Clinical trial NCT02725983: Intra-oral Camera in Gingival Health
Official title: Psychological, Behavioral and Clinical Effects of Intra Oral Camera: a Randomized Control Trial on Adults With Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Hemorrhage
Gingivitis
Health Behavior
Communication
Keywords: Gingivitis
Oral Hygiene
Intra oral camera
Self regulation
bleeding
Lead sponsor: University of Lisbon
Sponsor class: OTHER
Collaborators: name: Faculdade de Psicologia
First posted: 2016-04-01
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The gingival condition was assessed using the BOMP (Bleeding on Marginal Probing) index , as described by Van der Weijden et al. (1994).
timeFrame: Baseline to 4 months
Secondary outcomes:
measure: Dental Hygiene (Flossing and tooth-brushing habits)
timeFrame: Baseline to 4 months
measure: Measuring Health Behavior Change: Health Action Process Approach Model (HAPA, Schwarzer, 2008)
timeFrame: Baseline to 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Faculdade de Psicologia da Universidade de Lisboa
name: Maria-João Maria-João, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1600-051x.1994.tb00748.x.
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.
citation: 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.
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.