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Completed

NCT Number: NCT03120559

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

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.

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Key information

Conditions

Behavior Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New Floss Holder - Gum Chucks

Device

Dental inter-proximal control with GumChucks floss holder

New Floss Holder - Gum Chucks/SMS

Device

Dental inter-proximal control with GumChucks floss holder and receiving 16 SMS during first 4 months.

Primary outcomes

  1. Change from BOMP (Bleeding on Marginal Probing) at 4 months

    Time frame: Baseline & 4 months

    Gingival bleeding Index

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Lisbon

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 19, 2017
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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