Clinical trial NCT04231383: Evaluation of the Relationship Between Dental Caries and Growth Parameters in Preschool Children
Official title: Evaluation of the Relationship Between Dental Caries-related Pain and Inflammation and Growth Parameters in Preschool Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Caries in Children
Keywords: Dental caries
IGF-1
IGFBP-3
anthropometry
sleeping
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Growth parameters
timeFrame: before dental treatment
measure: Growth parameters
timeFrame: 6 months after dental treatment
Secondary outcomes:
measure: Children's Sleep Habits Questionnaire
timeFrame: before dental treatment
measure: Children's Sleep Habits Questionnaire
timeFrame: a week after dental treatment
measure: Children's Sleep Habits Questionnaire
timeFrame: 6 months after dental treatment
measure: Early Childhood Oral Health Impact Scale
timeFrame: before dental treatment
measure: Early Childhood Oral Health Impact Scale
timeFrame: a week after dental treatment
measure: Early Childhood Oral Health Impact Scale
timeFrame: 6 months after dental treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basak Gunay
Study officials:
affiliation: Bezmialem Vakif University
name: Basak Gunay
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Mustafa Sarp Kaya
role: STUDY_DIRECTOR
affiliation: Bezmialem Vakif University
name: Ilker Tolga Ozgen
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.