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

Primary Purpose

Postoperative Pain, Soft Tissue Bleeding, Wound Heal

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

940 nm Gallium Aluminum Arsenide Diode Laser

2780 nm Er,Cr:YSGG Laser

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Diode Laser, Erbium Laser, Second-stage Implant Surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Yuzuncu Yil University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Diode laser

Erbium laser

Arm Description

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.

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

Postoperative pain on 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.

Postoperative pain on 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.

Postoperative pain on 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.

Secondary Outcome Measures

Number of analgesics used daily

Analgesic consumption per day on postoperative 1st, 2nd and 3rd days.

Intraoperative bleeding

Bleeding during surgical procedure was scored by the physician as 1=minimal, 2=normal and 3=excessive bleeding

Full Information

NCT ID

NCT03819244

First Posted

January 16, 2019

Last Updated

January 25, 2019

Sponsor

Yuzuncu Yıl University

1. Study Identification

Unique Protocol Identification Number

NCT03819244

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

November 27, 2017 (Actual)

Primary Completion Date

May 24, 2018 (Actual)

Study Completion Date

August 20, 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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Soft Tissue Bleeding, Wound Heal

Keywords

Diode Laser, Erbium Laser, Second-stage Implant Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diode laser

Arm Type

Experimental

Arm Description

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

Device

Intervention Name(s)

940 nm Gallium Aluminum Arsenide Diode Laser

Intervention Description

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.

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

Postoperative pain on 1st day

Description

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.

Time Frame

1st Day

Title

Postoperative pain on 2nd day

Description

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.

Time Frame

2nd Day

Title

Postoperative pain on 3rd day

Description

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.

Time Frame

3rd Day

Secondary Outcome Measure Information:

Title

Number of analgesics used daily

Description

Analgesic consumption per day on postoperative 1st, 2nd and 3rd days.

Time Frame

3 days

Title

Intraoperative bleeding

Description

Bleeding during surgical procedure was scored by the physician as 1=minimal, 2=normal and 3=excessive bleeding

Time Frame

During operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erkan Feslihan, DDS

Organizational Affiliation

Van Yuzuncu Yil University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yuzuncu Yil University Faculty of Dentistry

City

Van

ZIP/Postal Code

65080

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

24210453

Citation

El-Kholey KE. Efficacy and safety of a diode laser in second-stage implant surgery: a comparative study. Int J Oral Maxillofac Surg. 2014 May;43(5):633-8. doi: 10.1016/j.ijom.2013.10.003. Epub 2013 Nov 7.

Results Reference

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PubMed Identifier

12608675

Citation

Arnabat-Dominguez J, Espana-Tost AJ, Berini-Aytes L, Gay-Escoda C. Erbium:YAG laser application in the second phase of implant surgery: a pilot study in 20 patients. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):104-12.

Results Reference

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Learn more about this trial

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

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