NCT07019688

Brief Summary

The aim of this clinical study is to investigate the effects of different information methods on patients' anxiety levels during dental procedures under anesthesia. Additionally, the study seeks to evaluate patients' concerns and willingness regarding dental treatment under anesthesia, as well as their awareness of the associated risks. The main questions this study aims to answer are:

  • How do various information methods influence patients' anxiety levels related to dental procedures under anesthesia?
  • What is the relationship between patients' anxiety levels and their awareness of risks associated with dental treatment under anesthesia? The study hypothesizes that different information methods may vary in their effectiveness at reducing patient stress, and that patients' anxiety levels regarding dental treatment under anesthesia may be associated with their knowledge about potential risks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

June 5, 2025

Last Update Submit

March 15, 2026

Conditions

Keywords

Dental anxietyImpacted molar extractionPatient educationHealth communicationArtificial intelligenceAnesthesia-related anxiety

Outcome Measures

Primary Outcomes (1)

  • Change in Dental Anxiety Level

    Change in anxiety levels measured using the Modified Dental Anxiety Scale (MDAS) before and one week after the informational intervention. The primary comparison will assess differences between the three groups receiving different information methods.

    Baseline (pre-information) and 1 week post-information

Study Arms (3)

Group 1: Standard Info

Participants receive the standard written information routinely provided before molar tooth extraction.

Other: Standard Information

Group 2: Clinician Info

Participants receive written information prepared by clinicians that includes answers to the most frequently asked questions from previous patients.

Other: Clinician Information

Group 3: AI Info

Participants receive written information generated by ChatGPT based on the identified frequently asked questions.

Other: AI Info

Interventions

Participants will receive only the standard written information routinely provided prior to dental procedures. This version does not include any additional content related to frequently asked questions.

Group 1: Standard Info

Participants will receive written information prepared by clinicians, which includes responses to the most frequently asked questions collected from patients undergoing same procedures.

Group 2: Clinician Info
AI InfoOTHER

Participants will receive written information generated by ChatGPT, based on the identified frequently asked questions and formulated specifically for this study.

Group 3: AI Info

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population consists of adult patients aged 18 to 40 years who are scheduled for the extraction of impacted mandibular molar teeth with a predicted moderate level of difficulty and no anticipated complications. Eligible participants must be systemically healthy, not taking any regular medications, and must have no prior history of sedation, general anesthesia, or surgical removal of impacted molars. Individuals who have previously received verbal, written, or visual information regarding impacted molar extraction will be excluded. Only patients who voluntarily consent to participate and are agreeing to receive preoperative information will be included.

You may qualify if:

  • Indication for moderately difficult, non-complicated impacted mandibular molar extraction
  • Aged 18-40 years
  • No systemic disease or regular medication use
  • No previous procedures under sedation or general anesthesia
  • No history of impacted molar surgery or complicated extractions
  • No prior verbal, written, or visual information on molar extractions

You may not qualify if:

  • Complex or multiple (\>2) molar extractions
  • Intellectual disability
  • Emergency cases
  • Refusal to participate or to receive preoperative information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University, Faculty of Dentistry

Kırıkkale, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 13, 2025

Study Start

June 16, 2025

Primary Completion

February 27, 2026

Study Completion

February 27, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The Individual Participant Data (IPD) will not be publicly available but can be shared upon reasonable request.

Locations