Comparison of Er,Cr:YSGG and Diode Lasers In Second Stage Implant Surgery

January 25, 2019 updated by: Erkan Feslihan, Yuzuncu Yıl University

Clinical Comparison of The Use of Er,Cr:YSGG and Diode Lasers In Second Stage Implant Surgery

The study evaluates postoperative pain, intraoperative bleeding and wound healing after second stage implant surgery. Submerged implants were exposed with diode laser in Group 1 (n=20) and by using Er,Cr:YSGG laser in Group 2 (n=20).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey, 65080
        • Yuzuncu Yil University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subject has osseointegrated implants embedded under oral mucosa.
  • subject undergoes second-stage implant surgery.

Exclusion Criteria:

  • inadequate keratinized gingiva in the implant site.
  • localization of the implant site is not possible due to excessive thickness of the oral mucosa

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diode laser
Soft tissue incision with 940 nm Gallium Aluminum Arsenide diode laser, at implant recovery settings (2.5 W output power, average power: 1.25 W, pulse length : 1.00 ms, pulse interval: 1.00 ms) in second-stage implant surgery.
Device: 940 nm Gallium Aluminum Arsenide Diode Laser
Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with diode laser 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain on 1st day
Time Frame: 1st Day
Patients score pain intensity with numeric scale ranging between 0(no pain) to 10(most severe pain) on the postoperative 1st day. Pain scores on the postoperative 1st day in each group are compared.
1st Day
Postoperative pain on 2nd day
Time Frame: 2nd Day
Patients score pain intensity with numeric scale ranging between 0(no pain) to 10(most severe pain) on the postoperative 2nd day. Pain scores on the postoperative 2nd day in each group are compared.
2nd Day
Postoperative pain on 3rd day
Time Frame: 3rd Day
Patients score pain intensity with numeric scale ranging between 0(no pain) to 10(most severe pain) on the postoperative 3rd day. Pain scores on the postoperative 3rd day in each group are compared.
3rd Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of analgesics used daily
Time Frame: 3 days
Analgesic consumption per day on postoperative 1st, 2nd and 3rd days.
3 days
Intraoperative bleeding
Time Frame: During operation
Bleeding during surgical procedure was scored by the physician as 1=minimal, 2=normal and 3=excessive bleeding
During operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Investigators

  • Principal Investigator: Erkan Feslihan, DDS, Van Yuzuncu Yil University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2017

Primary Completion (Actual)

May 24, 2018

Study Completion (Actual)

August 20, 2018

Study Registration Dates

First Submitted

January 16, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24112017-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be shared after publication of the article about this study.

IPD Sharing Time Frame

Data will be available within 6 months.

IPD Sharing Access Criteria

Open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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