Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059129) titled 'Efficacy test of the dentifrice' on Sept. 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kanagawa Dental University
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the oral benefits of continuous use of dentifrice NW372.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Use dentifrice NW372 at least twice a day for 6 months
Interventions/Control_2 - Use control dentifrice at least twice a day for 6 months.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Males and females aged 18 to 79 years.
2.Patients receiving regular dental check-ups at Kanagawa Dental University Hospital and staff members of Kanagawa Dental University Hospital.
3.Subjects with gingival recession without inflammation in the maxillary and mandibular central incisors and lateral incisors, exhibiting minimal dental misalignment.
4.Subjects who can use toothpaste in amounts of at least 1 gram and brush their teeth for a minimum of 2 minutes, twice a day.
5.Subjects who agree to use only the specified toothpaste and toothbrush during the trial period (interdental brushes and dental floss are allowed, but the use of other toothpastes, mouthwashes, and liquid toothpastes is not permitted).
6.Subjects with no smoking habits.
7.Subjects who can discontinue high-concentration fluoride applications during the trial period.
Key exclusion criteria - 1.Subjects with implants, dentures (false teeth), crowns, fillings near the gingival margin, or root surface caries on the target teeth.
2.Subjects who have undergone periodontal regenerative treatment within the past 6 months.
3.Subjects with smoking habits.
4.Subjects who are already participating in other research at the time of receiving an explanation of the research, or who are scheduled to participate in other research during the period of cooperation for participation in this study.
5.Subjects deemed ineligible based on the diagnosis of a dentist.
6.Subjects who are deemed inappropriate for participation in the study by the principal investigator or research staff due to other reasons, including noncompliance with study obligations.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 20 Day
Date of IRB - 2025 Year 06 Month 09 Day
Anticipated trial start date - 2025 Year 09 Month 30 Day
Last follow-up date - 2026 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067640
Disclaimer: Curated by HT Syndication.