Evaluation of the Effectiveness of Different Toothbrushes in Children

NCT06164496 | Unknown

• 1 other identifier: 27.11.2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control group

EXPERIMENTAL

A control group will be formed using a manual brush with a classic head.

Device: standart manual toothbrush

study group

EXPERIMENTAL

A study group will be formed using a 360-degree bristle brush.

Device: 360 degree toothbrush

Interventions

standart manual toothbrush DEVICE

Device on plaque removal efficacy

control group

360 degree toothbrush DEVICE

Device on plaque removal efficacy

study group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Maltepe, Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The dental investigator who performed the oral health assessment for dentition status and plaque status was blinded during the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single blinded randomized control trial

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 11, 2023
• Study Start: November 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: January 20, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)