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

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ClinicalTrials.gov Identifier: NCT03109808
Recruitment Status : Unknown
Verified February 2017 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
University of Liege
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE April 12, 2017
Last Update Posted Date April 12, 2017
Actual Study Start Date  ICMJE February 15, 2017
Estimated Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • 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
  • Patient satisfaction [ Time Frame: 8 weeks ]
    Measured by a dedicated questionnaire
  • Patient motivation [ Time Frame: 8 weeks ]
    Measured by a dedicated questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of a Personalized Video in Oral Hygiene Motivation
Official Title  ICMJE Impact of a Personalized Video in Oral Hygiene Motivation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dental Hygiene
Intervention  ICMJE
  • 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.
  • Other: Traditional Oral Hygiene Education
    traditional oral hygiene education
Study Arms  ICMJE
  • Experimental: e-health strategy
    Assigned intervention: e-health strategy
    Intervention: Other: e-health strategy
  • Active Comparator: Traditional Oral Hygiene Education
    Assigned intervention: traditional oral hygiene education
    Intervention: Other: Traditional Oral Hygiene Education
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 11, 2017)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 15, 2018
Estimated Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03109808
Other Study ID Numbers  ICMJE 16/065
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE University of Liege
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP