NCT04338854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

February 10, 2020

Last Update Submit

April 6, 2020

Conditions

Dental Anxiety

Keywords

dental anxietycortisolprocedure

Outcome Measures

Primary Outcomes (6)

  • Salivary cortisol levels at home

    the day before treatment

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

  • Salivary cortisol levels at home

    the treatment day

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

  • Salivary cortisol levels at home

    the day after treatment

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

  • Salivary cortisol levels at clinic

    the treatment day

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

  • Salivary cortisol levels in clinic

    the treatment day

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

  • Salivary cortisol levels in clinic

    the treatment day

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

Study Arms (9)

Root canal treatment

EXPERIMENTAL

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.

Procedure: Restorative Treatment

Pulpotomy treatment

EXPERIMENTAL

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

Procedure: Restorative Treatment

two-surface restoration with Local Anesthesia

EXPERIMENTAL

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.

Procedure: Restorative Treatment

one surface restoration with Local Anesthesia

EXPERIMENTAL

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

Procedure: Restorative Treatment

two-surface restoration without Local Anesthesia

EXPERIMENTAL

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.

Procedure: Restorative Treatment

one surface restoration without Local Anesthesia

EXPERIMENTAL

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

Procedure: Restorative Treatment

fluoride application by disposable arch tray

EXPERIMENTAL

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.

Procedure: Restorative Treatment

fluoride application by cotton roll

EXPERIMENTAL

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.

Procedure: Restorative Treatment

Fissure Sealant group

EXPERIMENTAL

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

Procedure: Restorative Treatment

Interventions

Restorative TreatmentPROCEDURE

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.

Also known as: Protective Application
Fissure Sealant groupPulpotomy treatmentRoot canal treatmentfluoride application by cotton rollfluoride application by disposable arch trayone surface restoration with Local Anesthesiaone surface restoration without Local Anesthesiatwo-surface restoration with Local Anesthesiatwo-surface restoration without Local Anesthesia

Eligibility Criteria

Age7 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with Farnkl-1 and -2 classes had negative compliance to treatment and therefore they were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 24766350RESULT

MeSH Terms

Interventions

Dental Atraumatic Restorative Treatment

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Burçin Acar, Dr

    Inonu University

    PRINCIPAL INVESTIGATOR

  • Gulsum Duruk, Dr

    Inonu University

    STUDY DIRECTOR

  • Sedat Yildiz, Prof.

    Inonu University

    STUDY CHAIR

  • Cihat Uçar, Dr

    Adiyaman University Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2020

First Posted

April 8, 2020

Study Start

December 15, 2017

Primary Completion

April 20, 2018

Study Completion

July 25, 2018

Last Updated

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)