Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT04218994
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2020-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Instructed Dental Flossing on Interdental Gingival Bleeding: A Randomized Controlled Clinical Trial
Sponsor:
Tufts University
Organization:
Study Overview
Official Title:
The Effect of Instructed Dental Flossing on Interdental Gingival Bleeding: A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study, half of the participants will be asked to floss as normal, while the other half will receive professional instructions on flossing from a dentist. The investigators want to see if the participants who have professional flossing instructions are able to remove plaque in between the teeth more effectively, and have less gum bleeding over time. The investigators also want to see if participants who receive professional flossing instructions get better at the technique over time, and if they can match the dentist's skill by the end of the study.
Detailed Description:
Primary Aim: To determine whether subjects instructed with a specific flossing technique have less gingival inflammation as evidenced by bleeding on probing (BoP) than subjects without flossing instructions.
Secondary Aim: To compare the effect of flossing by a dental professional with a patient's self-flossing following instruction in removing interdental plaque.
Secondary Aim: To compare the completeness of plaque removal by the subjects instructed during the initial visit (Group A \[test\]) with their completeness at the final (fourth) visit.
Secondary Aim: To compare the clinician's completeness of plaque removal at the fourth visit with the completeness of plaque removal by the subjects in both groups (Groups A \[test\] and B \[control\]). Each group will be analyzed separately. In Group A, a comparison of the plaque removal by the subjects and by the clinician will made with respect to the completeness at the first visit versus the final visit.
Secondary Aim: To compare the effect of flossing by a dental professional with a patient's self-flossing following instruction in removing interdental plaque.
Secondary Aim: To compare the completeness of plaque removal by the subjects instructed during the initial visit (Group A \[test\]) with their completeness at the final (fourth) visit.
Secondary Aim: To compare the clinician's completeness of plaque removal at the fourth visit with the completeness of plaque removal by the subjects in both groups (Groups A \[test\] and B \[control\]). Each group will be analyzed separately. In Group A, a comparison of the plaque removal by the subjects and by the clinician will made with respect to the completeness at the first visit versus the final visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: