Intra-oral Camera in Gingival Health

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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Communication; Health Behavior; Gingival Hemorrhage
• Intervention / Treatment: Behavioral: SPT consultation; Device: SOPROCARE®

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra Oral Camera; 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.	Behavioral: SPT consultation; Device: SOPROCARE®
Active Comparator: No Intra Oral camera; 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.	Behavioral: SPT consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	Baseline to 4 months
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).	Baseline to 4 months

Collaborators and Investigators

• Sponsor: University of Lisbon
• Collaborators: Faculdade de Psicologia
• Investigators: Principal Investigator: Maria-João Maria-João, PhD, Faculdade de Psicologia da Universidade de Lisboa

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 18, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Estimate): April 1, 2016
• Last Update Submitted That Met QC Criteria: March 31, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: bleeding; Oral Hygiene; Gingivitis; Self regulation; Intra oral camera
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Oral Hemorrhage; Hemorrhage; Gingivitis; Gingival Hemorrhage
• Other Study ID Numbers: 06/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO