NCT03120559

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

April 10, 2017

Last Update Submit

April 15, 2017

Conditions

BehaviorGingivitis

Keywords

GingivitisSMSDental flossbehavior changeHAPA

Outcome Measures

Primary Outcomes (1)

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

    Gingival bleeding Index

    Baseline & 4 months

Secondary Outcomes (3)

  • HAPA behavioral variables questionnaire.

    Baseline & 4 months

  • SMS opinion questionnaire

    4 months

  • Self-report Dental Hygiene Behaviors questionnaire.

    Baseline & 4 months

Study Arms (3)

Control

NO INTERVENTION

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

OTHER

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

New Floss Holder and Short Messages

OTHER

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

Interventions

New Floss Holder - Gum ChucksDEVICE

Dental inter-proximal control with GumChucks floss holder

NFH - New Floss Holder
New Floss Holder - Gum Chucks/SMSDEVICE

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

New Floss Holder and Short Messages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gingivitis BOMP \> 0.5
  • teeth (minimum 5 per quadrant)
  • \> 18 years old

You may not qualify if:

  • periodontitis (pockets \>3),
  • smoking,
  • orthodontics,
  • pregnancy
  • removable partial dentures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1111/j.1600-051x.1994.tb00748.x.

    PMID: 7806674BACKGROUND

MeSH Terms

Conditions

BehaviorGingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The researcher was blind to the patients
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master in Health Psychology

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 19, 2017

Study Start

June 1, 2015

Primary Completion

March 30, 2016

Study Completion

March 30, 2016

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share