Intra-oral Camera in Gingival Health

NCT ID: NCT02725983

Last Updated: 2016-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Gingival Hemorrhage Gingivitis Health Behavior Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

SPT consultation

Intervention Type BEHAVIORAL

SOPROCARE®

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

SPT consultation

Intervention Type BEHAVIORAL

Interventions

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SPT consultation

Intervention Type BEHAVIORAL

SOPROCARE®

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Psicologia

UNKNOWN

Sponsor Role collaborator

University of Lisbon

OTHER

Sponsor Role lead

Responsible Party

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Mario Rui Araújo

Master in Health psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria-João Maria-João, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Psicologia da Universidade de Lisboa

References

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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.

Reference Type BACKGROUND
PMID: 7806674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26010304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10589810 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25639708 (View on PubMed)

Other Identifiers

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06/2014

Identifier Type: -

Identifier Source: org_study_id

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