- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03120559
Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder
Can we Still Save Dental Floss? Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder in a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Gingivitis BOMP > 0.5
- 20 teeth (minimum 5 per quadrant)
- > 18 years old
Exclusion Criteria:
- periodontitis (pockets >3),
- smoking,
- orthodontics,
- pregnancy
- removable partial dentures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
The dental consultation was the same for all the groups.
They were properly organized in accordance with the features of each patient, such as their gingival condition, gingivitis perception, habits and expectancies concerning the treatment. The consultation time was 60 minutes and also included specific behavior change techniques, such as reinforcement, goal-setting, and feedback. |
|
Other: NFH - New Floss Holder
The dental consultation was the same for all the groups.
They were properly organized in accordance with the features of each patient, such as their gingival condition, gingivitis perception, habits and expectancies concerning the treatment.
The consultation time was 60 minutes and also included specific behavior change techniques, such as reinforcement, goal-setting, and feedback.
New Floss Holder - Gum Chucks
|
Dental inter-proximal control with GumChucks floss holder
|
Other: New Floss Holder and Short Messages
The dental consultation was the same for all the groups. They were properly organized in accordance with the features of each patient, such as their gingival condition, gingivitis perception, habits and expectancies concerning the treatment. The Intervention time was 60 minutes and also included behavior change techniques, such as reinforcement, goal-setting, and feedback. Participants in the NFH/SMS group further received a total of 16 messages (SMS). New Floss Holder - Gum Chucks/SMS |
Dental inter-proximal control with GumChucks floss holder and receiving 16 SMS during first 4 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from BOMP (Bleeding on Marginal Probing) at 4 months
Time Frame: Baseline & 4 months
|
Gingival bleeding Index
|
Baseline & 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HAPA behavioral variables questionnaire.
Time Frame: Baseline & 4 months
|
Assessment of HAPA variables (same 5 points Likert scale for each of the variables)
|
Baseline & 4 months
|
SMS opinion questionnaire
Time Frame: 4 months
|
Opinion about receiving SMS and how can it influence the appointment
|
4 months
|
Self-report Dental Hygiene Behaviors questionnaire.
Time Frame: Baseline & 4 months
|
Level of tooth-brushing and dental floss frequency.
|
Baseline & 4 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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