Dental HygieneGOPERIONCT03109808
Impact of a Personalized Video in Oral Hygiene Motivation
A study testing e-health strategy and Traditional Oral Hygiene Education in people with Dental Hygiene, run by Hospices Civils de Lyon at 2 sites in 2 countries.
Trial summary
Impact of a personalized video in oral hygiene motivation: The study hypothesis is that the use of a personalized oral hygiene video, made available to the patient via a cloud-based system, in conjunction with a text-based two-way recall system will increase patient compliance, hence leading to improvement or oral… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Hygiene
- What is being tested?
- e-health strategy and Traditional Oral Hygiene Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Feb 2017to 15 Oct 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old and older, having a good understanding of French language (read, write, speak, listen)
- With at least 20 teeth, including 4 first molars and 4 first or second premolars (4 interdental sites between premolars and molars)
- Patient attending an appointment in a centre participating to the trial
- Patient able to support treatment
- Patient affiliated to a health insurance scheme
- Patient giving his informed consent and accepting the modalities of the study
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- Patient agreeing to attend up to 4 appointments dedicated to the study, during 8 weeks after the initial appointment (motivational interview)
- Patient in possession of an internet-enabled smartphone or tablet
- Patient has a personal e-mail address
- Patient agreeing to be registered within the system of text-based recalls for the duration of the study
Who cannot join
- Patient having previously benefited from a periodontal therapy (less than 1 year ago) or currently enrolled in a periodontal therapy program
- Patient having previously benefited from an oral hygiene motivation session less than 1 year ago
- Patient has had a calculus removal procedure less than 1 month ago
- Patient bears orthodontic appliances (any kind, for 1 or both arches)
- Patient bears removable dental prosthesis (any kind, for 1 or both arches)
- Patient allergic to benzoic acid preservatives (or thought to be)
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- Patient has a high risk of infective endocarditis
- Patient benefiting from antiaggregant or anticoagulation therapy
- Patient is haemophilic
- Patient is unable to answer questions
- Patient is unable (from a cognitive or physical standpoint) to perform toothbrushing twice a day
- Patient is unable (from a cognitive or physical standpoint) to use interdental brushes and/or dental floss (at least once a day)
- Patient uses on a regular basis (more than once a week) interdental brushes and/or dental floss in addition to toothbrushing
- Patient under tutelage or guardianship
- Patient deaf or blind
- Non cooperative patient
- Patient will be changing geographical location (ie. moving away) during the duration of the study, hence compromising follow-up visits
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Liege
Liège, B-4000
France Lambert, France.lambert@chu.ulg.ac.be
Marine Robert, mrobert@chu.ulg.ac.be
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon - Service de Consultations et de Traitements Dentaires
Lyon, 69007
Brigitte Grosgogeat, 33(0)4 27 85 40 00, brigitte.grosgogeat@univ-lyon1.fr
About this study
Impact of a personalized video in oral hygiene motivation: The study hypothesis is that the use of a personalized oral hygiene video, made available to the patient via a cloud-based system, in conjunction with a text-based two-way recall system will increase patient compliance, hence leading to improvement or oral hygiene.
Read the detailed description
The strategy studied is composite:
- First, a personalized video of the patient's oral hygiene routine (toothbrushing and interdental hygiene) is recorded and made available to him-her via a cloud-based system. The patient is instructed to view it with his-her smartphone and/or tablet when brushing his-her teeth.
- Second, the patient is registered in a text-based recall system. This recall system will remind him-her the oral hygiene regimen suited to his-her personal situation and contains a link to his cloud-hosted video. 12 text messages for each patient will be sent over the course of the study (8 weeks). This is a two-way system as patients will be inquired about their compliance to oral hygiene. If the patient declare compliance, he-she will be congratulated (positive reinforcement). If the patient declares non-compliance, he-she will be informed he-she will be offered additional counselling at the next appointment.
- Conditions
- Dental Hygiene
- Being tested
- e-health strategy, Traditional Oral Hygiene Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-health strategyOther
- First, a personalized video of the patient's oral hygiene routine (toothbrushing and interdental hygiene) is recorded and made available to him-her via a cloud-based system. The patient is instructed to view it with his-her smartphone and/or tablet when brushing his-her teeth.
- Second, the patient is registered in a text-based recall system. This recall system will remind him-her the oral hygiene regimen suited to his-her personal situation and contains a link to his cloud-hosted video. 12 text messages for each patient will be sent over the course of the study (8 weeks). This is a two-way system as patients will be inquired about their compliance to oral hygiene. If the patient declare compliance, he-she will be congratulated (positive reinforcement). If the patient declares non-compliance, he-she will be informed he-she will be offered additional counselling at the next appointment.
