Behavior and Behavior MechanismsNCT03439969
A 8-month Study on the Use of Intra-oral Camera and Text Messages on Gingivitis Control
A study testing Mobile Text Messages and Intra Oral Camera in people with Behavior and Behavior Mechanisms and Gingivitis, run by University of Lisbon.
Trial summary
To investigate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy, and oral hygiene mobile text messages (SMS) between appointments on clinical, behavioral and psychological parameters of patients with gingivitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavior and Behavior Mechanisms, Gingivitis
- What is being tested?
- Mobile Text Messages and Intra Oral Camera
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 30 Nov 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: The Whole is Greater Than the Sum of Its Parts. "A 8-month Randomised Controlled Trial on the Use of Intra-oral Camera and Text Messages on Gingivitis Control"
To investigate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy, and oral hygiene mobile text messages (SMS) between appointments on clinical, behavioral and psychological parameters of patients with gingivitis.
Read the detailed description
Dental hygiene behaviours are of paramount importance for controlling gingival health. There is evidence on the use of IOC and of text messages in boosting motivation, sustainability and clinical efficacy of dental hygiene behaviors. Orchestrating these two technologies is expected to create a coaction effect which could improve behavior change interventions, but the effectiveness of such strategy needs to be inspected.
- Conditions
- Behavior and Behavior Mechanisms, Gingivitis
- Being tested
- Mobile Text Messages, Intra Oral Camera
- Keywords
- Gingivitis, SMS, Text messages, Behavior change, HAPA, Dental Hygiene
- Medical subject headings
- Behavior, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Text MessagesDevice
Dental inter-proximal control with floss holder and receiving 16 SMS during 4 months.
Intra Oral CameraDevice
SPT - Appointment with Intra-Oral Camera
- Examination and diagnosis (15 min) using Intra-oral camera.
- Motivation, discussion about desired outcomes and treatment needs (using Intra-oral camera) followed by instrumentation (scaling, polishing) (30 min).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Dental appointment, one hour and included activities that are normally part of a SPT (Suportive Periodontal Treatment) consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback considered crucial to the accomplishment of long term behavior change. Moreover, special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation) in order to focus patients´ attention on the varied facets of oral health care and increase their perception of the treatment needs. In this group, the device SOPROCARE® by Acteon and Text Messages were not used. |
| Intra Oral Camera | Experimental | Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills. Receives: Device: Intra Oral Camera |
| Mobile Text Messages | Experimental | Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback.. Participants in the SMS group further received a total of 16 messages (SMS). One per week. Receives: Device: Mobile Text Messages |
| Intra Oral Camera and Text Messages | Experimental | Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills.Participants also received SMS a total of 16 messages (SMS). One per week. Receives: Device: Mobile Text Messages; Device: Intra Oral Camera |
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 & 8 months
Gingival bleeding Index
Measured: Baseline, 4 months & 8 months
Secondary outcomes (4)
HAPA (Health Action Process Approach) behavioral variables questionnaire.
Measures adapted to oral health from previous studies with the HAPA model (Godinho et al. 2015) were used. All the HAPA variables were evaluated using a 7 point Likert-type scale, ranging from totally disagree (1) to totally agree (7), unless otherwise stated.
Measured: Baseline, 4 & 8 months.
SMS (Short Messages Service) text messages opinion questionnaire
Opinion about receiving SMS and how can it influence the appointment.
Measured: At 4 months.
Intra Oral Camera opinion questionnaire
Opinion about receiving Intra Oral camera and how can it influence the appointment.
Measured: At 4 and 8 months.
Self-report Dental Hygiene Behaviors questionnaire.
Level of toothbrushing and dental floss frequency.
Measured: Baseline, 4 and 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Jun 2014
- Primary completion28 Feb 2015
- Study completion30 Nov 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 Behavior and Behavior MechanismsStudies 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
- 233 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
- NCT03439969
- Sponsor's protocol ID
- Ethic Committee Doc. No. 6/14
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Godinho CA, Alvarez MJ, Lima ML, Schwarzer R. Health messages to promote fruit and vegetable consumption at different stages: A match-mismatch design. Psychol Health. 2015;30(12):1410-32. doi: 10.1080/08870446.2015.1054827. Epub 2015 Jul 24.
