Clinical trial NCT03109808: Impact of a Personalized Video in Oral Hygiene Motivation
Official title: Impact of a Personalized Video in Oral Hygiene Motivation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Hygiene
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: University of Liege
First posted: 2017-04-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: O'Leary Plaque Control Record
timeFrame: 8 weeks
Secondary outcomes:
measure: Bleeding on Probing Index
timeFrame: 8 weeks
measure: Patient satisfaction
timeFrame: 8 weeks
measure: Patient motivation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University Hospital Liege
city: Lyon
country: France
facility: Hospices Civils de Lyon - Service de Consultations et de Traitements Dentaires
Study officials:
References:
citation: 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.