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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04231383
• Other study ID #: 8.2019/7
• Status: Active, not recruiting
• Start date: August 1, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: January 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Other:
• dental caries, growth parametres
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.

Locations

Country	Name	City	State
Turkey	Basak Gunay	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View Citation

Ersoy B, Yücetürk 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Children's Sleep Habits Questionnaire	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
Secondary	Children's Sleep Habits Questionnaire	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
Secondary	Children's Sleep Habits Questionnaire	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
Secondary	Early Childhood Oral Health Impact Scale	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
Secondary	Early Childhood Oral Health Impact Scale	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
Secondary	Early Childhood Oral Health Impact Scale	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