A 8-month Study on the Use of Intra-oral Camera and Text Messages on Gingivitis Control

Gingivitis Clinical Trial

Official title:

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439969
• Other study ID #: Ethic Committee Doc. No. 6/14
• Status: Completed
• Phase: N/A
• First received: February 13, 2018
• Last updated: February 19, 2018
• Start date: June 1, 2014
• Est. completion date: November 30, 2016

Study information

• Verified date: February 2018
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: November 30, 2016
• Est. primary completion date: February 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms
• Gingivitis

Intervention

Device:
• Mobile Text Messages
Dental inter-proximal control with floss holder and receiving 16 SMS during 4 months.
• Intra Oral Camera
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Lisbon

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from BOMP (Bleeding on Marginal Probing) at 4 & 8 months	Gingival bleeding Index	Baseline, 4 months & 8 months
Secondary	HAPA (Health Action Process Approach) behavioral variables questionnaire.	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.
Secondary	SMS (Short Messages Service) text messages opinion questionnaire	Opinion about receiving SMS and how can it influence the appointment.	At 4 months.
Secondary	Intra Oral Camera opinion questionnaire	Opinion about receiving Intra Oral camera and how can it influence the appointment.	At 4 and 8 months.
Secondary	Self-report Dental Hygiene Behaviors questionnaire.	Level of toothbrushing and dental floss frequency.	Baseline, 4 and 8 months.