ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03109808
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
University Hospital of Liege
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Dental Hygiene Other: e-health strategy Other: Traditional Oral Hygiene Education Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Impact of a Personalized Video in Oral Hygiene Motivation
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : February 15, 2018
Estimated Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Bleeding on Probing Index [ Time Frame: 8 weeks ]
    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

  2. Patient satisfaction [ Time Frame: 8 weeks ]
    Measured by a dedicated questionnaire

  3. Patient motivation [ Time Frame: 8 weeks ]
    Measured by a dedicated questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109808


Contacts
Contact: Brigitte GROSGOGEAT +33 6 62 16 25 25 brigitte.grosgogeat@univ-lyon1.fr
Contact: François GUEYFFIER +33 4 78 78 57 55 francois.gueyffier@univ-lyon1.fr

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

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03109808     History of Changes
Other Study ID Numbers: 16/065
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No