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NCT Number: NCT06961890

Change in Hygiene and Sugar Comsuption Habits After Use of Cognitive Behavioral Therapy in Pediatric Dentistry in Twins

The objective of this study is to verify the changing habits and their maintenance after using cognitive behavioral therapy, exploring factors that may be associated with these stages and the moment in which they occur.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Oral Manifestations Adolescent Behavior Behavior Change; Cognitive Child Behavior Mouth Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Odontologia da Universidade de São Paulo

São Paulo, 05508-000, Brazil

About this study

The objective of this clinical trial is to verify the time until changing habits and their maintenance after using cognitive behavioral therapy, exploring the following factors that may be associated with these stages and the moment in which they occur:

  • Evaluate the cost-effectiveness of guidance based on cognitive behavioral therapy in relation to changes aimed at oral hygiene and diet habits, through a before and after study;
  • Investigate individual and contextual preferences associated with adherence and maintenance of behaviors associated with oral health (diet and oral hygiene) through a Discrete Choice Experiment (DCE)
  • Measure the effect of retaining hygiene and diet guidance on pairs who did not submit the calendar and on those who submitted the calendar.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Twin children born at the Hospital de Clínicas de São Paulo between 2007 and 2014;
  • Children whose mothers were followed up at the Multiple Pregnancy Unit;
  • Guardians who sign the informed consent form;
  • Children who sign the assent form.

Exclusion criteria

  • Children whose families that cannot be contacted by phone call, email, or social media;
  • Children with medical or psychological conditions that prevent safe participation in the dental research.

Treatment and study plan

Principals of cognitive behavioral therapy on guided changing hygiene and sugar comsuption habits

Behavioral

The twin pairs will also receive guidance on healthy sugar consumption and oral hygiene habits, as the first intervention among the dental interventions received. For the baseline assessment, each participant answered a questionnaire about their diet the day before and about oral hygiene, in addition to demonstrating how they perform it. Thus, the cognitive behavioral theory was applied, so that the participant can record the goals achieved weekly and monthly.

Primary outcomes

  1. Changing hygiene habits and sugar consumption in children and adolescents

    Time frame: 6 months

    Assessed using a 12-point checklist performed at baseline and at 6 month follow-ups

Secondary outcomes

  1. Preference for attributes associated with adherence to oral health-related behavior

    Time frame: 24 months

    It will be measured after 12 months of the intervention (guidance and motivation) applied to the twins through a Discrete Choice Experiment

  2. Maintenance hygiene habits and sugar consumption in children and adolescents

    Time frame: 12, 18, 24 months

    Assessed using a 12-point checklist performed at baseline and at 12, 18 and 24 month follow-ups, in which it will be assessed whether there was improvement, worsening or return to initial conditions.

Other outcomes

  1. Costs associated with the initial intervention that resulted in the effect of habit change

    Time frame: 24 months

    For the costs, the direct and indirect costs necessary for the intervention carried out at baseline and at the 6, 12, 18 and 24 month follow-ups were considered

  2. Visual attention metrics

    Time frame: 24 months

    Examples of metrics evaluated will be viewing time, fixations, saccades, among others, which will be measured by the eye-tracking device, during the use of images, videos and demonstrations in models during the evaluation process. Visual reports such as gaze plots (gaze plots) and heat maps (areas of greatest gaze fixation - heatmaps) will also be analyzed.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Acronym: CARDEC-BC

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
May 8, 2025
Registry last updated
May 8, 2025

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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