Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder

Study Overview
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Brief Summary
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This study proposes to evaluate the effects of using a new floss holder (GumChuck) and the use of text messages during supportive periodontal therapy, on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.

Detailed Description
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Despite evidence on the benefits of controlling dental biofilm for preventing gingivitis, patients have difficulty complying. Floss holder devices and SMS may be useful in enhancing both the frequency and effectiveness of dental hygiene behaviors, by increasing patients' motivation and self-regulation efforts, but scarce scientific literature supporting their worth in controlling gingivitis and the underlying psychological processes is currently available.

Official Title
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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

Conditions
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Behavior, Gingivitis

Intervention / Treatment
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* Device: New Floss Holder - Gum Chucks
* Device: New Floss Holder - Gum Chucks/SMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The dental consultation was the same for all the groups. - Examination and diagnosis (15 min). - Motivation, discussion about desired outcomes and treatment needs followed by instrumentation (scaling, polishing) (30 min). - Therapeutic goals, therapeutic strategies, teaching skills (brushing and interproximal control with regular waxed floss at the Control group) and scheduling of the follow-up appointment (15 min). 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<br>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 | Device: New Floss Holder - Gum Chucks<br>* Dental inter-proximal control with GumChucks floss holder<br>|
| Other: New Floss Holder and Short Messages<br>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 | Device: New Floss Holder - Gum Chucks/SMS<br>* Dental inter-proximal control with GumChucks floss holder and receiving 16 SMS during first 4 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from BOMP (Bleeding on Marginal Probing) at 4 months | Gingival bleeding Index | Baseline & 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAPA behavioral variables questionnaire. | Assessment of HAPA variables (same 5 points Likert scale for each of the variables) | Baseline & 4 months | 
| SMS opinion questionnaire | Opinion about receiving SMS and how can it influence the appointment | 4 months | 
| Self-report Dental Hygiene Behaviors questionnaire. | Level of tooth-brushing and dental floss frequency. | Baseline & 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMS, Gingivitis, Dental floss, behavior change, HAPA