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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Behavior
• Intervention / Treatment: Device: New Floss Holder - Gum Chucks; Device: New Floss Holder - Gum Chucks/SMS

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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; 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; 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	Device: 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	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

Collaborators and Investigators

• Sponsor: University of Lisbon

Publications and helpful links

General Publications

• Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): March 30, 2016
• Study Completion (Actual): March 30, 2016

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 15, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 15, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: SMS; behavior change; Gingivitis; HAPA; Dental floss
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: 07/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No