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Clinical Trials/NCT04932759
NCT04932759CompletedNot Applicable

Investigation Of The Effect Of Music Listened By Patients With Moderate Dental Anxiety During The Restoration Of Posterior Occlusal Dental Caries

Karadeniz Technical University2 sites in 1 country70 target enrollmentStarted: January 10, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
2
Primary Endpoint
Salivary cortisol level

Study Overview

Brief Summary

It is aimed to evaluate the effect of music listened by patients with moderate dental anxiety during the restoration of posterior occlusal dental caries on vital signs of the participants.

Detailed Description

The study will be applied on 70 patients; 35 patients will be in the control group (the group not listening to music during treatment), 35 patients will be in the experimental group (the group listening to music during treatment).

Modified Dental Anxiety Scale consisting of 5 questions will be applied to the participants who come to the clinic and have occlusal dental caries in the posterior region. The participants whose scores are between 10-18 according to this scale will be included in the study. One occlusal tooth decay will be treated. Before starting treatment, saliva cortisol levels, heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be made. The participants will be asked to spit in sterile plastic containers for saliva cortisol measurement. During dental treatment, the participants will listen to music in experimental group. In control group the participant will not listen to music. Heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be repeated in the middle of the treatment (without going through the restoration phase when the cavity is opened). Saliva cortisol levels, heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be repeated when the treatment is completed. The questionnaire containing the modified dental anxiety scale will be re-administered to the participants.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Must be healthy volunteers, Clinical diagnosis of at least one occlusal dental caries, Must have moderate dental anxiety

Exclusion Criteria

  • Unhealthy volunteers, Teeth with dental cavities in the adjacent teeth where the rubber dam would not be placed, and dental caries closer than 1 mm to the pulp tissue were not included in the study

Outcomes

Primary Outcomes

Salivary cortisol level

Time Frame: Before-after

Change of salivay cortisol level (before-after)

Vital anxiety signs

Time Frame: Before-after

Change of heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements

Secondary Outcomes

  • Modified dental anxiety questionnaire(Before-after)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kıvanc Dulger

Assistant Professor

Karadeniz Technical University

Study Sites (2)

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