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Dental Anxiety in Children and Salivary Cortisol Levels

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Restorative Treatment
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dental Anxiety focused on measuring dental anxiety, cortisol, procedure

Eligibility Criteria

7 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Root canal treatment

Pulpotomy treatment

two-surface restoration with Local Anesthesia

one surface restoration with Local Anesthesia

two-surface restoration without Local Anesthesia

one surface restoration without Local Anesthesia

fluoride application by disposable arch tray

fluoride application by cotton roll

Fissure Sealant group

Arm Description

It'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.

It'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

It'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.

It's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group.

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.

An aerator and micromotor were used as cavity preparation in this group.

It'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.

It'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.

It's one of the protective groups. Only the micromotor was used for polishing purposes in the protective treatment groups.

Outcomes

Primary Outcome Measures

Salivary cortisol levels at home
the day before treatment
Salivary cortisol levels at home
the treatment day
Salivary cortisol levels at home
the day after treatment
Salivary cortisol levels at clinic
the treatment day
Salivary cortisol levels in clinic
the treatment day
Salivary cortisol levels in clinic
the treatment day

Secondary Outcome Measures

Full Information

First Posted
February 10, 2020
Last Updated
April 6, 2020
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT04338854
Brief Title
Dental Anxiety in Children and Salivary Cortisol Levels
Official Title
The Evaluation of The Effect of Routine Treatments Administrated in Pedodontics Clinics on Dental Anxiety in Children and Salivary Cortisol Levels
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
July 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
Keywords
dental anxiety, cortisol, procedure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Root canal treatment
Arm Type
Experimental
Arm Description
It'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.
Arm Title
Pulpotomy treatment
Arm Type
Experimental
Arm Description
It'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
Arm Title
two-surface restoration with Local Anesthesia
Arm Type
Experimental
Arm Description
It'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.
Arm Title
one surface restoration with Local Anesthesia
Arm Type
Experimental
Arm Description
It's one of the restorative groups with LA (Local Anesthesia).An aerator and micromotor were used as cavity preparation in this group.
Arm Title
two-surface restoration without Local Anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
one surface restoration without Local Anesthesia
Arm Type
Experimental
Arm Description
An aerator and micromotor were used as cavity preparation in this group.
Arm Title
fluoride application by disposable arch tray
Arm Type
Experimental
Arm Description
It'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.
Arm Title
fluoride application by cotton roll
Arm Type
Experimental
Arm Description
It'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.
Arm Title
Fissure Sealant group
Arm Type
Experimental
Arm Description
It's one of the protective groups. Only the micromotor was used for polishing purposes in the protective treatment groups.
Intervention Type
Procedure
Intervention Name(s)
Restorative Treatment
Other Intervention Name(s)
Protective Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Salivary cortisol levels at home
Description
the day before treatment
Time Frame
30th minute after awakening, between 07:00 and 07:30 am.
Title
Salivary cortisol levels at home
Description
the treatment day
Time Frame
30th minute after awakening, between 07:00 and 07:30 am.
Title
Salivary cortisol levels at home
Description
the day after treatment
Time Frame
30th minute after awakening, between 07:00 and 07:30 am.
Title
Salivary cortisol levels at clinic
Description
the treatment day
Time Frame
beginning of the treatment, between 09:00 and 11:00 am.
Title
Salivary cortisol levels in clinic
Description
the treatment day
Time Frame
15th minute of the treatment, between 09:00 and 11:00 am.
Title
Salivary cortisol levels in clinic
Description
the treatment day
Time Frame
15th minute post treatment, between 09:00 and 11:00 am.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burçin Acar, Dr
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gulsum Duruk, Dr
Organizational Affiliation
Inonu University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sedat Yildiz, Prof.
Organizational Affiliation
Inonu University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cihat Uçar, Dr
Organizational Affiliation
Adiyaman University Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University
City
Malatya
ZIP/Postal Code
44280
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24766350
Citation
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.
Results Reference
result

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Dental Anxiety in Children and Salivary Cortisol Levels

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