
Treatment:
Device: Manual toothbrush
Group IV: Removable Space Maintainer with Electric Toothbrush
Experimental group
Description:
In this group, patients with removable space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter \& Gamble, USA) during study period.
Treatment:
Device: Electric toothbrush

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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