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The Effect of Mindfulness Meditation During Dental Implant Surgery

NCT ID: NCT05748223

Last Updated: 2023-02-28

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2023-01-13

Brief Summary

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The aim of this pioneer study was to evaluate the efficacy (heart rate value, blood pressure, oxygen saturation, cortisol levels, BIS monitoring, patients' anxiety) of Mindfulness Meditation as a sedative technique during dental implant surgery.

Detailed Description

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Since anxiety is a form of psychological stress, an increase in anxiety results in a surge in stress levels. The role of sedation in dental surgery cannot be overemphasised. The reduction in pain and anxiety eventually causes better cooperation and patients' satisfaction. Therefore, balancing anxiety and/or stress levels in patients would be useful to ensure patient safety during treatment.Therefore, the aim of this pioneer study was to evaluate the efficacy (heart rate value, blood pressure, oxygen saturation, cortisol levels, BIS monitoring, patients' anxiety) of Mindfulness Meditation as a sedative technique during dental implant surgery.

Conditions

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Mindfulness Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness Group

The patients in this group received mindfulness meditation before dental implant surgery.

Group Type EXPERIMENTAL

Mindfulness Meditation

Intervention Type OTHER

Mindfulness meditation has been reported to produce beneficial effects on a number of psychiatric, functional somatic, and stress-related symptoms and has therefore increasingly been incorporated into psychotherapeutic programs

Conventional Group

The patients in this group did not receive mindfulness meditation before dental implant surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness Meditation

Mindfulness meditation has been reported to produce beneficial effects on a number of psychiatric, functional somatic, and stress-related symptoms and has therefore increasingly been incorporated into psychotherapeutic programs

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age between 25-65 years-old
* single tooth loss in the maxillary premolar-molar region with partial bone healing (type 3) or fully healed ridge type 4
* sufficient bony ridge for implant placement without the need for simultaneous bone grafting or sinus lift procedure
* no signs of acute oral infection,
* more than 2 mm of keratinized gingiva at the site of surgery
* periodontally healthy (or successfully treated) and otherwise healthy or had well-controlled systemic disease (ASA classification I, II).

Exclusion Criteria

* diabetes mellitus
* smoking
* pregnancy;
* diagnosis of anxiety disorders/psychiatric disorder/ depression and whether or not they were seeking any form of treatment for these conditions;
* poor oral hygiene (plaque control record \> 30%);
* history of radiation therapy at head and neck area and chemotherapy; bony pathologies; history of soft tissue grafting at the prospective implant site
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Cenk Haytac

Profesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Onur Ucak Turer, Professor

Role: PRINCIPAL_INVESTIGATOR

Professor in Periodontology Department

Locations

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Cukurova University Faculty of Dentistry

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Cukurova U

Identifier Type: -

Identifier Source: org_study_id