Tokyo, Sept. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059049) titled 'Analysis of the Effectiveness of a Plaque Detecting Toothbrush' on Sept. 11.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Institute of SCIENCE TOKYO
Condition:
Condition - gingivitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Dental caries is a prevalent disease during school age. For the prevention of dental caries, the acquisition of appropriate toothbrushing techniques and the enhancement of awareness regarding oral care are essential. The significance of this study lies in clarifying the effectiveness of a plaque-detecting toothbrush in reducing residual plaque and demonstrating its usefulness in supporting self-care at home. Furthermore, this study aims to provide practical insights that can be applied in clinical dentistry and preventive care.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The plaque-detecting toothbrush will be provided to participating parent-child pairs, who will use it at home as part of their routine toothbrushing. The intervention period will last 2-3 weeks, after which evaluations will be conducted at the follow-up visit.
Eligibility:
Age-lower limit - 6
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Parent-child pairs consisting of elementary school children (ages 6-12) attending the dental clinics cooperating in this study and their guardians, who have received an explanation of the study and provided written informed consent.
Key exclusion criteria - Individuals who cannot accept the use of an electric toothbrush; those engaged in the dental profession; those with severe systemic diseases (e.g., cardiac disease, acute illness, abnormal blood pressure, malignancy, febrile illness, infectious disease, hemophilia, diabetes, liver disease, etc.); those who are pregnant or possibly pregnant; those on long-term prescription medications from a hospital; those undergoing orthodontic treatment with wire-based appliances (non-wire types are acceptable); those whose dental crowns or restorations are entirely provided under private treatment; and those using dentures, partial dentures, bridges, or implants.
Target Size - 72
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 09 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2026 Year 03 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067529
Disclaimer: Curated by HT Syndication.