The Effect of Mindfulness Meditation During Dental Implant Surgery

NCT05748223 | Completed

• 1 other identifier: Cukurova U
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Mindfulness; Dental Implant

Outcome Measures

Primary Outcomes (1)

• Change of Bispectral Index (BIS) monitoring

  The level of sedation achieved by meditation was assessed with BIS device. BIS values range between 100 and 0 and give the clinicians objective information about the depth of sedation.

  Change from baseline to 5th, 10th, 15th, 20th, 25th and 30th minutes

Secondary Outcomes (4)

• Cortisol

  At the baseline, immediately before and 5-minutes after surgery for both groups.

• Blood pressure

  Every 5-minutes starting from baseline until the end of surgery for both groups

• arterial blood oxygen saturation

  Every 5-minutes starting from baseline until the end of surgery for both groups

• heart rate value

  Every 5-minutes starting from baseline until the end of surgery for both groups

Study Arms (2)

Mindfulness Group

EXPERIMENTAL

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

Other: Mindfulness Meditation

Conventional Group

NO INTERVENTION

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

Interventions

Mindfulness Meditation 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

Mindfulness Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Faculty of Dentistry

Adana, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Onur Ucak Turer, Professor

  Professor in Periodontology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 28, 2023
• Study Start: May 20, 2022
• Primary Completion: November 11, 2022
• Study Completion: January 13, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)