NCT03819244

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2017

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

November 27, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

January 16, 2019

Last Update Submit

January 25, 2019

Conditions

Postoperative PainSoft Tissue BleedingWound Heal

Keywords

Diode LaserErbium LaserSecond-stage Implant Surgery

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Number of analgesics used daily

    3 days

  • Intraoperative bleeding

    During operation

Study Arms (2)

Diode laser

EXPERIMENTAL

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

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

940 nm Gallium Aluminum Arsenide Diode LaserDEVICE

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.

Diode laser
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

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University Faculty of Dentistry

Van, 65080, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 24210453BACKGROUND

  • 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.

    PMID: 12608675BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Erkan Feslihan, DDS

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

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

January 16, 2019

First Posted

January 28, 2019

Study Start

November 27, 2017

Primary Completion

May 24, 2018

Study Completion

August 20, 2018

Last Updated

January 29, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available within 6 months.
Access Criteria
Open access

Locations

TU(1)