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

Primary Purpose

Behavior, Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
New Floss Holder - Gum Chucks
New Floss Holder - Gum Chucks/SMS
Sponsored by
University of Lisbon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Behavior focused on measuring Gingivitis, SMS, Dental floss, behavior change, HAPA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Other

    Other

    Arm Label

    Control

    NFH - New Floss Holder

    New Floss Holder and Short Messages

    Arm Description

    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.

    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

    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

    Outcomes

    Primary Outcome Measures

    Change from BOMP (Bleeding on Marginal Probing) at 4 months
    Gingival bleeding Index

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 10, 2017
    Last Updated
    April 15, 2017
    Sponsor
    University of Lisbon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03120559
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    March 30, 2016 (Actual)
    Study Completion Date
    March 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Lisbon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Behavior, Gingivitis
    Keywords
    Gingivitis, SMS, Dental floss, behavior change, HAPA

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Masking Description
    The researcher was blind to the patients
    Allocation
    Randomized
    Enrollment
    144 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    NFH - New Floss Holder
    Arm Type
    Other
    Arm Description
    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
    Arm Title
    New Floss Holder and Short Messages
    Arm Type
    Other
    Arm Description
    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 Type
    Device
    Intervention Name(s)
    New Floss Holder - Gum Chucks
    Intervention Description
    Dental inter-proximal control with GumChucks floss holder
    Intervention Type
    Device
    Intervention Name(s)
    New Floss Holder - Gum Chucks/SMS
    Intervention Description
    Dental inter-proximal control with GumChucks floss holder and receiving 16 SMS during first 4 months.
    Primary Outcome Measure Information:
    Title
    Change from BOMP (Bleeding on Marginal Probing) at 4 months
    Description
    Gingival bleeding Index
    Time Frame
    Baseline & 4 months
    Secondary Outcome Measure Information:
    Title
    HAPA behavioral variables questionnaire.
    Description
    Assessment of HAPA variables (same 5 points Likert scale for each of the variables)
    Time Frame
    Baseline & 4 months
    Title
    SMS opinion questionnaire
    Description
    Opinion about receiving SMS and how can it influence the appointment
    Time Frame
    4 months
    Title
    Self-report Dental Hygiene Behaviors questionnaire.
    Description
    Level of tooth-brushing and dental floss frequency.
    Time Frame
    Baseline & 4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    7806674
    Citation
    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.
    Results Reference
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    Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder

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