Evaluation of the Effectiveness of Different Toothbrushes in Children

Gingivitis Clinical Trial

Official title:

Evaluating the Effectiveness of Different Toothbrushes in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164496
• Other study ID #: 27.11.2023
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: January 20, 2024

Study information

• Verified date: December 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis
• Oral Hygiene
• Plaque, Dental

Intervention

Device:
• standart manual toothbrush
Device on plaque removal efficacy
• 360 degree toothbrush
Device on plaque removal efficacy

Locations

Country	Name	City	State
Turkey	Marmara University	Maltepe	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal	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.	2 weeks