Evaluation of the Effectiveness of Different Toothbrushes in Children

Not Applicable

Recruiting

• Conditions: Plaque, Dental; Gingivitis; Dental Plaque; Oral Hygiene; Periodontal Indexes
• Interventions: Device: standart manual toothbrush; Device: 360 degree toothbrush

• Registration Number: NCT06164496
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study Start: 2023-11-20
• Status Verified: 2023-12
• Study First Submitted: 2023-12-02
• Study First Submitted QC: 2023-12-02
• Study First Posted: 2023-12-11
• Last Update Submitted: 2023-12-15
• Primary Completion: 2023-12-20
• Last Update Posted: 2023-12-21
• Study Completion: 2024-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	standart manual toothbrush	A control group will be formed using a manual brush with a classic head.
study group	360 degree toothbrush	A study group will be formed using a 360-degree bristle brush.

Primary Outcome Measures

Name	Time	Method
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal	2 weeks	Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Maltepe, İstanbul, Turkey