NCT04232202

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

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

August 20, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

January 14, 2020

Last Update Submit

March 8, 2022

Conditions

Post-extraction Bone Regeneration

Keywords

tooth extractionalveolar bonebone regenerationlaser

Outcome Measures

Primary Outcomes (1)

  • Change in bone density from immediate post-extraction

    Cone Beam Computed Tomography (CBCT)

    3 months

Secondary Outcomes (6)

  • Bone density

    3 months

  • Bone thickness

    3 months

  • Treatment pain

    day 1

  • Treatment pain

    day 3

  • Treatment pain

    day 5

  • +1 more secondary outcomes

Study Arms (2)

Laser

EXPERIMENTAL

After extraction, Er:YAG and Nd:YAG lasers used for degranulation, disinfection, deepithelialization, clot stabilization and photobiomodulation.

Device: Er:YAG and Nd:YAG lasers

Control

ACTIVE COMPARATOR

Standard extraction procedure.

Procedure: Standard extraction

Interventions

Er:YAG and Nd:YAG lasersDEVICE

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.

Also known as: Twinlight, laser alveolar preservation, LightWalker, Fotona
Laser
Standard extractionPROCEDURE

Standard extraction procedure

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinika Križaj

Ljubljana, 1000, Slovenia

Location

Study Officials

  • Aleksandra Križaj Dumić, MDD

    Krizaj d.o.o.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
CBCT will be used to assess bone density and the assessors will be unaware of the patient allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly assigned to either laser or control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

August 20, 2019

Primary Completion

March 31, 2020

Study Completion

July 31, 2020

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)