Socket Preservation With Er:YAG and Nd:YAG Lasers

Post-extraction Bone Regeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232202
• Other study ID #: Socket preservation
• Status: Completed
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: March 2022
• Source: Krizaj d.o.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-extraction Bone Regeneration

Intervention

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.

Procedure:
• Standard extraction
Standard extraction procedure

Locations

Country	Name	City	State
Slovenia	Klinika Križaj	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Krizaj d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone density from immediate post-extraction	Cone Beam Computed Tomography (CBCT)	3 months
Secondary	Bone density	Cone Beam Computed Tomography (CBCT)	3 months
Secondary	Bone thickness	Cone Beam Computed Tomography (CBCT)	3 months
Secondary	Treatment pain	On a pain scale from 0 (no pain) to 10 (intolerable pain)	day 1
Secondary	Treatment pain	On a pain scale from 0 (no pain) to 10 (intolerable pain)	day 3
Secondary	Treatment pain	On a pain scale from 0 (no pain) to 10 (intolerable pain)	day 5
Secondary	Treatment pain	On a pain scale from 0 (no pain) to 10 (intolerable pain)	day 7