Intra-oral Camera in Gingival Health

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725983
• Other study ID #: 06/2014
• Status: Completed
• Phase: N/A
• First received: March 18, 2016
• Last updated: March 31, 2016
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communication
• Gingival Hemorrhage
• Gingivitis
• Health Behavior

Intervention

Behavioral:
• SPT consultation

Device:
• SOPROCARE®

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Lisbon	Faculdade de Psicologia

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No