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

NCT ID: NCT03120559

Last Updated: 2017-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2016-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Behavior Gingivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
The researcher was blind to the patients

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type OTHER

New Floss Holder - Gum Chucks

Intervention Type DEVICE

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

Group Type OTHER

New Floss Holder - Gum Chucks/SMS

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

New Floss Holder - Gum Chucks

Dental inter-proximal control with GumChucks floss holder

Intervention Type DEVICE

New Floss Holder - Gum Chucks/SMS

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Lisbon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mario Rui Araújo

Master in Health Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 7806674 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07/2014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.