Socket Preservation With Er:YAG and Nd:YAG Lasers

March 8, 2022 updated by: Krizaj d.o.o.

Post-extraction Treatment With Er:YAG and Nd:YAG Lasers - Socket Preservation

Alveolar bone regeneration after laser-assisted extraction will be compared with bone regeneration after standard extraction procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

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

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Klinika Križaj

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient requires at least one simple extraction
  • Voluntary informed consent to participate in the study

Exclusion Criteria:

  • Pregnancy
  • Use of photosensitizing medication
  • Refuse participation
  • Require complicated extraction

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser
After extraction, Er:YAG and Nd:YAG lasers used for degranulation, disinfection, deepithelialization, clot stabilization and photobiomodulation.
Device: Er:YAG and Nd:YAG lasers
Extraction followed by Er:YAG laser degranulation, Nd:YAG laser disinfection, Er:YAG deepithelialization, Nd:YAG blood clot stabilization and photobiomodulation. The photobiomodulation step repeated on day 3, 5, and 7.
Other Names:
  • Fotona
  • Twinlight
  • laser alveolar preservation
  • LightWalker
Active Comparator: Control
Standard extraction procedure.
Procedure: Standard extraction
Standard extraction procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone density from immediate post-extraction
Time Frame: 3 months
Cone Beam Computed Tomography (CBCT)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density
Time Frame: 3 months
Cone Beam Computed Tomography (CBCT)
3 months
Bone thickness
Time Frame: 3 months
Cone Beam Computed Tomography (CBCT)
3 months
Treatment pain
Time Frame: day 1
On a pain scale from 0 (no pain) to 10 (intolerable pain)
day 1
Treatment pain
Time Frame: day 3
On a pain scale from 0 (no pain) to 10 (intolerable pain)
day 3
Treatment pain
Time Frame: day 5
On a pain scale from 0 (no pain) to 10 (intolerable pain)
day 5
Treatment pain
Time Frame: day 7
On a pain scale from 0 (no pain) to 10 (intolerable pain)
day 7

Collaborators and Investigators

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

Sponsor

Krizaj d.o.o.

Investigators

  • Principal Investigator: Aleksandra Križaj Dumić, MDD, Krizaj d.o.o.

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)

August 20, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • socket preservation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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