NCT03439969

Brief Summary

To investigate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy, and oral hygiene mobile text messages (SMS) between appointments on clinical, behavioral and psychological parameters of patients with gingivitis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

February 13, 2018

Last Update Submit

February 19, 2018

Conditions

Keywords

GingivitisSMSText messagesBehavior changeHAPADental Hygiene

Outcome Measures

Primary Outcomes (1)

  • Change from BOMP (Bleeding on Marginal Probing) at 4 & 8 months

    Gingival bleeding Index

    Baseline, 4 months & 8 months

Secondary Outcomes (4)

  • HAPA (Health Action Process Approach) behavioral variables questionnaire.

    Baseline, 4 & 8 months.

  • SMS (Short Messages Service) text messages opinion questionnaire

    At 4 months.

  • Intra Oral Camera opinion questionnaire

    At 4 and 8 months.

  • Self-report Dental Hygiene Behaviors questionnaire.

    Baseline, 4 and 8 months.

Study Arms (4)

Control

NO INTERVENTION

Dental appointment, one hour and included activities that are normally part of a SPT (Suportive Periodontal Treatment) consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback 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 and Text Messages were not used.

Intra Oral Camera

EXPERIMENTAL

Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. 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.

Device: Intra Oral Camera

Mobile Text Messages

EXPERIMENTAL

Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback.. Participants in the SMS group further received a total of 16 messages (SMS). One per week.

Device: Mobile Text Messages

Intra Oral Camera and Text Messages

EXPERIMENTAL

Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. 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.Participants also received SMS a total of 16 messages (SMS). One per week.

Device: Mobile Text MessagesDevice: Intra Oral Camera

Interventions

Dental inter-proximal control with floss holder and receiving 16 SMS during 4 months.

Intra Oral Camera and Text MessagesMobile Text Messages

SPT - Appointment with Intra-Oral Camera * Examination and diagnosis (15 min) using Intra-oral camera. * Motivation, discussion about desired outcomes and treatment needs (using Intra-oral camera) followed by instrumentation (scaling, polishing) (30 min).

Intra Oral CameraIntra Oral Camera and Text Messages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • periodontitis (pockets \>3), smoking, orthodontics, pregnancy removable partial dentures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 26010304BACKGROUND

MeSH Terms

Conditions

BehaviorGingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The researcher was blind to the patients
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master in Health Psychology

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 20, 2018

Study Start

June 1, 2014

Primary Completion

February 28, 2015

Study Completion

November 30, 2016

Last Updated

February 22, 2018

Record last verified: 2018-02