Back to resultsEvaluation of Dental Anxiety in Second-Stage Implant Surgery With Er,Cr:YSGG Laser
Primary Purpose
Dental Anxiety
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Scalpel
2780 nm Er,Cr:YSGG Laser
Sponsored by
About this trial
This is an interventional treatment trial for Dental Anxiety focused on measuring Dental Anxiety, STAI, Er,Cr:YSGG, oral surgery
Eligibility 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,
Sites / Locations
- Van Yuzuncu Yil University Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Scalpel
Erbium laser
Arm Description
Soft tissue incision with scalpel in second- stage implant surgery.
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.
Outcomes
Primary Outcome Measures
Dental anxiety
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.
Dental Anxiety
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03871101
Brief Title
Evaluation of Dental Anxiety in Second-Stage Implant Surgery With Er,Cr:YSGG Laser
Official Title
Evaluation of Dental Anxiety in Patients Undergoing Second Stage Surgery With Er,Cr:YSGG Laser Treatment: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
September 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
Keywords
Dental Anxiety, STAI, Er,Cr:YSGG, oral surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scalpel
Arm Type
Active Comparator
Arm Description
Soft tissue incision with scalpel in second- stage implant surgery.
Arm Title
Erbium laser
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Scalpel
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
2780 nm Er,Cr:YSGG Laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dental anxiety
Description
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.
Time Frame
20 minutes before the operation
Title
Dental Anxiety
Description
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.
Time Frame
20 minutes before the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet C Talmac
Organizational Affiliation
Van Yuzuncu Yil University
Official's Role
Study Chair
Facility Information:
Facility Name
Van Yuzuncu Yil University Faculty of Dentistry
City
Van
ZIP/Postal Code
65080
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25572978
Citation
Candido MC, Andreatini R, Zielak JC, de Souza JF, Losso EM. Assessment of anxiety in patients who undergo surgical procedures for tooth implants: a prospective study. Oral Maxillofac Surg. 2015 Sep;19(3):253-8. doi: 10.1007/s10006-014-0480-3. Epub 2015 Jan 10.
Results Reference
background
PubMed Identifier
27918733
Citation
Kazancioglu HO, Dahhan AS, Acar AH. How could multimedia information about dental implant surgery effects patients' anxiety level? Med Oral Patol Oral Cir Bucal. 2017 Jan 1;22(1):e102-e107. doi: 10.4317/medoral.21254.
Results Reference
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Learn more about this trial
Evaluation of Dental Anxiety in Second-Stage Implant Surgery With Er,Cr:YSGG Laser
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