Condition category
Oral Health
Date applied
25/03/2020
Date assigned
26/03/2020
Last edited
26/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Gum disease is a very common condition where the gums become swollen, sore or infected.
Typical treatment for periodontal disease is scaling and root planing (SRP). This is a nonsurgical method that includes cleaning the surfaces of teeth and their roots, which may be exposed due to gum recession.
Laser treatment is a tissue-preserving, regenerative, and bone-building procedure. In general dentistry, the dentist uses a laser to access an infected pocket to kill the infected tissue and bacteria. Once the infected tissue is removed and the root is exposed, the calculus is removed with an ultrasonic root cleaner instead of scraping with hand tools. Lastly, laser energy is used to warm the stem cell that contains blood in the pocket, which creates a seal of tissues against the tooth root. Laser treatment ensures that no tissue is subtracted or gum tissue is reduced to a lower level on purpose. It also stimulates stem cells in the tissues to form new connective tissues, bone, and collagen. The body’s healing process then regenerates the lost ligaments and bone around the tooth.
The aim of the study was the combined application of Er:YAG and Nd:YAG laser irradiation to improve periodontal probing depths.

Who can participate?
Patients with severe periodontal (gum) disease.

What does the study involve?
The study involves a baseline examination, a laser treatment session and a reassessment after two months.

What are the possible benefits and risks of participating?
A possible benefit might be an improved periodontal condition. With the applied laser settings no side effects are expected.

Where is the study run from?
Medical University of Vienna (Austria)

When is the study starting and how long is it expected to run for?
January 2018 to January 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Markus Laky
markus.laky@meduniwien.ac.at

Trial website

Contact information

Type

Scientific

Primary contact

Dr Markus Laky

ORCID ID

http://orcid.org/0000-0001-7801-0995

Contact details

Sensengasse 2a
Vienna
1090
Austria
+43 1 40070 2346
markus.laky@meduniwien.ac.at

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

MUW-LP-15

Study information

Scientific title

Neodymium-doped yttrium aluminum garnet (Nd:YAG) laser and erbium-doped yttrium aluminum garnet (Er:YAG) laser in the treatment of periodontal disease

Acronym

Study hypothesis

Er:YAG and Nd:YAG laser application as an adjunct to conventional periodontal treatment might result in healthier periodontal conditions

Ethics approval

Approved 10/11/2017, Ethics committee of the Medical University of Vienna (Borschkegasse 8b/6, 1090 Vienna, Austria; +43 1 40400 21470; ethik-kom@meduniwien.ac.at), ref: 1747/2017

Study design

Single-blind randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Periodontal disease

Intervention

The periodontal patients in the test group had a laser intervention. Laser setting for the Nd:YAG laser was 2.5 W with an initiated fiber without water-cooling. Then a 60 seconds irradiation of the Er:YAG laser LightWalker was applied. The laser settings were 40 mJ, 40 Hz. Finally, 30 seconds stabilization of the forming blood clot was accomplished with a Nd:YAG laser 3.5 W.

In the control group all the steps were performed without activating the laser device.

Re-assessment was done eight weeks post-treatment.

A 1:1 randomization was performed. Before the start of the trial a 1:1 randomization list was prepared by flipping of a coin. After inclusion of the patient the allocation of the patient according to the randomization list was revealed to the treating clinican.

Intervention type

Device

Phase

Phase IV

Drug names

Er:YAG and Nd:YAG laser

Primary outcome measure

Periodontal probing depth (mm) measured using dental probe at baseline and two months after the intervention

Secondary outcome measures

Clinical attachment level measured using a periodontal probe (periodontal probing depth + clinical recession) at baseline and two months after the intervention
Bleeding on probing measured using dental probe at baseline and two months after the intervention

Overall trial start date

26/01/2015

Overall trial end date

21/01/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Adults with least one site with a probing depth of ≥ 6 mm around eight weeks post-completion of initial supra- and subgingival periodontal debridement

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

22

Total final enrolment

22

Participant exclusion criteria

Systemic diseases which could potentially influence outcome of the therapy (e.g. diabetes mellitus, pregnancy, immunosuppression, malignant diseases)

Recruitment start date

08/01/2018

Recruitment end date

08/01/2019

Locations

Countries of recruitment

Austria

Trial participating centre

Medical University of Vienna
Spitalgasse 23
Vienna
1090
Austria

Sponsor information

Organisation

Medical University of Vienna

Sponsor details

University Clinic of Dentistry
Spitalgasse 23
Vienna
1090
Austria
+43 1 40070 2101
office-unizahnklinik@meduniwien.ac.at

Sponsor type

University/education

Website

http://www.meduniwien.ac.at/homepage/1/homepage/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

30/06/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

26/03/2020: Trial’s existence confirmed by Ethics committee of the Medical University of Vienna.