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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Behavior Gingivitis Device: New Floss Holder - Gum Chucks Device: New Floss Holder - Gum Chucks/SMS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The researcher was blind to the patients
Primary Purpose: Prevention
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
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : March 30, 2016
Actual Study Completion Date : March 30, 2016
Arms and Interventions
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Arm Intervention/treatment
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
 Device: New Floss Holder - Gum Chucks
Dental inter-proximal control with GumChucks floss holder
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from BOMP (Bleeding on Marginal Probing) at 4 months [ Time Frame: Baseline & 4 months ]
    Gingival bleeding Index


Secondary Outcome Measures :
  1. HAPA behavioral variables questionnaire. [ Time Frame: Baseline & 4 months ]
    Assessment of HAPA variables (same 5 points Likert scale for each of the variables)

  2. SMS opinion questionnaire [ Time Frame: 4 months ]
    Opinion about receiving SMS and how can it influence the appointment

  3. Self-report Dental Hygiene Behaviors questionnaire. [ Time Frame: Baseline & 4 months ]
    Level of tooth-brushing and dental floss frequency.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications:

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Responsible Party: Mario Rui Araújo, Master in Health Psychology, University of Lisbon
ClinicalTrials.gov Identifier: NCT03120559    
Other Study ID Numbers: 07/2014
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mario Rui Araújo, University of Lisbon:
Gingivitis
SMS
Dental floss
behavior change
HAPA
Additional relevant MeSH terms:
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Gingivitis
Infections
Gingival Diseases
 Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases