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
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