Clinical trial NCT06961890: Change in Hygiene and Sugar Comsuption Habits After Use of Cognitive Behavioral Therapy in Pediatric Dentistry in Twins
Official title: Change in Hygiene and Sugar Comsuption Habits After Use of Cognitive Behavioral Therapy in Pediatric Dentistry in Twins
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Oral Manifestations
Child Behavior
Adolescent Behavior
Change; Cognitive
Keywords: clinical study
cognitive behavioral therapy
oral health
twins
motivational guidance
preference patients
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2025-05-08
Enrollment: 222
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changing hygiene habits and sugar consumption in children and adolescents
timeFrame: 6 months
Secondary outcomes:
measure: Preference for attributes associated with adherence to oral health-related behavior
timeFrame: 24 months
measure: Maintenance hygiene habits and sugar consumption in children and adolescents
timeFrame: 12, 18, 24 months
Other outcomes:
measure: Costs associated with the initial intervention that resulted in the effect of habit change
timeFrame: 24 months
measure: Visual attention metrics
timeFrame: 24 months
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Odontologia da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Mariana M Braga
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Edgard M Crosato
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Thais GO Machado
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Fausto M Mendes
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Laura RA Pontes
role: STUDY_CHAIR
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