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CompletedNCT05748223Updated Feb 28, 2023

The Effect of Mindfulness Meditation During Dental Implant Surgery

An interventional study of Mindfulness Meditation in Mindfulness and Dental Implant, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-28.

Sponsored by Cukurova University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled May 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mindfulness
  • Dental Implant
03

In context

Lead sponsor

Cukurova University is the lead sponsor of 247 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Mindfulness Group

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

    Other: Mindfulness Meditation

  • No intervention
    Conventional Group

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

Interventions

  • OtherMindfulness 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

06

What researchers measure

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.

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

Secondary outcomes

  1. Cortisol

    The cortisol levels were biochemically evaluated

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

  2. Blood pressure

    systolic and diastolic blood pressure (in mmHg) via vital signs monitor for both groups

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

  3. arterial blood oxygen saturation

    in 'percentage %' via vital signs monitor for both groups

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

  4. heart rate value

    in 'beats per minute' via vital signs monitor for both groups

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

07

Study locations

1 site
  • Cukurova University Faculty of Dentistry
    Adana, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05748223
Lead sponsor
Cukurova University
Responsible party
Cenk Haytac (Profesor, Cukurova University) — Principal investigator
First posted
Feb 28, 2023
Start date
May 20, 2022
Primary completion
Nov 11, 2022
Completion
Jan 13, 2023
Last update
Feb 28, 2023

Study contacts

Onur Ucak Turer, Professor
principal investigator · Professor in Periodontology Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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