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Intra-oral Camera in Gingival Health

Primary Purpose

Gingival Hemorrhage, Gingivitis, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SPT consultation
SOPROCARE®
Sponsored by
University of Lisbon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingival Hemorrhage focused on measuring Gingivitis, Oral Hygiene, Intra oral camera, Self regulation, bleeding

Eligibility Criteria

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

Inclusion Criteria:

  • >18 years old.
  • + 20 teeth (minimum 5 per quadrant)
  • BOMP > 0.5

Exclusion Criteria:

  • periodontitis (pockets >4),
  • smoking patients
  • orthodontic patients
  • pregnant
  • 1 removable partial denture

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intra Oral Camera

    No Intra Oral camera

    Arm Description

    Dental appointment, one hour and included activities that are normally part of a SPT consultation (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015). 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 (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015) and 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 was not used.

    Outcomes

    Primary Outcome Measures

    The gingival condition was assessed using the BOMP (Bleeding on Marginal Probing) index , as described by Van der Weijden et al. (1994).
    In this index, bleeding is scored during 30 seconds of probing using a 3 point scale from 0 to 2 (0 - no bleeding, 1 - point bleeding, 2 - excess bleeding).

    Secondary Outcome Measures

    Dental Hygiene (Flossing and tooth-brushing habits)
    In order to assess dental hygiene, two questions were asked on brushing and flossing habits. Individual scores for brushing and flossing were calculated and a composite score was also computed for both (referred to as Dental Hygiene). A 5 point Likert-scale was used. Item example: In the last two weeks/four months how often have you flossed your teeth?
    Measuring Health Behavior Change: Health Action Process Approach Model (HAPA, Schwarzer, 2008)
    Measures adapted to oral health from previous studies with the HAPA model (Godinho et al. 2015) were used. All the psychological variables were evaluated using a 7 point Likert-type scale, ranging from totally disagree (1) to totally agree (7).

    Full Information

    First Posted
    March 18, 2016
    Last Updated
    March 31, 2016
    Sponsor
    University of Lisbon
    Collaborators
    Faculdade de Psicologia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02725983
    Brief Title
    Intra-oral Camera in Gingival Health
    Official Title
    Psychological, Behavioral and Clinical Effects of Intra Oral Camera: a Randomized Control Trial on Adults With Gingivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Lisbon
    Collaborators
    Faculdade de Psicologia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.
    Detailed Description
    A group of 78 adult patients with gingivitis receiving an SPT was randomized into two groups: IOC and control. Bleeding on Marginal Probing (BOMP), self-reported dental hygiene behaviors, and psychological determinants of behavior change (outcome expectancies, self-efficacy and planning) and IOC opinion were evaluated one week before or during the consultation and four months later.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Hemorrhage, Gingivitis, Health Behavior, Communication
    Keywords
    Gingivitis, Oral Hygiene, Intra oral camera, Self regulation, bleeding

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    78 (Actual)

    8. Arms, Groups, and Interventions

    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 (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015). 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
    No Intra Oral camera
    Arm Type
    Active Comparator
    Arm Description
    Dental appointment, one hour and included activities that are normally part of a SPT consultation (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015) and 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 was not used.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SPT consultation
    Intervention Type
    Device
    Intervention Name(s)
    SOPROCARE®
    Primary Outcome Measure Information:
    Title
    The gingival condition was assessed using the BOMP (Bleeding on Marginal Probing) index , as described by Van der Weijden et al. (1994).
    Description
    In this index, bleeding is scored during 30 seconds of probing using a 3 point scale from 0 to 2 (0 - no bleeding, 1 - point bleeding, 2 - excess bleeding).
    Time Frame
    Baseline to 4 months
    Secondary Outcome Measure Information:
    Title
    Dental Hygiene (Flossing and tooth-brushing habits)
    Description
    In order to assess dental hygiene, two questions were asked on brushing and flossing habits. Individual scores for brushing and flossing were calculated and a composite score was also computed for both (referred to as Dental Hygiene). A 5 point Likert-scale was used. Item example: In the last two weeks/four months how often have you flossed your teeth?
    Time Frame
    Baseline to 4 months
    Title
    Measuring Health Behavior Change: Health Action Process Approach Model (HAPA, Schwarzer, 2008)
    Description
    Measures adapted to oral health from previous studies with the HAPA model (Godinho et al. 2015) were used. All the psychological variables were evaluated using a 7 point Likert-type scale, ranging from totally disagree (1) to totally agree (7).
    Time Frame
    Baseline to 4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: >18 years old. + 20 teeth (minimum 5 per quadrant) BOMP > 0.5 Exclusion Criteria: periodontitis (pockets >4), smoking patients orthodontic patients pregnant 1 removable partial denture
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria-João Maria-João, PhD
    Organizational Affiliation
    Faculdade de Psicologia da Universidade de Lisboa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    7806674
    Citation
    Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.
    Results Reference
    background
    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
    background
    PubMed Identifier
    10589810
    Citation
    Bardet P, Suvan J, Lang NP. Clinical effects of root instrumentation using conventional steel or non-tooth substance removing plastic curettes during supportive periodontal therapy (SPT). J Clin Periodontol. 1999 Nov;26(11):742-7. doi: 10.1034/j.1600-051x.1999.t01-6-261101.x.
    Results Reference
    background
    PubMed Identifier
    25639708
    Citation
    Newton JT, Asimakopoulou K. Managing oral hygiene as a risk factor for periodontal disease: a systematic review of psychological approaches to behaviour change for improved plaque control in periodontal management. J Clin Periodontol. 2015 Apr;42 Suppl 16:S36-46. doi: 10.1111/jcpe.12356.
    Results Reference
    background

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    Intra-oral Camera in Gingival Health

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