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

• ClinicalTrials.gov Identifier: NCT03120559
• Recruitment Status: Completed
• First Posted: April 19, 2017
• Last Update Posted: April 19, 2017
• Sponsor: University of Lisbon
• Information provided by (Responsible Party): Mario Rui Araújo, University of Lisbon

Tracking Information

• First Submitted Date: April 10, 2017
• First Posted Date: April 19, 2017
• Last Update Posted Date: April 19, 2017
• Actual Study Start Date: June 1, 2015
• Actual Primary Completion Date: March 30, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 15, 2017)

Change from BOMP (Bleeding on Marginal Probing) at 4 months [ Time Frame: Baseline & 4 months ]

Gingival bleeding Index

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 15, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder
• Official Title: 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
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:

The researcher was blind to the patients

Primary Purpose: Prevention

Condition

• Behavior
• Gingivitis

Intervention

• Device: New Floss Holder - Gum Chucks
  Dental inter-proximal control with GumChucks floss holder
• Device: New Floss Holder - Gum Chucks/SMS
  Dental inter-proximal control with GumChucks floss holder and receiving 16 SMS during first 4 months.

Study Arms

• No Intervention: Control

  The dental consultation was the same for all the groups.

  1. - Examination and diagnosis (15 min).
  2. - Motivation, discussion about desired outcomes and treatment needs followed by instrumentation (scaling, polishing) (30 min).
  3. - 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.

• 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
  Intervention: Device: New Floss Holder - Gum Chucks
• 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

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 15, 2017): 144
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 30, 2016
• Actual Primary Completion Date: March 30, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03120559
• Other Study ID Numbers: 07/2014
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Mario Rui Araújo, University of Lisbon
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Lisbon
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Lisbon
• Verification Date: April 2017