Intra-oral Camera in Gingival Health

NCT02725983 | Completed

• 1 other identifier: 06/2014
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Hemorrhage; Gingivitis; Health Behavior; Communication

Keywords

Gingivitis; Oral Hygiene; Intra oral camera; Self regulation; bleeding

Outcome Measures

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).

  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 Outcomes (2)

• Dental Hygiene (Flossing and tooth-brushing habits)

  Baseline to 4 months

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

  Baseline to 4 months

Study Arms (2)

Intra Oral Camera

EXPERIMENTAL

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®

No Intra Oral camera

ACTIVE COMPARATOR

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

Interventions

SPT consultation BEHAVIORAL

Intra Oral Camera; No Intra Oral camera

SOPROCARE® DEVICE

Intra Oral Camera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old.
• \+ 20 teeth (minimum 5 per quadrant)
• BOMP \> 0.5

You may not qualify if:

• periodontitis (pockets \>4),
• smoking patients
• orthodontic patients
• pregnant
• removable partial denture

Sponsors & Collaborators

• University of Lisbon: lead
• Faculdade de Psicologia: collaborator

Related Publications (4)

• 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.

  PMID: 7806674 BACKGROUND

• 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.

  PMID: 26010304 BACKGROUND

• 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.

  PMID: 10589810 BACKGROUND

• 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.

  PMID: 25639708 BACKGROUND

MeSH Terms

Conditions

Gingival Hemorrhage; Gingivitis; Health Behavior; Communication; Self-Control; Hemorrhage

Condition Hierarchy (Ancestors)

Oral Hemorrhage; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Behavior; Social Behavior

Study Officials

• Maria-João Maria-João, PhD

  Faculdade de Psicologia da Universidade de Lisboa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Health psychology

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 1, 2016
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 1, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share