Condition category
Mental and Behavioural Disorders
Date applied
05/12/2017
Date assigned
08/12/2017
Last edited
07/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Attention-Deficit Hyperactivity Disorder (ADHD) is a disorder that causes inattentiveness, hyperactivity and impulsiveness. Children with ADHD often experience additional problems including sleep and anxiety. ADHD is often treated with medications. There are only a few studies about ora-dental health of children with ADHD and these studies presented conflicting results. Children with ADHD might have higher dental fear and higher caries (cavities) risk, and associated oral and dental health variables might show differences when compared with the healthy children. Medicated children with ADHD might have higher dental fear and exhibit worse ora-dental health than the control group. The aim of this study is to determine the ora-dental health and its relation with medication and dental fear in a group of Turkish children with ADHD.

Who can participate?
Children aged 6-15 years old who are diagnosed with ADHD.

What does the study involve?
Participants are assessed for their overall dental health at the first appointment. Dental treatment needs are determined and treatment appointments are organised. According to the dental fear scale sores appropriate dental behaviour management is decided applicable during dental treatment. Oral hygiene practice and anticariogenic diet informations are given to each patient.

What are the possible benefits and risks of participating?
Participants may benefit from having detailed information about your ora-dental health, caries risk factors and preventive strategies. There are no any direct risks for the patients participating in the study.

Where is the study run from?
Istanbul University (Turkey)

When is the study starting and how long is it expected to run for?
January 2015 to December 2016

Who is funding the study?
The Research Support Unit of Istanbul University (Turkey)

Who is the main contact?
Professor Arzu Pinar Erden (Scientific)
apinar@istanbul.edu.tr

Trial website

Contact information

Type

Scientific

Primary contact

Prof Arzu Pinar Erdem

ORCID ID

http://orcid.org/0000-0002-3940-4761

Contact details

Istanbul University
Faculty of Dentistry
Department of Pedodontics
Istanbul
34093
Turkey
+212 4142020 30283
apinar@istanbul.edu.tr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

project no. 2172.

Study information

Scientific title

Examining the ora-dental health and its relation with medication and dental fear in a group of Turkish children with attention deficit hyperactivity disorder

Acronym

ADHD

Study hypothesis

The objective of this study is to determine the ora-dental health and its relation with medication and dental fear in a group of Turkish children with ADHD.

Hypothesis:
1. Children with ADHD might have higher dental fear and higher caries risk, and associated oral and dental health variables might show differences when compared with the healthy children.
2. The medicated children with ADHD might have higher dental fear and exhibit worse ora-dental health than the control group.

Null hypothesis:
The children with ADHD (medicated or not) didn’t have dental fear and show similar ora-dental health like healthy children.

Ethics approval

Istanbul University Clinical Research Ethics Committee, 22/08/2014, ref: no: 1281

Study design

Observational cross-sectional comparative research

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

The objective of this study was to determine the ora-dental health and its relation with medication and dental fear in a group of Turkish children with ADHD.

Intervention

Participants are recruited from a clinical sample of children aged 6-15 years who are consecutively referred to an outpatient children and adolescents psychiatry clinic in Istanbul, Turkey - between 04/05/2015 and 30/03/2016 and diagnosed with ADHD. ADHD diagnosis is made according to DSM-V (American Psychiatric Association, 2013) (25) criteria and healthy children (who didn’t have any systemic disorder, mental or any other psychological diorders) constituted as non-ADHD (control group).

Before initiation of the study, participant consent forms are received from children and their parents who accepted to participate in the study. A similar age and gender distribution is taken into account in the control group. The exclusion criteria were the presence of confounding medical history, a severe mental health or any other psychological disorders.

After psychological assessment, participants are referred to the Istanbul University Faculty of Dentistry, Department of Pedodontics for oral and dental examinations.

First, the levels of dental fear of children are determined with “The Dental Subscale of Childrens Fear Survey Schedule (CFSS-DS)” in the pediatric dental clinic. The CFSS-DS consists of 15 items, related to the different aspects of dental treatment. The possible item responses range from 1 (not afraid at all) to 5 (very afraid), giving a range of possible scores of 15–75. Points between 15-32 indicate low, 32-38 refer to moderate level of fear and >39 were defined as dentally anxious.

Additionally, several factors that could be related to the caries risk are questioned through a survey, including socioeconomical status, frequency of dental follow-up, frequency of sugary snacks intake, fluoride program, frequency of toothbrushing, medication and the persistence of parafunctional habits (bruxism, tumbsucking, pacifier sucking, nail biting etc). The questionnaire is replied with the parents/children by face to face interviewing.

After the surveys had been completed, stimulated saliva samples are collected and laboratory study and culture procedures were performed in Istanbul University, Faculty of Dentistry, Department of Microbiology. Salivary flow rate, buffering capacity, MS, LB, and yeasts were counted. The saliva sample was collected before the dental examination, and participants were asked to refrain from eating, drinking, tooth brushing, and rinsing their mouths for at least 1 h before saliva collection.

