NCT03871101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 9, 2019

Last Update Submit

March 11, 2019

Conditions

Dental Anxiety

Keywords

Dental AnxietySTAIEr,Cr:YSGGoral surgery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Scalpel

ACTIVE COMPARATOR

Soft tissue incision with scalpel in second- stage implant surgery.

Procedure: Scalpel

Erbium laser

EXPERIMENTAL

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

Interventions

ScalpelPROCEDURE

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.

Scalpel
2780 nm Er,Cr:YSGG LaserDEVICE

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.

Erbium laser

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing second-stage implant surgery

You may not qualify if:

  • Patients without sufficient keratinized gingiva
  • Bone overlap on closure screw
  • Implants that can not be localized due to gingiva thickness,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University Faculty of Dentistry

Van, 65080, Turkey (Türkiye)

Location

Related 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.

    PMID: 25572978BACKGROUND

  • 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.

    PMID: 27918733BACKGROUND

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Ahmet C Talmac

    Yuzuncu Yil University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 9, 2019

First Posted

March 12, 2019

Study Start

January 8, 2018

Primary Completion

July 10, 2018

Study Completion

September 17, 2018

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)