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

Gingivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120559
• Other study ID #: 07/2014
• Status: Completed
• Phase: N/A
• First received: April 10, 2017
• Last updated: April 15, 2017
• Start date: June 1, 2015
• Est. completion date: March 30, 2016

Study information

• Verified date: April 2017
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 30, 2016
• Est. primary completion date: March 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior
• Gingivitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Lisbon

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from BOMP (Bleeding on Marginal Probing) at 4 months	Gingival bleeding Index	Baseline & 4 months
Secondary	HAPA behavioral variables questionnaire.	Assessment of HAPA variables (same 5 points Likert scale for each of the variables)	Baseline & 4 months
Secondary	SMS opinion questionnaire	Opinion about receiving SMS and how can it influence the appointment	4 months
Secondary	Self-report Dental Hygiene Behaviors questionnaire.	Level of tooth-brushing and dental floss frequency.	Baseline & 4 months