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