BehaviorNCT03120559
Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder
A study testing New Floss Holder - Gum Chucks and New Floss Holder - Gum Chucks/SMS in people with Behavior and Gingivitis, run by University of Lisbon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavior, Gingivitis
- What is being tested?
- New Floss Holder - Gum Chucks and New Floss Holder - Gum Chucks/SMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 30 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gingivitis BOMP > 0.5
- 20 teeth (minimum 5 per quadrant)
- > 18 years old
Who cannot join
- periodontitis (pockets >3),
- smoking,
- orthodontics,
- pregnancy
- removable partial dentures
About this study
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
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.
Read the 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.
- Conditions
- Behavior, Gingivitis
- Being tested
- New Floss Holder - Gum Chucks, New Floss Holder - Gum Chucks/SMS
- Keywords
- Gingivitis, SMS, Dental floss, behavior change, HAPA
- Medical subject headings
- Behavior, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Floss Holder - Gum ChucksDevice
Dental inter-proximal control with GumChucks floss holder
New Floss Holder - Gum Chucks/SMSDevice
Dental inter-proximal control with GumChucks floss holder and receiving 16 SMS during first 4 months.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: New Floss Holder - Gum Chucks/SMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from BOMP (Bleeding on Marginal Probing) at 4 months
Gingival bleeding Index
Measured: Baseline & 4 months
Secondary outcomes (3)
HAPA behavioral variables questionnaire.
Assessment of HAPA variables (same 5 points Likert scale for each of the variables)
Measured: Baseline & 4 months
SMS opinion questionnaire
Opinion about receiving SMS and how can it influence the appointment
Measured: 4 months
Self-report Dental Hygiene Behaviors questionnaire.
Level of tooth-brushing and dental floss frequency.
Measured: Baseline & 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Jun 2015
- Primary completion30 Mar 2016
- Study completion30 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Rui Araújo, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120559
- Sponsor's protocol ID
- 07/2014
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7806674
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03120559
- Acronym / sponsor ID
- 07/2014
- Conditions
- Behavior, Gingivitis
- Keywords
- Gingivitis, SMS, Dental floss, behavior change, HAPA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 30 Mar 2016 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: New Floss Holder - Gum ChucksThe 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 |
| New Floss Holder and Short Messages | Other | Device: New Floss Holder - Gum Chucks/SMSThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gingivitis BOMP > 0.5
- 20 teeth (minimum 5 per quadrant)
- > 18 years old
Key exclusion criteria (5 listed)
- periodontitis (pockets >3),
- smoking,
- orthodontics,
- pregnancy
- removable partial dentures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Floss Holder - Gum ChucksDental inter-proximal control with GumChucks floss holder | Device | NFH - New Floss Holder |
| New Floss Holder - Gum Chucks/SMSDental inter-proximal control with GumChucks floss holder and receiving 16 SMS during first 4 months. | Device | New Floss Holder and Short Messages |
Primary outcome
Change from BOMP (Bleeding on Marginal Probing) at 4 months
Time frame: Baseline & 4 months
Gingival bleeding Index
3 secondary outcomes
HAPA behavioral variables questionnaire.
Time frame: Baseline & 4 months
SMS opinion questionnaire
Time frame: 4 months
Self-report Dental Hygiene Behaviors questionnaire.
Time frame: Baseline & 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Background: PubMed 7806674Van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing New Floss Holder - Gum Chucks and New Floss Holder - Gum Chucks/SMS in people with Behavior and Gingivitis, run by University of Lisbon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from BOMP (Bleeding on Marginal Probing) at 4 months (time frame: Baseline & 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.