Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515483
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss in Controlling Gingivitis and Supragingival Plaque Removal During Thirty Days
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a single-blind single-center parallel randomized controlled clinical trial to evaluate the efficacy and safety of Floss Loops stretchable floss for the control of gingivitis and supragingival plaque removal between two groups control no-floss and experimental flossing with Floss Loops during thirty 2 - days
Detailed Description:
At the screeningbaseline visit potential subjects will be given the IRB-approved informed consent form to read and ask questions After the subject signs and dates the consent the study representative will sign and date the consent to confirm that the consent process was completed before initiating any study procedures The subject will be given a copy of the signed consent The study dentist will collect and review information related to the subjects demographic medical and concomitant medications The subject will have a hard and soft tissue exam as well as a clinical examination of the gums and dental plaque present using the Lobene modified gingival index for gingivitis assessment the marginal bleeding on probing index and the Turesky modification of the Quigley and Hain plaque index
A total of 64 subjects who meet the study criteria will be enrolled and randomized into two groups 32 subjects will be assigned to the control group Brushing twice a day only and no flossing and 32 to the experimental group Brushing and Flossing with the stretchable loop floss twice daily Each subject will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice Subjects assigned to the control group will brush their teeth at least twice a day only and subjects in the experimental group will brush and floss with the provided stretchable loop floss at least twice a day To assess compliance each subject will be asked to fill out a diary every time they brushfloss On day 15 - 2 day of product use subjects will receive a phone call from the study coordinator or designee to assess brushingflossing compliance At day 30 - 2 study hygiene and gum chewing restrictions as well as eating restriction will apply and the efficacy assessments will be repeated subjects will be dismissed and the study will finish
All clinical examinations will be performed by examiners who will be blind to the subjects oral hygiene procedures
A total of 64 subjects who meet the study criteria will be enrolled and randomized into two groups 32 subjects will be assigned to the control group Brushing twice a day only and no flossing and 32 to the experimental group Brushing and Flossing with the stretchable loop floss twice daily Each subject will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice Subjects assigned to the control group will brush their teeth at least twice a day only and subjects in the experimental group will brush and floss with the provided stretchable loop floss at least twice a day To assess compliance each subject will be asked to fill out a diary every time they brushfloss On day 15 - 2 day of product use subjects will receive a phone call from the study coordinator or designee to assess brushingflossing compliance At day 30 - 2 study hygiene and gum chewing restrictions as well as eating restriction will apply and the efficacy assessments will be repeated subjects will be dismissed and the study will finish
All clinical examinations will be performed by examiners who will be blind to the subjects oral hygiene procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None