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

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

Tracking Information
First Submitted Date  ICMJE April 10, 2017
First Posted Date  ICMJE April 19, 2017
Last Update Posted Date April 19, 2017
Actual Study Start Date  ICMJE June 1, 2015
Actual Primary Completion Date March 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:
The researcher was blind to the patients
Primary Purpose: Prevention
Condition  ICMJE
  • Behavior
  • Gingivitis
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2017)
144
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2016
Actual Primary Completion Date March 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03120559
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Mario Rui Araújo, University of Lisbon
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Lisbon
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Lisbon
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP