Dental Anxiety During Restorative Dental Treatment

NCT ID: NCT06629870

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-26

Study Completion Date

2024-05-29

Brief Summary

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Anxiety refers to behavioural disorders associated with excessive fear and anxiety. Dental anxiety refers to excessive fear and anxiety at the thought of going to the dentist. This may cause patients to avoid dental treatments and may adversely affect oral health.

This study aims to evaluate the effects of hypnotherapy, virtual reality distraction and mindfulness-based meditation practices on dental anxiety during restorative dental treatment.

Detailed Description

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Conditions

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Hypnotherapy Virtual Reality Mindfulness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

control group

Intervention Type OTHER

no any anxiety-reducing application

hypnotherapy

Group Type ACTIVE_COMPARATOR

hypnotherapy

Intervention Type OTHER

patients receiving hypnotherapy

virtual reality

Group Type ACTIVE_COMPARATOR

virtual reality

Intervention Type DEVICE

patients who received distraction using virtual reality glasses

mindfulness-based meditation

Group Type ACTIVE_COMPARATOR

mindfulness

Intervention Type OTHER

patients who underwent mindfulness-based meditation

Interventions

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virtual reality

patients who received distraction using virtual reality glasses

Intervention Type DEVICE

control group

no any anxiety-reducing application

Intervention Type OTHER

hypnotherapy

patients receiving hypnotherapy

Intervention Type OTHER

mindfulness

patients who underwent mindfulness-based meditation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A modified dental anxiety score of 20 and above
* A dental fear scale score of 59 and above
* D2 level caries according to radiographic caries classification system,
* Systemically healthy patients

Exclusion Criteria

* Balance disorders such as nystagmus and vertigo,
* Pregnant woman
* Claustrophobia
* Physical or mental disability
* Not knowing how to read and write
* Psychological disturbance
* Taking antidepressants or anxiolytics
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Fatih Alkan

Research assistant dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ataturk University Faculty of Dentistry

Erzurum, Yakutiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Joda T, Gallucci GO, Wismeijer D, Zitzmann NU. Augmented and virtual reality in dental medicine: A systematic review. Comput Biol Med. 2019 May;108:93-100. doi: 10.1016/j.compbiomed.2019.03.012. Epub 2019 Mar 15.

Reference Type RESULT
PMID: 31003184 (View on PubMed)

Prado IM, Carcavalli L, Abreu LG, Serra-Negra JM, Paiva SM, Martins CC. Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2019 Sep;29(5):650-668. doi: 10.1111/ipd.12499. Epub 2019 Apr 25.

Reference Type RESULT
PMID: 30908775 (View on PubMed)

Other Identifiers

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ATAUNIRESTORATIVE1

Identifier Type: -

Identifier Source: org_study_id

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