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

NCT06961890 | Active Not Recruiting

• 1 other identifier: CARDEC-TWINS-BC
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Manifestations; Child Behavior; Adolescent Behavior; Change; Cognitive

Keywords

clinical study; cognitive behavioral therapy; oral health; twins; motivational guidance; preference patients

Outcome Measures

Primary Outcomes (1)

• Changing hygiene habits and sugar consumption in children and adolescents

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

  6 months

Secondary Outcomes (2)

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

  24 months

• Maintenance hygiene habits and sugar consumption in children and adolescents

  12, 18, 24 months

Other Outcomes (2)

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

  24 months

• Visual attention metrics

  24 months

Study Arms (1)

cognitive behavioral therapy

EXPERIMENTAL

All participants will receive a standardized orientation for changing oral health habits using principals of cognitive behavioral therapy

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

Interventions

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.

cognitive behavioral therapy

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Faculdade de Odontologia da Universidade de São Paulo

São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Oral Manifestations; Child Behavior; Adolescent Behavior

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Mariana M Braga

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Edgard M Crosato

  University of Sao Paulo

  STUDY DIRECTOR

• Thais GO Machado

  University of Sao Paulo

  STUDY CHAIR

• Fausto M Mendes

  University of Sao Paulo

  STUDY DIRECTOR

• Laura RA Pontes

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: June 2, 2021
• Primary Completion: September 11, 2023
• Study Completion (Estimated): August 2, 2028
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: baseline, 6M, 12M, 18M, 24M
• Access Criteria: Data will be collected on pregnancy, parental sociodemographics (age, sex), alloparental care, and twin characteristics (age, sex, zygosity), using questionnaires and registry data (birth weight, ICU stay, chorionicity, gestational age, fetal growth, complications). Caries lesions and indicators of physical, cognitive, and emotional development will be monitored. Behavioral and physiological data will be gathered before and during dental procedures. Instruments include Zygosity Questionnaire, Environmental Sensitivity, Socialization Goals, Alabama Parenting, Twin Relationship, Childhood Adversity, Quality of Life, MCDAS-f, Emotion Regulation, and identity fusion. Additional data: caries detection (ICDAS), physical (height, weight), cognitive (Raven), figure drawings, videos, facial temperature (thermal camera), voice recordings, and saliva swabs. Metadata will follow USP Open Access Policy with DOI, title, authors, keywords, funding, and deposit info.

Locations

BR (1)