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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

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.

Condition or disease Intervention/treatment Phase
Behavior and Behavior Mechanisms Gingivitis Device: Mobile Text Messages Device: Intra Oral Camera Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The researcher was blind to the patients
Primary Purpose: Prevention
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"
Actual Study Start Date : June 1, 2014
Actual Primary Completion Date : February 28, 2015
Actual Study Completion Date : November 30, 2016

Arm Intervention/treatment
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.
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).

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.
Device: Mobile Text Messages
Dental inter-proximal control with floss holder and receiving 16 SMS during 4 months.

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.
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).




Primary Outcome Measures :
  1. Change from BOMP (Bleeding on Marginal Probing) at 4 & 8 months [ Time Frame: Baseline, 4 months & 8 months ]
    Gingival bleeding Index


Secondary Outcome Measures :
  1. 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.

  2. SMS (Short Messages Service) text messages opinion questionnaire [ Time Frame: At 4 months. ]
    Opinion about receiving SMS and how can it influence the appointment.

  3. 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.

  4. Self-report Dental Hygiene Behaviors questionnaire. [ Time Frame: Baseline, 4 and 8 months. ]
    Level of toothbrushing and dental floss frequency.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications:
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Responsible Party: Mario Rui Araújo, Master in Health Psychology, University of Lisbon
ClinicalTrials.gov Identifier: NCT03439969    
Other Study ID Numbers: Ethic Committee Doc. No. 6/14
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mario Rui Araújo, University of Lisbon:
Gingivitis
SMS
Text messages
Behavior change
HAPA
Dental Hygiene
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases