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

Dental Anxiety Clinical Trial

Official title:

Evaluation of Dental Anxiety in Patients Undergoing Second Stage Surgery With Er,Cr:YSGG Laser Treatment: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871101
• Other study ID #: 24112017-02
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: September 17, 2018

Study information

• Verified date: March 2019
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 17, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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,

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

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.

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.

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University Faculty of Dentistry	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 minutes before the operation
Primary	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.	20 minutes before the operation