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

January 14, 2020 updated by: Basak Gunay, Bezmialem Vakif University

Evaluation of the Relationship Between Dental Caries-related Pain and Inflammation and Growth Parameters in Preschool Children

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Basak Gunay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth parameters
Time Frame: before 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.
before dental treatment
Growth parameters
Time Frame: 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.
6 months after dental treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Sleep Habits Questionnaire
Time Frame: before 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
before dental treatment
Children's Sleep Habits Questionnaire
Time Frame: a week 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
a week after dental treatment
Children's Sleep Habits Questionnaire
Time Frame: 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
6 months after dental treatment
Early Childhood Oral Health Impact Scale
Time Frame: before 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
before dental treatment
Early Childhood Oral Health Impact Scale
Time Frame: a week 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
a week after dental treatment
Early Childhood Oral Health Impact Scale
Time Frame: 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
6 months after dental treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Basak Gunay, Bezmialem Vakif University
  • Study Director: Mustafa Sarp Kaya, Bezmialem Vakif University
  • Study Chair: Ilker Tolga Ozgen, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

April 15, 2020

Study Completion (Anticipated)

June 15, 2020

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8.2019/7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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