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Dental AnxietyNCT04338854

Dental Anxiety in Children and Salivary Cortisol Levels

A study testing Restorative Treatment in people with Dental Anxiety, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: This study aimed to assess whether pediatric dental anxiety is due to the day of dental appointment, to the dental chair, or to the dental treatment procedure during the course of the first dental treatment in children. Read more about this study

Who is it for?
Ages 7 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Dental Anxiety
What is being tested?
Restorative Treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2017to 25 Jul 2018
Phase
Interventional
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 7 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • They were apparently healthy and had no previous experience of dental treatment
  • In terms of the standardization of the groups, only the children who were compatible with Frankl-3 or 4 classes were included in the study.
  • The patients were divided into groups taking into consideration the requirements of having no pain, abscess, fistula and no need for dental treatment requiring urgent intervention.

Who cannot join

  • Patients, who did not meet the inclusion criteria for the study, who did not want to participate voluntarily, who ate and drank something 1 hour before the appointment, who used medication in the last 7 days, who used medication that may affect the salivary flow in the last 60 days or who left the dental treatment incomplete, were not included in the study.
  • Children with Farnkl-1 and -2 classes had negative compliance to treatment and therefore they were not included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University

    Malatya, 44280

Other trials in Turkey (Türkiye)

About this study

Official title: The Evaluation of The Effect of Routine Treatments Administrated in Pedodontics Clinics on Dental Anxiety in Children and Salivary Cortisol Levels

Objective: This study aimed to assess whether pediatric dental anxiety is due to the day of dental appointment, to the dental chair, or to the dental treatment procedure during the course of the first dental treatment in children.

Study Design: Salivary cortisol samples were taken on three sequential days (pre-treatment, treatment and post-treatment days) and during the beginning and at ~15th minute of treatment, and at 15th minute post-treatment in children. They received (n=135; 15/group) root-canal treatment, pulpotomy, two- and one-surface restoration with and without local anesthesia; fluoride (with arch tray or cotton roll) or fissure sealant applications. Heart rate and SpO2 (peripheral oxygen saturation ) were monitored and The Facial Image Scale (FIS) and Children's Fear Survey Schedule-Dental subscales (CFSS-DS) were filled.

Read the detailed description

The study was carried out following the approval by the local ethics committee (Malatya Clinical Studies Ethics Committee, 2017/76), and informed consent was signed by the parents. A total of 135 children (69 females 51.1%, 66 males 49.9%), aged 7-8 years (7.37±0.48 years), were admitted to Inonu University Faculty of Dentistry Department of Pediatric Dentistry. The study was planned with 135 children with 15 children in each group. For that purpose 9 groups were formed as 6 restorative and 3 protective applications. The restorative treatment groups included procedures with- and without-local anesthesia (LA). Procedures with LA included the groups as root canal treatment, pulpotomy, two-surface restoration and one-surface restoration. Procedures without LA included the groups as two-surface restoration and one-surface restoration. The protective application groups included the groups as fluoride application (by disposable arch tray or by cotton roll) and fissure sealant. The diagnosis and treatments were carried out by the same dentist (BA).Frankl's Behaviours Rating Scale (FBRS) is a method that is frequently used in studies based on the rating of behaviours. Children's attitudes during the dental examination were evaluated using FBRS. Behaviours of the child are examined in four groups in FBRS: definitely negative (Frankl-1), negative (Frankl-2), positive (Frankl-3), and definitely positive (Frankl-4).In terms of the standardization of the groups, only the children who were compatible with Frankl-3 or 4 classes were included in the study. Children with Farnkl-1 and -2 classes had negative compliance to treatment and therefore they were not included in the study. The patients were grouped according to treatment needs. Each patient who participated in the study was informed about the treatment to be applied to him/her and the measurements to be performed by using the tell-show-apply behavior method. Furthermore, the child informed the dentist about any discomforting stimuli by "raising his/her left hand up" and the dentist stopped when he/she received this warning. In the groups treated with local anesthesia, banana or strawberry flavored topical anesthetic gel (Vision Dental Pat Gel, WP Dental, Germany) that children might like was applied first. Then, the local anesthetic solution [Ultracain D-S ampoule (40 mg articain + 0.012 mg epinephrine) Aventis Pharma, Istanbul, Turkey] was injected by the traditional method with the help of a 2 cc set inject plastic dental injector (Tıbset Sterile Medical Equipment Industry Istanbul, Turkey). Only conventional root canal treatment and extirpation were planned for the children included in the root canal treatment group in the measurement session. In the groups to be treated with pulpotomy, it was noted that at least one of the approximal surfaces of the teeth had decay and iron sulfate (ViscoStat®, UltraDent, South Jordan, USA) was used as pulpotomy material. A Tofflemire matrix retainer and 0.05 mm thick matrix band (Hahnenkratt, Königsbach-Stein, Germany) were used in groups with a two-surface cavity. 2% NaF (Polimo® IMICRYL, Konya, Turkey) was preferred in groups who received fluoride application.

