NCT06990919

Brief Summary

The stress levels of the participating child and their parents were evaluated using saliva to measure the stress biomarkers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 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

January 6, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2.9 years

First QC Date

May 18, 2025

Last Update Submit

May 24, 2025

Conditions

Stress BiomarkersAnxiety

Keywords

Alpha-amylaseCortisolDental anxietygeneral anesthesiadental treatments

Outcome Measures

Primary Outcomes (2)

  • alpha-amylase

    salivary biomarker

    1-month

  • cortisol

    salivary biomarker

    1-month

Study Arms (1)

Enrolled children

OTHER

All of the enrolled children have been followed for 1-month. Pre-operative and post-operative saliva samples have been collected from all participating children.

Other: Saliva collection

Interventions

Saliva collectionOTHER

Pre-operative saliva collected before the full mouth treatment under general anesthesia while, post-operative saliva collected at 1-month follow-up after general anesthesia.

Enrolled children

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • who did not allow their dental treatments to be completed using behavioral guidance techniques in the clinical environment.

You may not qualify if:

  • who were unable to give a saliva sample due to increased anxiety or inadequate saliva.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başkent University

Ankara, Cankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

May 18, 2025

First Posted

May 25, 2025

Study Start

January 6, 2021

Primary Completion

December 1, 2023

Study Completion

September 1, 2024

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

The data presented in this study are available from the corresponding authors upon reasonable request.

Locations

TU(1)