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

NCT07196969 | Completed

• 1 other identifier: 2022DİŞF002
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Periodontal Parameters; Oral Microbial Colonization; Periodontal Health

Keywords

Electric toothbrush; Manual toothbrush; Periodontal health; Pediatric dentistry; Space maintainers; Salivary microbiota

Outcome Measures

Primary Outcomes (6)

• Change in Plaque Index (PI)

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

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

• Change in Gingival Index (GI)

  Evaluation of gingival index scores using the Gingival Index.

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

• Change in Bleeding on Probing (BOP)

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

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

• Change in Periodontal Pocket Depth (PPD)

  Evaluation of periodontal pocket depth (PPD)

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

• Change in salivary Streptococcus mutans levels

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

• Change in salivary Lactobacillus levels

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

Study Arms (4)

Group I: Fixed Space Maintainer with Manual Toothbrush

OTHER

In this group, patients with fixed space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter \& Gamble, USA) during study period.

Device: Manual toothbrush

Group II: Fixed Space Maintainer with Electric Toothbrush

EXPERIMENTAL

In this group, patients with fixed space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter \& Gamble, USA) during study period.

Device: Electric toothbrush

Group III: Removable Space Maintainer with Manual Toothbrush

OTHER

In this group, patients with removable space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter \& Gamble, USA) during study period.

Device: Manual toothbrush

Group IV: Removable Space Maintainer with Electric Toothbrush

EXPERIMENTAL

In this group, patients with removable space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter \& Gamble, USA) during study period.

Device: Electric toothbrush

Interventions

Electric toothbrush DEVICE

Two minutes; twice a day; 3-months.

Group II: Fixed Space Maintainer with Electric Toothbrush; Group IV: Removable Space Maintainer with Electric Toothbrush

Manual toothbrush DEVICE

Two minutes; twice a day; 3-months.

Group I: Fixed Space Maintainer with Manual Toothbrush; Group III: Removable Space Maintainer with Manual 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 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Dentistry

Denizli, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 29, 2025
• Study Start: July 18, 2022
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)