Dental Caries in ChildrenNCT04231383

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

An observational study of Dental Caries in Children, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 3 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries in Children
What is being tested?: dental caries, growth parametres
Type of treatment: Pill or oral medicine
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Aug 2019to 15 Jun 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 6 years
All sexes
Healthy volunteers accepted
Child

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

Who may be able to join

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

Show all 9Show fewer

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Basak Gunay
Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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

Conditions: Dental Caries in Children
Being tested: dental caries, growth parametres
Keywords: Dental caries, IGF-1, IGFBP-3, anthropometry, sleeping
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 6 months after dental treatment

Secondary outcomes (6)

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
Measured: before dental treatment
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
Measured: a week after dental treatment
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
Measured: 6 months after dental treatment
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
Measured: before dental treatment
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
Measured: a week after dental treatment
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
Measured: 6 months after dental treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201915 Jun 2020

First posted18 Jan 2020
Study start1 Aug 2019
Primary completion15 Apr 2020 (estimated)
Study completion15 Jun 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04231383
Sponsor's protocol ID: 8.2019/7
Status last verified: Jan 2020
First submitted: 14 Jan 2020
Last updated: 18 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 22928903
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.
PubMed 15885810
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.
PubMed 23731717

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Not yet recruiting
Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial
Prevention of Dental Caries
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries

All Dental Caries in Children trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Relationship Between Dental Caries-related Pain and Inflammation and Growth Parameters in Preschool Children
ClinicalTrials.gov ID: NCT04231383
Acronym / sponsor ID: 8.2019/7
Conditions: Dental Caries in Children
Keywords: Dental caries, IGF-1, IGFBP-3, anthropometry, sleeping
Study type: Observational
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Bezmialem Vakif UniversityUniversity, hospital or other
Study start: 1 Aug 2019 (actual)
Primary completion: 15 Apr 2020 (estimated)
Study completion: 15 Jun 2020 (estimated)
First posted: 18 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Observational model: Case-control
Time perspective: Prospective

Who may qualify

Ages: 3 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
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

Key inclusion criteria (9 listed)

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)

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dental caries, growth parametresThe 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.	Other	–

Primary outcome

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.
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 secondary outcomes

Children's Sleep Habits Questionnaire
Time frame: before dental treatment
Children's Sleep Habits Questionnaire
Time frame: a week after dental treatment
Children's Sleep Habits Questionnaire
Time frame: 6 months after dental treatment
Early Childhood Oral Health Impact Scale
Time frame: before dental treatment
Early Childhood Oral Health Impact Scale
Time frame: a week after dental treatment
Early Childhood Oral Health Impact Scale
Time frame: 6 months after dental treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Background: PubMed 22928903Alkarimi 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.
Background: PubMed 15885810Ersoy 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.
Background: PubMed 23731717Duijster 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.
Individual participant dataSharing planned: Undecided

Related trials for Dental Caries in Children

Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Not yet recruiting
Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial
Prevention of Dental Caries
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Basak Gunay principal investigator

Bezmialem Vakif University

Mustafa Sarp Kaya study director

Bezmialem Vakif University

Ilker Tolga Ozgen study chair

Bezmialem Vakif University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Caries in Children, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Growth parameters (time frame: before dental treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04231383, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.