NCT04231383

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

January 14, 2020

Last Update Submit

January 14, 2020

Conditions

Dental Caries in Children

Keywords

Dental cariesIGF-1IGFBP-3anthropometrysleeping

Outcome Measures

Primary Outcomes (2)

  • Growth parameters

    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

    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 Outcomes (6)

  • Children's Sleep Habits Questionnaire

    before dental treatment

  • Children's Sleep Habits Questionnaire

    a week after dental treatment

  • Children's Sleep Habits Questionnaire

    6 months after dental treatment

  • Early Childhood Oral Health Impact Scale

    before dental treatment

  • Early Childhood Oral Health Impact Scale

    a week after dental treatment

  • +1 more secondary outcomes

Interventions

dental caries, growth parametresOTHER

The comparison of growth parameters before and after 6 months of treatment of dental caries will be compared. Children's Sleep Habits Questionnaire and Early Childhood Oral Health Impact Scale will be compared before and at the 6th month of dental treatment.

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basak Gunay

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Alkarimi HA, Watt RG, Pikhart H, Jawadi AH, Sheiham A, Tsakos G. Impact of treating dental caries on schoolchildren's anthropometric, dental, satisfaction and appetite outcomes: a randomized controlled trial. BMC Public Health. 2012 Aug 29;12:706. doi: 10.1186/1471-2458-12-706.

    PMID: 22928903BACKGROUND

  • Ersoy B, Yuceturk AV, Taneli F, Urk V, Uyanik BS. Changes in growth pattern, body composition and biochemical markers of growth after adenotonsillectomy in prepubertal children. Int J Pediatr Otorhinolaryngol. 2005 Sep;69(9):1175-81. doi: 10.1016/j.ijporl.2005.02.020.

    PMID: 15885810BACKGROUND

  • Duijster D, Sheiham A, Hobdell MH, Itchon G, Monse B. Associations between oral health-related impacts and rate of weight gain after extraction of pulpally involved teeth in underweight preschool Filipino children. BMC Public Health. 2013 Jun 3;13:533. doi: 10.1186/1471-2458-13-533.

    PMID: 23731717BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Basak Gunay

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

  • Mustafa Sarp Kaya

    Bezmialem Vakif University

    STUDY DIRECTOR

  • Ilker Tolga Ozgen

    Bezmialem Vakif University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research asistant

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

August 1, 2019

Primary Completion

April 15, 2020

Study Completion

June 15, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

TU(1)