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Completed

NCT Number: NCT02725983

Intra-oral Camera in Gingival Health

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.

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Key information

Conditions

Gingival Hemorrhage Behavior Communication Gingival Diseases Gingivitis Health Behavior Hemorrhage Infections Mouth Diseases Oral Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Self-Control Social Behavior Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPT consultation

Behavioral

SOPROCARE®

Device

Primary outcomes

  1. The gingival condition was assessed using the BOMP (Bleeding on Marginal Probing) index , as described by Van der Weijden et al. (1994).

    Time frame: Baseline to 4 months

    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 outcomes

  1. Dental Hygiene (Flossing and tooth-brushing habits)

    Time frame: Baseline to 4 months

    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?

  2. Measuring Health Behavior Change: Health Action Process Approach Model (HAPA, Schwarzer, 2008)

    Time frame: Baseline to 4 months

    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).

Sponsors and collaborators

Lead sponsor

University of Lisbon

Other

Collaborators

  • Faculdade de Psicologia

Registry information

Official study title

Psychological, Behavioral and Clinical Effects of Intra Oral Camera: a Randomized Control Trial on Adults With Gingivitis

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 1, 2016
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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