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

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04231383
Collaborator
(none)
60
1
10.5
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: dental caries, growth parametres

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of the Relationship Between Dental Caries-related Pain and Inflammation and Growth Parameters in Preschool Children
Actual Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Apr 15, 2020
Anticipated Study Completion Date :
Jun 15, 2020

Outcome Measures

Primary Outcome Measures

  1. Growth parameters [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.

  2. 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

  1. Children's Sleep Habits Questionnaire [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

  2. Children's Sleep Habits Questionnaire [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

  3. 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

  4. Early Childhood Oral Health Impact Scale [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

  5. Early Childhood Oral Health Impact Scale [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

  6. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Basak Gunay Istanbul Turkey

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Basak Gunay, research asistant, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT04231383
Other Study ID Numbers:
  • 8.2019/7
First Posted:
Jan 18, 2020
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Basak Gunay, research asistant, Bezmialem Vakif University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2020