An aerator and micromotor were used as cavity preparation in the restorative treatment groups. Only the micromotor was used for polishing purposes in the protective treatment groups. FIS (Facial Image Scale) was assessed at three stages: at the moment they sat in the dental chair, 15 minutes after the start of the treatment, and 15 minutes after the end of the treatment. From the moment the patient sat in the dental chair, the probe of the bed-side monitor was attached to the patient's left index finger, and his/her heart rate and SpO2 (peripheral oxygen saturation ) of were monitored during the treatment period and the data were recorded. After the treatment of the patients was completed in that appointment, the CFSS-DS (Children's Fear Survey Schedule-Dental Subscales) was filled in by the patients under the supervision of their parents. In the mornings, 3 salivary samples were taken from the patients by their parents in the home environment, i.e. one day before the treatment, on the day of treatment and one day after the treatment. The non-stimulated total saliva was collected from the patients. The parents were warned about the fact that all of the three salivary samples should be taken at the 30th minute after awakening, between 07:00 and 07:30 am. Eating, drinking, brushing the teeth and using dental care products were not allowed. During the treatment period in the clinic, salivary samples were taken between 09.00 and 11.00 am. Saliva samples were taken in 3 stages, i.e. at the beginning of the treatment, at the 15th minute of the treatment, and 15 minutes after the end of the treatment. Sampling at 15th minute of the treatment process was standardized to correspond to the cavity with an aerator (at the enamel level) in restorative treatment groups and to the stage of polishing procedure with a micro motor in protective treatment groups. These measures were taken to prevent the saliva from contaminating the cavity.

Conditions
Dental Anxiety
Being tested
Restorative Treatment
Keywords
dental anxiety, cortisol, procedure

What participants receive

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

  • Restorative TreatmentProcedure or surgery

    Also called Protective Application

    9 groups were formed as 6 restorative and 3 protective applications. The restorative treatment groups included procedures with- and without-local anesthesia (LA). Procedures with LA included the groups as root canal treatment, pulpotomy, two-surface restoration and one-surface restoration. Procedures without LA included the groups as two-surface restoration and one-surface restoration. The protective application groups included the groups as fluoride application (by disposable arch tray or by cotton roll) and fissure sealant.

Study groups in NCT04338854
Study groupRoleWhat they receive
Root canal treatmentExperimentalIt's one of the restorative groups with LA (Local Anesthesia). An aerator and micromotor were used as cavity preparation in this group. Only conventional root canal treatment and extirpation were planned for the children included in the root canal treatment group in the measurement session.
Receives: Procedure: Restorative Treatment
Pulpotomy treatmentExperimentalIt's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group. it was noted that at least one of the approximal surfaces of the teeth had decay and iron sulfate (ViscoStat®, UltraDent, South Jordan, USA) was used as pulpotomy material
Receives: Procedure: Restorative Treatment
two-surface restoration with Local AnesthesiaExperimentalIt's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group. A Tofflemire matrix retainer and 0.05 mm thick matrix band (Hahnenkratt, Königsbach-Stein, Germany) were used in groups with a two-surface cavity.
Receives: Procedure: Restorative Treatment
one surface restoration with Local AnesthesiaExperimentalIt's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group.
Receives: Procedure: Restorative Treatment
two-surface restoration without Local AnesthesiaExperimentalAn aerator and micromotor were used as cavity preparation in this group. A Tofflemire matrix retainer and 0.05 mm thick matrix band (Hahnenkratt, Königsbach-Stein, Germany) were used in groups with a two-surface cavity.
Receives: Procedure: Restorative Treatment
one surface restoration without Local AnesthesiaExperimentalAn aerator and micromotor were used as cavity preparation in this group.
Receives: Procedure: Restorative Treatment
fluoride application by disposable arch trayExperimentalIt's one of the protective groups.Only the micromotor was used for polishing purposes in the protective treatment groups. 2% NaF (Polimo® IMICRYL, Konya, Turkey) was preferred in groups who received fluoride application.
Receives: Procedure: Restorative Treatment
fluoride application by cotton rollExperimentalIt's one of the protective groups. Only the micromotor was used for polishing purposes in the protective treatment groups 2% NaF (Polimo® IMICRYL, Konya, Turkey) was preferred in groups who received fluoride application.
Receives: Procedure: Restorative Treatment
Fissure Sealant groupExperimentalIt's one of the protective groups. Only the micromotor was used for polishing purposes in the protective treatment groups.
Receives: Procedure: Restorative Treatment

What is being measured

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

  1. Salivary cortisol levels at home

    the day before treatment

    Measured: 30th minute after awakening, between 07:00 and 07:30 am.

  2. Salivary cortisol levels at home

    the treatment day

    Measured: 30th minute after awakening, between 07:00 and 07:30 am.

  3. Salivary cortisol levels at home

    the day after treatment

    Measured: 30th minute after awakening, between 07:00 and 07:30 am.

  4. Salivary cortisol levels at clinic

    the treatment day

    Measured: beginning of the treatment, between 09:00 and 11:00 am.

  5. Salivary cortisol levels in clinic

    the treatment day

    Measured: 15th minute of the treatment, between 09:00 and 11:00 am.

  6. Salivary cortisol levels in clinic

    the treatment day

    Measured: 15th minute post treatment, between 09:00 and 11:00 am.

Timeline

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

  1. First posted8 Apr 2020
  2. Study start15 Dec 2017
  3. Primary completion20 Apr 2018
  4. Study completion25 Jul 2018

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04338854
Sponsor's protocol ID
2017-840
Status last verified
Apr 2020
First submitted
10 Feb 2020
Last updated
8 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yfanti K, Kitraki E, Emmanouil D, Pandis N, Papagiannoulis L. Psychometric and biohormonal indices of dental anxiety in children. A prospective cohort study. Stress. 2014 Jul;17(4):296-304. doi: 10.3109/10253890.2014.918602. Epub 2014 May 27.

    PubMed 24766350

Questions about this trial

What is this clinical trial studying?

A study testing Restorative Treatment in people with Dental Anxiety, run by Inonu 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 8 Apr 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Salivary cortisol levels at home (time frame: 30th minute after awakening, between 07:00 and 07:30 am.). The study lists 6 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 NCT04338854, which also lists 1 linked publication.

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 8 Apr 2020.

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