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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03109808
Other study ID # 16/065
Secondary ID
Status Recruiting
Phase N/A
First received April 6, 2017
Last updated April 11, 2017
Start date February 15, 2017
Est. completion date October 15, 2018

Study information

Verified date February 2017
Source Hospices Civils de Lyon
Contact Brigitte GROSGOGEAT
Phone +33 6 62 16 25 25
Email brigitte.grosgogeat@univ-lyon1.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 86
Est. completion date October 15, 2018
Est. primary completion date February 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Traditional Oral Hygiene Education
traditional oral hygiene education

Locations

Country Name City State
Belgium University Hospital Liege Liege
France Hospices Civils de Lyon - Service de Consultations et de Traitements Dentaires Lyon

Sponsors (2)

Lead Sponsor Collaborator
Hospices Civils de Lyon University Hospital of Liege

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Patient satisfaction Measured by a dedicated questionnaire 8 weeks
Secondary Patient motivation Measured by a dedicated questionnaire 8 weeks
See also
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