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Completed

NCT Number: NCT07196969

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

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).

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Key information

Conditions

Periodontal Parameters Oral Microbial Colonization Periodontal Health

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University Faculty of Dentistry

Denizli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electric toothbrush

Device

Two minutes; twice a day; 3-months.

Manual toothbrush

Device

Two minutes; twice a day; 3-months.

Primary outcomes

  1. Change in Plaque Index (PI)

    Time frame: Baseline (T0), 1 month (T1), and 3 months (T2).

    Evaluation of plaque index scores using the Modified Silness and Löe Index.

  2. Change in Gingival Index (GI)

    Time frame: Baseline (T0), 1 month (T1), and 3 months (T2)

    Evaluation of gingival index scores using the Gingival Index.

  3. Change in Bleeding on Probing (BOP)

    Time frame: Baseline (T0), 1 month (T1), and 3 months (T2)

    Evaluation of bleeding on probing scores using the Bleeding on Probing (bop) Index

  4. Change in Periodontal Pocket Depth (PPD)

    Time frame: Baseline (T0), 1 month (T1), and 3 months (T2)

    Evaluation of periodontal pocket depth (PPD)

  5. Change in salivary Streptococcus mutans levels

    Time frame: Baseline (T0), 1 month (T1), and 3 months (T2)

  6. Change in salivary Lactobacillus levels

    Time frame: Baseline (T0), 1 month (T1), and 3 months (T2)

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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