Clinical trial NCT05748223: The Effect of Mindfulness Meditation During Dental Implant Surgery
Official title: The Effect of Mindfulness Meditation on Bispectral Index Monitoring, Physiological Findings and Cortisol Levels During Dental Implant Surgery: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Dental Implant
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 42
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: . The inclusion criteria were:

* 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 were

* 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

Primary outcomes:
measure: Change of Bispectral Index (BIS) monitoring
timeFrame: Change from baseline to 5th, 10th, 15th, 20th, 25th and 30th minutes
Secondary outcomes:
measure: Cortisol
timeFrame: At the baseline, immediately before and 5-minutes after surgery for both groups.
measure: Blood pressure
timeFrame: Every 5-minutes starting from baseline until the end of surgery for both groups
measure: arterial blood oxygen saturation
timeFrame: Every 5-minutes starting from baseline until the end of surgery for both groups
measure: heart rate value
timeFrame: Every 5-minutes starting from baseline until the end of surgery for both groups
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Dentistry
Study officials:
affiliation: Professor in Periodontology Department
name: Onur Ucak Turer, Professor
role: PRINCIPAL_INVESTIGATOR
References: