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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03819244
Other study ID # 24112017-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 27, 2017
Est. completion date August 20, 2018

Study information

Verified date January 2019
Source Yuzuncu Yil University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 20, 2018
Est. primary completion date May 24, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

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.
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 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)

Arnabat-Domínguez J, España-Tost AJ, Berini-Aytés 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. — View 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. — View Citation

Outcome

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