Tokyo, Nov. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059756) titled 'Evaluation of the Effectiveness of Oral Hygiene Instruction Using an Intra oral Scanner' on Nov. 13.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Nagasaki University
Condition:
Condition - Periodontal disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate whether using IOS images of disclosed plaque for the Plaque Control Record (PCR) and oral hygiene instruction can improve plaque control.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral hygiene instruction using a hand mirror
Interventions/Control_2 - Oral hygiene instruction using an intraoral scanner
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Patients aged 18 years or older and under 90 years at the time of obtaining consent
Patients who have crowns in all of the following regions: maxillary anterior region, maxillary right and left posterior regions, mandibular anterior region, and mandibular right and left posterior regions.
Patients with a most recent PCR of 20% or higher
Patients who perform their own daily oral hygiene without assistance from a caregiver
Patients who have provided their own consent to participate in the study
Key exclusion criteria - Patients with limited finger movement due to conditions such as Parkinson's disease or cerebral infarction
Patients judged to lack decision-making capacity (including those with neuropsychiatric disorders)
Patients deemed inappropriate as study subjects by the principal investigator or co-investigators
Target Size - 36
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 25 Day
Date of IRB - 2025 Year 09 Month 30 Day
Anticipated trial start date - 2025 Year 11 Month 19 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068179
Disclaimer: Curated by HT Syndication.