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Evaluation of Dental Anxiety in Second-Stage Implant Surgery With Er,Cr:YSGG Laser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03871101
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Erkan Feslihan, Yuzuncu Yıl University

Study Description
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Brief Summary:
Implants embedded under the oral mucosa were exposed with scalpel (Group 1) or laser surgery (Group 2). Before the operation the patients were asked to fill the State-Trait Anxiety Inventory (STAI) and Dental Anxiety Scale (DAS) while resting in the waiting room.

Condition or disease Intervention/treatment Phase
Dental Anxiety Procedure: Scalpel Device: 2780 nm Er,Cr:YSGG Laser Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Dental Anxiety in Patients Undergoing Second Stage Surgery With Er,Cr:YSGG Laser Treatment: Randomized Clinical Trial
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : September 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Scalpel
Soft tissue incision with scalpel in second- stage implant surgery.
 Procedure: Scalpel
Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with scalpel for placing the healing abutment.
Experimental: Erbium laser
Soft tissue incision with 2780 nm Er,Cr:YSGG laser, at implant recovery settings (2.00 W power, 100 Hz H mode, 10% water and 10% air) in second-stage implant surgery.
 Device: 2780 nm Er,Cr:YSGG Laser
Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with erbium laser for placing the healing abutment.


Outcome Measures
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Primary Outcome Measures :
  1. Dental anxiety [ Time Frame: 20 minutes before the operation ]
    Before the operation the patients were asked to fill the State-Trait Anxiety Inventory (STAI) questionary.Patients' answers to each question were scored between 1-4 points. A total of 20-37 anxiety scores were assessed as minimum level of anxiety or none, 38-44 points as moderate and 45-80 as high.

  2. Dental Anxiety [ Time Frame: 20 minutes before the operation ]
    Before the operation the patients were asked to fill the Dental Anxiety Scale (DAS). Patients' answers to questions were scored between 1-4 points. The total score of the questions in the questionnaire ranged from 4 to 20, and 4-11 points were interpreted as low level dental anxiety, 12-14 points as moderate and more than 14 points as high.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients undergoing second-stage implant surgery

Exclusion Criteria:

  • Patients without sufficient keratinized gingiva
  • Bone overlap on closure screw
  • Implants that can not be localized due to gingiva thickness,
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871101


Locations
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Turkey
Van Yuzuncu Yil University Faculty of Dentistry
Van, Turkey, 65080
Sponsors and Collaborators
Yuzuncu Yıl University
Investigators
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Study Chair: Ahmet C Talmac Van Yuzuncu Yil University
  Study Documents (Full-Text)

Documents provided by Erkan Feslihan, Yuzuncu Yıl University:
Study Protocol and Statistical Analysis Plan  [PDF] November 24, 2017

More Information
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Publications:

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Responsible Party: Erkan Feslihan, Principal investigator, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03871101    
Other Study ID Numbers: 24112017-02
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Erkan Feslihan, Yuzuncu Yıl University:
Dental Anxiety
STAI
Er,Cr:YSGG
oral surgery
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders