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A 8-month Study on the Use of Intra-oral Camera and Text Messages on Gingivitis Control

Primary Purpose

Behavior and Behavior Mechanisms, Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile Text Messages
Intra Oral Camera
Sponsored by
University of Lisbon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Behavior and Behavior Mechanisms focused on measuring Gingivitis, SMS, Text messages, Behavior change, HAPA, Dental Hygiene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Gingivitis BOMP > 0.5 20 teeth (minimum 5 per quadrant) > 18 years old

Exclusion Criteria:

periodontitis (pockets >3), smoking, orthodontics, pregnancy removable partial dentures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    Intra Oral Camera

    Mobile Text Messages

    Intra Oral Camera and Text Messages

    Arm Description

    Dental appointment, one hour and included activities that are normally part of a SPT (Suportive Periodontal Treatment) consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback considered crucial to the accomplishment of long term behavior change. Moreover, special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation) in order to focus patients´ attention on the varied facets of oral health care and increase their perception of the treatment needs. In this group, the device SOPROCARE® by Acteon and Text Messages were not used.

    Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills.

    Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback.. Participants in the SMS group further received a total of 16 messages (SMS). One per week.

    Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills.Participants also received SMS a total of 16 messages (SMS). One per week.

    Outcomes

    Primary Outcome Measures

    Change from BOMP (Bleeding on Marginal Probing) at 4 & 8 months
    Gingival bleeding Index

    Secondary Outcome Measures

    HAPA (Health Action Process Approach) behavioral variables questionnaire.
    Measures adapted to oral health from previous studies with the HAPA model (Godinho et al. 2015) were used. All the HAPA variables were evaluated using a 7 point Likert-type scale, ranging from totally disagree (1) to totally agree (7), unless otherwise stated.
    SMS (Short Messages Service) text messages opinion questionnaire
    Opinion about receiving SMS and how can it influence the appointment.
    Intra Oral Camera opinion questionnaire
    Opinion about receiving Intra Oral camera and how can it influence the appointment.
    Self-report Dental Hygiene Behaviors questionnaire.
    Level of toothbrushing and dental floss frequency.

    Full Information

    First Posted
    February 13, 2018
    Last Updated
    February 19, 2018
    Sponsor
    University of Lisbon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03439969
    Brief Title
    A 8-month Study on the Use of Intra-oral Camera and Text Messages on Gingivitis Control
    Official Title
    The Whole is Greater Than the Sum of Its Parts. "A 8-month Randomised Controlled Trial on the Use of Intra-oral Camera and Text Messages on Gingivitis Control"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2014 (Actual)
    Primary Completion Date
    February 28, 2015 (Actual)
    Study Completion Date
    November 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Lisbon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To investigate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy, and oral hygiene mobile text messages (SMS) between appointments on clinical, behavioral and psychological parameters of patients with gingivitis.
    Detailed Description
    Dental hygiene behaviours are of paramount importance for controlling gingival health. There is evidence on the use of IOC and of text messages in boosting motivation, sustainability and clinical efficacy of dental hygiene behaviors. Orchestrating these two technologies is expected to create a coaction effect which could improve behavior change interventions, but the effectiveness of such strategy needs to be inspected.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Behavior and Behavior Mechanisms, Gingivitis
    Keywords
    Gingivitis, SMS, Text messages, Behavior change, HAPA, Dental Hygiene

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Masking Description
    The researcher was blind to the patients
    Allocation
    Randomized
    Enrollment
    233 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Dental appointment, one hour and included activities that are normally part of a SPT (Suportive Periodontal Treatment) consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback considered crucial to the accomplishment of long term behavior change. Moreover, special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation) in order to focus patients´ attention on the varied facets of oral health care and increase their perception of the treatment needs. In this group, the device SOPROCARE® by Acteon and Text Messages were not used.
    Arm Title
    Intra Oral Camera
    Arm Type
    Experimental
    Arm Description
    Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills.
    Arm Title
    Mobile Text Messages
    Arm Type
    Experimental
    Arm Description
    Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback.. Participants in the SMS group further received a total of 16 messages (SMS). One per week.
    Arm Title
    Intra Oral Camera and Text Messages
    Arm Type
    Experimental
    Arm Description
    Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills.Participants also received SMS a total of 16 messages (SMS). One per week.
    Intervention Type
    Device
    Intervention Name(s)
    Mobile Text Messages
    Intervention Description
    Dental inter-proximal control with floss holder and receiving 16 SMS during 4 months.
    Intervention Type
    Device
    Intervention Name(s)
    Intra Oral Camera
    Intervention Description
    SPT - Appointment with Intra-Oral Camera Examination and diagnosis (15 min) using Intra-oral camera. Motivation, discussion about desired outcomes and treatment needs (using Intra-oral camera) followed by instrumentation (scaling, polishing) (30 min).
    Primary Outcome Measure Information:
    Title
    Change from BOMP (Bleeding on Marginal Probing) at 4 & 8 months
    Description
    Gingival bleeding Index
    Time Frame
    Baseline, 4 months & 8 months
    Secondary Outcome Measure Information:
    Title
    HAPA (Health Action Process Approach) behavioral variables questionnaire.
    Description
    Measures adapted to oral health from previous studies with the HAPA model (Godinho et al. 2015) were used. All the HAPA variables were evaluated using a 7 point Likert-type scale, ranging from totally disagree (1) to totally agree (7), unless otherwise stated.
    Time Frame
    Baseline, 4 & 8 months.
    Title
    SMS (Short Messages Service) text messages opinion questionnaire
    Description
    Opinion about receiving SMS and how can it influence the appointment.
    Time Frame
    At 4 months.
    Title
    Intra Oral Camera opinion questionnaire
    Description
    Opinion about receiving Intra Oral camera and how can it influence the appointment.
    Time Frame
    At 4 and 8 months.
    Title
    Self-report Dental Hygiene Behaviors questionnaire.
    Description
    Level of toothbrushing and dental floss frequency.
    Time Frame
    Baseline, 4 and 8 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gingivitis BOMP > 0.5 20 teeth (minimum 5 per quadrant) > 18 years old Exclusion Criteria: periodontitis (pockets >3), smoking, orthodontics, pregnancy removable partial dentures

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26010304
    Citation
    Godinho CA, Alvarez MJ, Lima ML, Schwarzer R. Health messages to promote fruit and vegetable consumption at different stages: A match-mismatch design. Psychol Health. 2015;30(12):1410-32. doi: 10.1080/08870446.2015.1054827. Epub 2015 Jul 24.
    Results Reference
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    A 8-month Study on the Use of Intra-oral Camera and Text Messages on Gingivitis Control

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