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

Not Applicable

Completed

• Conditions: Gingivitis; Behavior
• Interventions: Device: New Floss Holder - Gum Chucks; Device: New Floss Holder - Gum Chucks/SMS

• Registration Number: NCT03120559
• Lead Sponsor: University of Lisbon

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2016-03-30
• Study Completion: 2016-03-30
• Status Verified: 2017-04
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-15
• Last Update Submitted: 2017-04-15
• Study First Posted: 2017-04-19
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NFH - New Floss Holder	New Floss Holder - Gum Chucks	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
New Floss Holder and Short Messages	New Floss Holder - Gum Chucks/SMS	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

Primary Outcome Measures

Name	Time	Method
Change from BOMP (Bleeding on Marginal Probing) at 4 months	Baseline & 4 months	Gingival bleeding Index

Secondary Outcome Measures

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