- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03439969
A 8-month Study on the Use of Intra-oral Camera and Text Messages on Gingivitis Control
February 19, 2018 updated by: Mario Rui Araújo, University of Lisbon
The Whole is Greater Than the Sum of Its Parts. "A 8-month Randomised Controlled Trial on the Use of Intra-oral Camera and Text Messages on Gingivitis Control"
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Dental hygiene behaviours are of paramount importance for controlling gingival health.
There is evidence on the use of IOC and of text messages in boosting motivation, sustainability and clinical efficacy of dental hygiene behaviors.
Orchestrating these two technologies is expected to create a coaction effect which could improve behavior change interventions, but the effectiveness of such strategy needs to be inspected.
Study Type
Interventional
Enrollment (Actual)
233
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Gingivitis BOMP > 0.5 20 teeth (minimum 5 per quadrant) > 18 years old
Exclusion Criteria:
periodontitis (pockets >3), smoking, orthodontics, pregnancy removable partial dentures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
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.
|
|
Experimental: Intra Oral Camera
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.
|
SPT - Appointment with Intra-Oral Camera
|
Experimental: Mobile Text Messages
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.
|
Dental inter-proximal control with floss holder and receiving 16 SMS during 4 months.
|
Experimental: Intra Oral Camera and Text Messages
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.
|
SPT - Appointment with Intra-Oral Camera
Dental inter-proximal control with floss holder and receiving 16 SMS during 4 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from BOMP (Bleeding on Marginal Probing) at 4 & 8 months
Time Frame: Baseline, 4 months & 8 months
|
Gingival bleeding Index
|
Baseline, 4 months & 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HAPA (Health Action Process Approach) behavioral variables questionnaire.
Time Frame: Baseline, 4 & 8 months.
|
Measures adapted to oral health from previous studies with the HAPA model (Godinho et al. 2015) were used.
All the HAPA variables were evaluated using a 7 point Likert-type scale, ranging from totally disagree (1) to totally agree (7), unless otherwise stated.
|
Baseline, 4 & 8 months.
|
SMS (Short Messages Service) text messages opinion questionnaire
Time Frame: At 4 months.
|
Opinion about receiving SMS and how can it influence the appointment.
|
At 4 months.
|
Intra Oral Camera opinion questionnaire
Time Frame: At 4 and 8 months.
|
Opinion about receiving Intra Oral camera and how can it influence the appointment.
|
At 4 and 8 months.
|
Self-report Dental Hygiene Behaviors questionnaire.
Time Frame: Baseline, 4 and 8 months.
|
Level of toothbrushing and dental floss frequency.
|
Baseline, 4 and 8 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Actual)
February 28, 2015
Study Completion (Actual)
November 30, 2016
Study Registration Dates
First Submitted
February 13, 2018
First Submitted That Met QC Criteria
February 13, 2018
First Posted (Actual)
February 20, 2018
Study Record Updates
Last Update Posted (Actual)
February 22, 2018
Last Update Submitted That Met QC Criteria
February 19, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ethic Committee Doc. No. 6/14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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