PubMed 26010304
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Whole is Greater Than the Sum of Its Parts. "A 8-month Randomised Controlled Trial on the Use of Intra-oral Camera and Text Messages on Gingivitis Control"
- ClinicalTrials.gov ID
- NCT03439969
- Acronym / sponsor ID
- Ethic Committee Doc. No. 6/14
- Conditions
- Behavior and Behavior Mechanisms, Gingivitis
- Keywords
- Gingivitis, SMS, Text messages, Behavior change, HAPA, Dental Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 28 Feb 2015 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 20 Feb 2018 (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.
To investigate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy, and oral hygiene mobile text messages (SMS) between appointments on clinical, behavioral and psychological parameters of patients with gingivitis.
Detailed description
Dental hygiene behaviours are of paramount importance for controlling gingival health. There is evidence on the use of IOC and of text messages in boosting motivation, sustainability and clinical efficacy of dental hygiene behaviors. Orchestrating these two technologies is expected to create a coaction effect which could improve behavior change interventions, but the effectiveness of such strategy needs to be inspected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Dental appointment, one hour and included activities that are normally part of a SPT (Suportive Periodontal Treatment) consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback considered crucial to the accomplishment of long term behavior change. Moreover, special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation) in order to focus patients´ attention on the varied facets of oral health care and increase their perception of the treatment needs. In this group, the device SOPROCARE® by Acteon and Text Messages were not used. |
| Intra Oral Camera | Experimental | Device: Intra Oral CameraDental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills. |
| Mobile Text Messages | Experimental | Device: Mobile Text MessagesDental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback.. Participants in the SMS group further received a total of 16 messages (SMS). One per week. |
| Intra Oral Camera and Text Messages | Experimental | Device: Mobile Text Messages, Device: Intra Oral CameraDental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills.Participants also received SMS a total of 16 messages (SMS). One per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gingivitis BOMP > 0.5 20 teeth (minimum 5 per quadrant) > 18 years old
Key exclusion criteria (1 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 |
|---|---|---|
| Mobile Text MessagesDental inter-proximal control with floss holder and receiving 16 SMS during 4 months. | Device | Intra Oral Camera and Text Messages, Mobile Text Messages |
| Intra Oral CameraSPT - Appointment with Intra-Oral Camera * Examination and diagnosis (15 min) using Intra-oral camera. * Motivation, discussion about desired outcomes and treatment needs (using Intra-oral camera) followed by instrumentation (scaling, polishing) (30 min). | Device | Intra Oral Camera, Intra Oral Camera and Text Messages |
Primary outcome
Change from BOMP (Bleeding on Marginal Probing) at 4 & 8 months
Time frame: Baseline, 4 months & 8 months
Gingival bleeding Index
4 secondary outcomes
HAPA (Health Action Process Approach) behavioral variables questionnaire.
Time frame: Baseline, 4 & 8 months.
SMS (Short Messages Service) text messages opinion questionnaire
Time frame: At 4 months.
Intra Oral Camera opinion questionnaire
Time frame: At 4 and 8 months.
Self-report Dental Hygiene Behaviors questionnaire.
Time frame: Baseline, 4 and 8 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 22 Feb 2018.
- Background: PubMed 26010304Godinho CA, Alvarez MJ, Lima ML, Schwarzer R. Health messages to promote fruit and vegetable consumption at different stages: A match-mismatch design. Psychol Health. 2015;30(12):1410-32. doi: 10.1080/08870446.2015.1054827. Epub 2015 Jul 24.
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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 Mobile Text Messages and Intra Oral Camera in people with Behavior and Behavior Mechanisms 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 1 inclusion and 1 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 22 Feb 2018. 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 & 8 months (time frame: Baseline, 4 months & 8 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 NCT03439969, 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 22 Feb 2018.