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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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ClinicalTrials.gov Identifier: NCT03439969
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mario Rui Araújo, University of Lisbon

Tracking Information
First Submitted Date  ICMJE February 13, 2018
First Posted Date  ICMJE February 20, 2018
Last Update Posted Date February 22, 2018
Actual Study Start Date  ICMJE June 1, 2014
Actual Primary Completion Date February 28, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
Change from BOMP (Bleeding on Marginal Probing) at 4 & 8 months [ Time Frame: Baseline, 4 months & 8 months ]
Gingival bleeding Index
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
  • HAPA (Health Action Process Approach) behavioral variables questionnaire. [ Time Frame: Baseline, 4 & 8 months. ]
    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 [ Time Frame: At 4 months. ]
    Opinion about receiving SMS and how can it influence the appointment.
  • Intra Oral Camera opinion questionnaire [ Time Frame: At 4 and 8 months. ]
    Opinion about receiving Intra Oral camera and how can it influence the appointment.
  • Self-report Dental Hygiene Behaviors questionnaire. [ Time Frame: Baseline, 4 and 8 months. ]
    Level of toothbrushing and dental floss frequency.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • HAPA (Health Action Process Approach) behavioral variables questionnaire. [ Time Frame: Baseline, 4 & 8 months. ]
    Assessment of HAPA variables (same 5 points Likert scale for each of the variables)
  • SMS (Short Messages Service) text messages opinion questionnaire [ Time Frame: At 4 months. ]
    Opinion about receiving SMS and how can it influence the appointment.
  • Intra Oral Camera opinion questionnaire [ Time Frame: At 4 and 8 months. ]
    Opinion about receiving Intra Oral camera and how can it influence the appointment.
  • Self-report Dental Hygiene Behaviors questionnaire. [ Time Frame: Baseline, 4 and 8 months. ]
    Level of toothbrushing and dental floss frequency.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 8-month Study on the Use of Intra-oral Camera and Text Messages on Gingivitis Control
Official Title  ICMJE 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"
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:
The researcher was blind to the patients
Primary Purpose: Prevention
Condition  ICMJE
  • Behavior and Behavior Mechanisms
  • Gingivitis
Intervention  ICMJE
  • Device: Mobile Text Messages
    Dental inter-proximal control with floss holder and receiving 16 SMS during 4 months.
  • Device: Intra Oral Camera

    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).
Study Arms  ICMJE
  • No Intervention: Control
    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.
  • Experimental: Intra Oral Camera
    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.
    Intervention: Device: Intra Oral Camera
  • Experimental: Mobile Text Messages
    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.
    Intervention: Device: Mobile Text Messages
  • Experimental: Intra Oral Camera and Text Messages
    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.
    Interventions:
    • Device: Mobile Text Messages
    • Device: Intra Oral Camera
Publications * 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.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2018)
233
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2016
Actual Primary Completion Date February 28, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03439969
Other Study ID Numbers  ICMJE Ethic Committee Doc. No. 6/14
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 Not Provided
Responsible Party Mario Rui Araújo, University of Lisbon
Study Sponsor  ICMJE University of Lisbon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Lisbon
Verification Date February 2018

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