Oral and dental health evaluation were performed by an experienced pediatric dentist, using a dental mirror, dental explorer, and a World Health Organization (WHO) periodontal probe. df(t)/df(s); DMF(T)/DMF(S) index score, the presence of white spot lesions, periodontal status (Silness Löe plaque index, bleeding index, probing pocket depth) were recorded.

Plaque index was scored as (0= PI < 0.4, 1= PI =0.4-1, 2= PI =1.1-2.0, 3= PI > 2), saliva flow rate (SFR) as (0= SFR > 1.1 ml, 1=SFR=0.9-1.1ml, 2=SFR= 0.5-0.9 ml, 3= SFR < 0.5 ml ), buffering capacity (BC) as (0=BC= pH < 6, 1=BC= 4.5-5.5, 2=BC= pH < 4), mutans streptococci(MS) as (0=MS= Low < 105 cfu/ml, 1= MS=Medium 105-106 cfu/ml, 2=MS= High > 106 cfu/ml ), lactobacillus (LB) as (0=LB= Low < 104 cfu/ml, 1=LB= Medium 104-105 cfu/ml, 2=LB= High > 105 cfu/ml) and candida (C) as (0= C=Low < 103 cfu/ml, 1=C= Medium 103-104 cfu/ml, 2= C=High > 104 cfu/ml).

All data is entered into a computer-based program, the Cariogram, and caries risk profiles of all children were determined as previously described (27,28). The following five Cariogram categories were used: “very low risk” = 81-100% chance to avoid caries; “low risk” = 61-80% chance to avoid caries; “moderate risk” = 41-60% chance to avoid caries; “high risk” = 21-40% chance to avoid caries; and “very high risk” = 0-20% chance to avoid caries.

Ora-dental health variables are compared with the children with ADHD and without ADHD. The groups were also analyzed in accordance with dental fear and medication.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Levels of dental fear are measured using the CFSS-DS at the first appoinment for dental examination.
2. Caries risk are measured using a questionnaire consisting several factors that could be related to the caries risk were questioned through a survey, including socioeconomical status, frequency of dental follow-up, frequency of sugary snacks intake, fluoride program, frequency of toothbrushing, medication and the persistence of parafunctional habits (bruxism, tumbsucking, pacifier sucking, nail biting etc) was replied with the parents/children by face to face interviewing at the first appoinment for dental examination
3. Plaque index values were measured using Silness Löe plaque index at the first appoinment for dental examination
4. Bleeding is measured using the modified Sulcus Bleeding index, probing pocket depth at the first appoinment for dental examination
5. Caries activity are measured using the DMF(T)/DMF(S) indexes (WHO), saliva flow rate, saliva buffering capacity, MS, LB, yeast counts) was applied at the first appoinment for dental examination
6. Caries risk profiles of all children are determined with a computer-based program, the Cariogram, at the first appoinment for dental examination

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

02/01/2015

Overall trial end date

30/12/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Children aged 6-15 years who are consecutively referred to an outpatient children and adolescents psychiatry clinic in Istanbul, Turkey - between 04/05/2015 and 30/03/2016
2. Diagnosed with ADHD. ADHD diagnosis is made according to DSM-V (American Psychiatric Association, 2013) (25) criteria and healthy children (who didn’t have any systemic disorder, mental or any other psychological diorders) constituted as non-ADHD (control group)
3. Consent to participate from children and their parents

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

A total of 117 children was included in the study with 58 children aged between 6-15 years, diagnosed with ADHD and 59 healthy children who have no any psychiatric diagnosis and systemic disorders.

Participant exclusion criteria

1. The presence of confounding medical history
2. A severe mental health or any other psychological disorders

Recruitment start date

04/05/2015

Recruitment end date

30/03/2016

Locations

Countries of recruitment

Sudan, Suriname, Turkey

Trial participating centre

Istanbul University
Faculty of Dentistry Department of Pedodontics
Istanbul
34093
Turkey

Trial participating centre

Bakirkoy Training and Research Hospital for Mental Health and Neurological Disorders
Department of Child and Adolescent Psychiatry
Istanbul
34147
Turkey

Trial participating centre

Yedikule Surp Pırgiç Armenian Hospital
Clinical Psychology Department
Istanbul
34020
Turkey

Sponsor information

Organisation

Istanbul University

Sponsor details

Faculty of Dentistry
Department of Pedodontics
Istanbul
34093
Turkey
+212 414 2020
apinar@istanbul.edu.tr

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

The Research Support Unit of Istanbul University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned to submit to Nigerian Journal of Clinical Practice.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Assoc. Prof. Arzu Pınar-Erdem aperdem@gmail.com.

Intention to publish date

30/12/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes