- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04231383
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
-
-
-
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
- (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,
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:
- 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
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
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
- 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.
- 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.
- 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.
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.
Clinical Trials on Dental Caries in Children
-
Children's Hospital ColoradoRecruitingDental Caries in Children | Dental DiseasesUnited States
-
Stephanie ShimizuUniversity of Southern CaliforniaRecruitingDental Caries in Children | Dental Caries | Dental Caries Class IIUnited States
-
University of GlasgowMinistry of Health, Saudi ArabiaRecruiting
-
University of Sao PauloNot yet recruitingDental Caries in Children | Dental CariesBrazil
-
Suez Canal UniversityCompletedDental Caries in ChildrenEgypt
-
Advantage Silver Dental Arrest, LLCActive, not recruitingDental Caries in ChildrenUnited States Minor Outlying Islands
-
Al-Azhar UniversityActive, not recruitingDental Caries in ChildrenEgypt
-
Ahram Canadian UniversityCompletedDental Caries in ChildrenEgypt
-
TC Erciyes UniversityCompleted
-
Universidad IberoamericanaUniversity of Copenhagen; Colgate Palmolive; Borrow Foundation; Hospital General...CompletedDental Caries in Children | Dental CariesDominican Republic
Clinical Trials on dental caries, growth parametres
-
Khartoum Centre for Research and Medical TrainingCompletedDental Caries in ChildrenSudan
-
Selcuk UniversityCompleted
-
Wroclaw Medical UniversityCompletedCaries,Dental | Aerosol DiseasePoland
-
Cairo UniversityUnknownBlack Stain Dental, Dental Black Stain, Black Stain*, Black Stains, Tooth Stains
-
NORCE Norwegian Research Centre ASHordaland County CouncilCompletedDental Polymer Based Filling MaterialNorway
-
Kompetansesenteret Tannhelse Midt (TkMidt)Karolinska Institutet; University of Bergen; Norwegian University of Science... and other collaboratorsActive, not recruiting
-
Universidade Federal do Rio de JaneiroRio de Janeiro State UniversityUnknownDental Caries
-
University of Sao PauloCompleted
-
University of Sao PauloCompletedQuality of Life | Anxiety | Dental CariesBrazil
-
King's College Hospital NHS TrustAdvanced Accelerator ApplicationsNot yet recruitingCarcinoid Tumor | Carcinoid Syndrome | Carcinoid Heart Disease