Evaluation of the Relationship Between Dental Caries and Growth Parameters in Preschool Children

• Conditions: Dental Caries in Children

• Registration Number: NCT04231383
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

Untreated dental caries are very common in preschool children. Pain and inflammation due to dental caries have been reported to affect eating and sleeping disorders, affecting growth and development. The aim of this study was to compare the changes in serum IGF-1 and IGFBP-3 levels, height and weight gain before and after treatment in patients with dental caries-related inflammation and pain in preschool children and to compare these children with children without dental caries. Thirty children aged between 3-6 years with dental caries with pulp were identified using ICDAS II and dmft index as the study group.30 children dental caries including pulp, will be included using the same indices as the control group. In the study group, serum IGF-1 and IGFBP-3 levels and anthropometric measurements will be determined before and at the 6th month after treatment. In the control group, serum IGF-1 and IGFBP-3 levels and anthropometric measurements will be determined at the 6th month following the first dental examination. IGF-1, IGFBP-3 and anthropometric measurements will be compared between first dental examination and 6th month values in the study and control groups, and between first dental examination and 6th month time points between the groups.

Detailed Description

In addition to growth parameters, the Children's Sleeping Habits Questionnaire and the Early Childhood Oral Health Impact Scale will be compared before the 6th month of dental treatment and compared

Study Timeline

• Study Start: 2019-08-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Last Update Submitted: 2020-01-14
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-04-15
• Study Completion: 2020-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

For study group

1. (3-6 years) preschool children
2. Children whose dental treatments are indicated under general anesthesia
3. Children with primary dentition
4. Children with early childhood caries (dmft index d≥ 3)
5. Children with symptoms of pulpitis or periapical infection in at least one tooth
6. Children with dental problems at least in the last 6 months
7. Volunteering to participate in the study. For the control group,

1- (3-6 years) preschool children 2-Children with primary dentition 3- Children without pulpitis symptoms or periapical infection during dental examination 4-Volunteering to participate in the study.

Exclusion Criteria

1. Children who do not show adequate compliance during blood sampling
2. Consent form is not signed
3. Children with chronic and systemic diseases that may affect growth and development
4. Children using anti-inflammatory
5. Patients with physical and mental disabilities
6. Patients using corticosteroids in the last 6 months
7. If a child is diagnosed with any of the these diseases during the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Growth parameters	6 months after dental treatment	In the study group, serum IGF-1 and IGFBP-3 levels and anthropometric measurements will be determined before and at the 6th month after treatment. In the control group, serum IGF-1 and IGFBP-3 levels and anthropometric measurements will be determined at the 6th month following the first dental examination. IGF-1, IGFBP-3 and anthropometric measurements will be compared between first dental examination and 6th month values in the study and control groups, and between first dental examination and 6th month time points between the groups.

Secondary Outcome Measures

Name	Time	Method
Children's Sleep Habits Questionnaire	6 months after dental treatment	In the study group Children's Sleep Habits Questionnaire will be compared before, after the a week and 6th month of dental treatment.In the control group Children's Sleep Habits Questionnaire will be compared before, after the a week and 6th month of dental treatment
Early Childhood Oral Health Impact Scale	6 months after dental treatment	n the study Early Childhood Oral Health Impact Scale will be compared before, after the a week and 6th month of dental treatment.In the control group Early Childhood Oral Health Impact Scale will be compared before, after the a week and 6th month of dental treatment

Trial Locations

Locations (1)

Basak Gunay; 🇹🇷 Istanbul, Turkey