Impact of a Personalized Video in Oral Hygiene Motivation (GOPERIO)

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.

Study Overview

• Status: Unknown
• Conditions: Dental Hygiene
• Intervention / Treatment: Other: e-health strategy; Other: Traditional Oral Hygiene Education

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 Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, B-4000
    • Recruiting
    • University Hospital Liege
    • Contact: France Lambert; Email: France.lambert@chu.ulg.ac.be
    • Contact: Marine Robert; Email: mrobert@chu.ulg.ac.be
• France
  • Lyon, France, 69007
    • Recruiting
    • Hospices Civils de Lyon - Service de Consultations et de Traitements Dentaires
    • Contact: Brigitte Grosgogeat; Phone Number: 33(0)4 27 85 40 00; Email: brigitte.grosgogeat@univ-lyon1.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: e-health strategy; Assigned intervention: e-health strategy	Other: 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.
Active Comparator: Traditional Oral Hygiene Education; Assigned intervention: traditional oral hygiene education	Other: Traditional Oral Hygiene Education; traditional oral hygiene education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks
Patient satisfaction	Measured by a dedicated questionnaire	8 weeks
Patient motivation	Measured by a dedicated questionnaire	8 weeks

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: University of Liege

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Anticipated): February 15, 2018
• Study Completion (Anticipated): October 15, 2018

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 16/065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No