Post-extraction Bone RegenerationNCT04232202
Socket Preservation With Er:YAG and Nd:YAG Lasers
A study testing Er:YAG and Nd:YAG lasers and Standard extraction in people with Post-extraction Bone Regeneration, run by Krizaj d.o.o. at 1 site in Slovenia.
Trial summary
Alveolar bone regeneration after laser-assisted extraction will be compared with bone regeneration after standard extraction procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-extraction Bone Regeneration
- What is being tested?
- Er:YAG and Nd:YAG lasers and Standard extraction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Aug 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requires at least one simple extraction
- Voluntary informed consent to participate in the study
Who cannot join
- Pregnancy
- Use of photosensitizing medication
- Refuse participation
- Require complicated extraction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post-extraction Bone Regeneration
- Being tested
- Er:YAG and Nd:YAG lasers, Standard extraction
- Keywords
- tooth extraction, alveolar bone, bone regeneration, laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG and Nd:YAG lasersDevice
Also called Twinlight, laser alveolar preservation, LightWalker, Fotona
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.
Standard extractionProcedure or surgery
Standard extraction procedure
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | After extraction, Er:YAG and Nd:YAG lasers used for degranulation, disinfection, deepithelialization, clot stabilization and photobiomodulation. Receives: Device: Er:YAG and Nd:YAG lasers |
| Control | Active comparator | Standard extraction procedure. Receives: Procedure: Standard extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone density from immediate post-extraction
Cone Beam Computed Tomography (CBCT)
Measured: 3 months
Secondary outcomes (6)
Bone density
Cone Beam Computed Tomography (CBCT)
Measured: 3 months
Bone thickness
Cone Beam Computed Tomography (CBCT)
Measured: 3 months
Treatment pain
On a pain scale from 0 (no pain) to 10 (intolerable pain)
Measured: day 1
Treatment pain
On a pain scale from 0 (no pain) to 10 (intolerable pain)
Measured: day 3
Treatment pain
On a pain scale from 0 (no pain) to 10 (intolerable pain)
Measured: day 5
Treatment pain
On a pain scale from 0 (no pain) to 10 (intolerable pain)
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Aug 2019
- Primary completion31 Mar 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-extraction Bone RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to either laser or control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krizaj d.o.o.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksandra Križaj Dumić, MDD, Principal investigator, Krizaj d.o.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232202
- Sponsor's protocol ID
- Socket preservation
- Status last verified
- Mar 2022
- First submitted
- 14 Jan 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-extraction Treatment With Er:YAG and Nd:YAG Lasers - Socket Preservation
- ClinicalTrials.gov ID
- NCT04232202
- Acronym / sponsor ID
- Socket preservation
- Conditions
- Post-extraction Bone Regeneration
- Keywords
- tooth extraction, alveolar bone, bone regeneration, laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Krizaj d.o.o.University, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alveolar bone regeneration after laser-assisted extraction will be compared with bone regeneration after standard extraction procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to either laser or control group.
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Device: Er:YAG and Nd:YAG lasersAfter extraction, Er:YAG and Nd:YAG lasers used for degranulation, disinfection, deepithelialization, clot stabilization and photobiomodulation. |
| Control | Active comparator | Procedure: Standard extractionStandard extraction procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient requires at least one simple extraction
- Voluntary informed consent to participate in the study
Key exclusion criteria (4 listed)
- Pregnancy
- Use of photosensitizing medication
- Refuse participation
- Require complicated extraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Er:YAG and Nd:YAG lasersAlso: Twinlight, laser alveolar preservation, LightWalker, FotonaExtraction 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. | Device | Laser |
| Standard extractionStandard extraction procedure | Procedure or surgery | Control |
Primary outcome
Change in bone density from immediate post-extraction
Time frame: 3 months
Cone Beam Computed Tomography (CBCT)
6 secondary outcomes
Bone density
Time frame: 3 months
Bone thickness
Time frame: 3 months
Treatment pain
Time frame: day 1
Treatment pain
Time frame: day 3
Treatment pain
Time frame: day 5
Treatment pain
Time frame: day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Križaj Dumić, MDD principal investigator
Krizaj d.o.o.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Er:YAG and Nd:YAG lasers and Standard extraction in people with Post-extraction Bone Regeneration, run by Krizaj d.o.o. at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone density from immediate post-extraction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022; AzTrials last refreshed its copy on 2 Nov 2026.