Traditional Oral Hygiene EducationOther
traditional oral hygiene education
| Study group | Role | What they receive |
|---|---|---|
| e-health strategy | Experimental | Assigned intervention: e-health strategy Receives: Other: e-health strategy |
| Traditional Oral Hygiene Education | Active comparator | Assigned intervention: traditional oral hygiene education Receives: Other: Traditional Oral Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
O'Leary Plaque Control Record
Measures the presence (1) or absence (0) of dental plaque on 6 sites per tooth for all teeth in mouth
Measured: 8 weeks
Secondary outcomes (3)
Bleeding on Probing Index
Measures the presence (1) or absence (0) of bleeding at the gingival margin up to 30 seconds after the insertion of the periodontal probe in the sulcus
Measured: 8 weeks
Patient satisfaction
Measured by a dedicated questionnaire
Measured: 8 weeks
Patient motivation
Measured by a dedicated questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start15 Feb 2017
- Primary completion15 Feb 2018 (estimated)
- Study completion15 Oct 2018 (estimated)
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 Dental HygieneStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Model description
- * Allocation : Randomized (with stratification on center and gender) * Endpoint Classification : Safety/Efficacy Study * Intervention Model : Parallel Assignment * Masking : Double blind (Operator, Outcomes Assessor) * Primary Purpose : Prevention
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109808
- Sponsor's protocol ID
- 16/065
- Acronym
- GOPERIO
- Status last verified
- Feb 2017
- First submitted
- 6 Apr 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garyga V, Pochelu F, Thivichon-Prince B, Aouini W, Santamaria J, Lambert F, Maucort-Boulch D, Gueyffier F, Gritsch K, Grosgogeat B. GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial. Trials. 2019 Dec 10;20(1):699. doi: 10.1186/s13063-019-3738-0.
PubMed 31823812
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Personalized Video in Oral Hygiene Motivation
- ClinicalTrials.gov ID
- NCT03109808
- Acronym / sponsor ID
- GOPERIO / 16/065
- Conditions
- Dental Hygiene
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- University of Liege
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Feb 2018 (estimated)
- Study completion
- 15 Oct 2018 (estimated)
- First posted
- 12 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.
Impact of a personalized video in oral hygiene motivation: The study hypothesis is that the use of a personalized oral hygiene video, made available to the patient via a cloud-based system, in conjunction with a text-based two-way recall system will increase patient compliance, hence leading to improvement or oral hygiene.
Detailed description
The strategy studied is composite:
- First, a personalized video of the patient's oral hygiene routine (toothbrushing and interdental hygiene) is recorded and made available to him-her via a cloud-based system. The patient is instructed to view it with his-her smartphone and/or tablet when brushing his-her teeth.
- Second, the patient is registered in a text-based recall system. This recall system will remind him-her the oral hygiene regimen suited to his-her personal situation and contains a link to his cloud-hosted video. 12 text messages for each patient will be sent over the course of the study (8 weeks). This is a two-way system as patients will be inquired about their compliance to oral hygiene. If the patient declare compliance, he-she will be congratulated (positive reinforcement). If the patient declares non-compliance, he-she will be informed he-she will be offered additional counselling at the next appointment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- * Allocation : Randomized (with stratification on center and gender) * Endpoint Classification : Safety/Efficacy Study * Intervention Model : Parallel Assignment * Masking : Double blind (Operator, Outcomes Assessor) * Primary Purpose : Prevention
| Arm | Type | Receives |
|---|---|---|
| e-health strategy | Experimental | Other: e-health strategyAssigned intervention: e-health strategy |
| Traditional Oral Hygiene Education | Active comparator | Other: Traditional Oral Hygiene EducationAssigned intervention: traditional oral hygiene education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years old and older, having a good understanding of French language (read, write, speak, listen)
- With at least 20 teeth, including 4 first molars and 4 first or second premolars (4 interdental sites between premolars and molars)
- Patient attending an appointment in a centre participating to the trial
- Patient able to support treatment
- Patient affiliated to a health insurance scheme
Key exclusion criteria (17 listed)
- Patient having previously benefited from a periodontal therapy (less than 1 year ago) or currently enrolled in a periodontal therapy program
- Patient having previously benefited from an oral hygiene motivation session less than 1 year ago
- Patient has had a calculus removal procedure less than 1 month ago
- Patient bears orthodontic appliances (any kind, for 1 or both arches)
- Patient bears removable dental prosthesis (any kind, for 1 or both arches)
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 |
|---|---|---|
| e-health strategy* First, a personalized video of the patient's oral hygiene routine (toothbrushing and interdental hygiene) is recorded and made available to him-her via a cloud-based system. The patient is instructed to view it with his-her smartphone and/or tablet when brushing his-her teeth. * Second, the patient is registered in a text-based recall system. This recall system will remind him-her the oral hygiene regimen suited to his-her personal situation and contains a link to his cloud-hosted video. 12 text messages for each patient will be sent over the course of the study (8 weeks). This is a two-way system as patients will be inquired about their compliance to oral hygiene. If the patient declare compliance, he-she will be congratulated (positive reinforcement). If the patient declares non-compliance, he-she will be informed he-she will be offered additional counselling at the next appointment. | Other | e-health strategy |
| Traditional Oral Hygiene Educationtraditional oral hygiene education | Other | Traditional Oral Hygiene Education |
Primary outcome
O'Leary Plaque Control Record
Time frame: 8 weeks
Measures the presence (1) or absence (0) of dental plaque on 6 sites per tooth for all teeth in mouth
3 secondary outcomes
Bleeding on Probing Index
Time frame: 8 weeks
Patient satisfaction
Time frame: 8 weeks
Patient motivation
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Derived from this study: PubMed 31823812Garyga V, Pochelu F, Thivichon-Prince B, Aouini W, Santamaria J, Lambert F, Maucort-Boulch D, Gueyffier F, Gritsch K, Grosgogeat B. GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial. Trials. 2019 Dec 10;20(1):699. doi: 10.1186/s13063-019-3738-0.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-health strategy and Traditional Oral Hygiene Education in people with Dental Hygiene, run by Hospices Civils de Lyon at 2 sites in 2 countries.
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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brigitte GROSGOGEAT (+33 6 62 16 25 25, brigitte.grosgogeat@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
O'Leary Plaque Control Record (time frame: 8 weeks). 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 NCT03109808, 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 12 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.