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Evaluation of the Effectiveness of Different Toothbrushes in Children

Evaluating the Effectiveness of Different Toothbrushes in Children

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06164496
Enrollment
120
Registered
2023-12-11
Start date
2023-11-20
Completion date
2024-01-20
Last updated
2023-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Plaque, Gingivitis, Oral Hygiene, Periodontal Indexes, Plaque, Dental

Brief summary

Control groups will be formed in the 2-12 age group using standard manual toothbrushes, and the effectiveness of 360-degree bristle toothbrushes will be compared. Study design: Experimental study

Detailed description

In this randomized controlled, single-brushing study, children were assigned to a treatment sequence involving a 360-degree toothbrush and a control brush. Subjects were randomly assigned to a treatment sequence involving a 360-degree toothbrush and a classical manual control toothbrush. Parents brushed the teeth of their children aged 2-5 years, whereas children aged 6-12 years brushed their own teeth under the supervision of clinic staff, unaided by a mirror. Clinical examination of each participant was carried out by the principal investigator. Assessments were done pre- and post-brushing using the Silness and Löe Plaque Index (PI), Gingival Index (GI), and the Simplified Oral Hygiene Index (OHI-S). Plaque indices were expressed as means and standard deviations (SD). Within each toothbrush group, the follow-up scores were analyzed using a paired t-test. p \< 0.05 was considered statistically significant.

Interventions

DEVICEstandart manual toothbrush

Device on plaque removal efficacy

DEVICE360 degree toothbrush

Device on plaque removal efficacy

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

The dental investigator who performed the oral health assessment for dentition status and plaque status was blinded during the intervention.

Intervention model description

single blinded randomized control trial

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy children aged 2-12. * Children without systemic disease or developmental dental anomalies. * Children not undergoing orthodontic treatment. * Children with no decay on the labial surfaces of upper anterior incisors. * Patients or their parents accepting participation in the treatment.

Exclusion criteria

* Children with decay on the labial surfaces of upper anterior incisors. * Children undergoing orthodontic treatment. * Children who, along with their parents, do not agree to participate in the treatment will be excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal2 weeksMean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026