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Completed

NCT Number: NCT03439969

A 8-month Study 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.

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Key information

Conditions

Behavior and Behavior Mechanisms Behavior Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Text Messages

Device

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

Intra Oral Camera

Device

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).

Primary outcomes

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

    Time frame: Baseline, 4 months & 8 months

    Gingival bleeding Index

Secondary outcomes

  1. 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.

  2. SMS (Short Messages Service) text messages opinion questionnaire

    Time frame: At 4 months.

    Opinion about receiving SMS and how can it influence the appointment.

  3. 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.

  4. Self-report Dental Hygiene Behaviors questionnaire.

    Time frame: Baseline, 4 and 8 months.

    Level of toothbrushing and dental floss frequency.

Sponsors and collaborators

Lead sponsor

University of Lisbon

Other

Registry information

Official study 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"

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 20, 2018
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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