NCT03109808

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

April 12, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

April 6, 2017

Last Update Submit

April 11, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Bleeding on Probing Index

    8 weeks

  • Patient satisfaction

    8 weeks

  • Patient motivation

    8 weeks

Study Arms (2)

e-health strategy

EXPERIMENTAL

Assigned intervention: e-health strategy

Other: e-health strategy

Traditional Oral Hygiene Education

ACTIVE COMPARATOR

Assigned intervention: traditional oral hygiene education

Other: Traditional Oral Hygiene Education

Interventions

* 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.

e-health strategy

traditional oral hygiene education

Traditional Oral Hygiene Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Liege

Liège, B-4000, Belgium

RECRUITING

Hospices Civils de Lyon - Service de Consultations et de Traitements Dentaires

Lyon, 69007, France

RECRUITING

Related Publications (1)

  • 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.

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: * 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 12, 2017

Study Start

February 15, 2017

Primary Completion

February 15, 2018

Study Completion

October 15, 2018

Last Updated

April 12, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations