The use of lasers in the treatment of gum disease
| ISRCTN | ISRCTN32132076 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32132076 |
| Secondary identifying numbers | MUW-LP-15 |
- Submission date
- 25/03/2020
- Registration date
- 26/03/2020
- Last edited
- 06/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Sensengasse 2a
Vienna
1090
Austria
 ORCID ID |
0000-0001-7801-0995 |
|---|---|
| Phone | +43 1 40070 2346 |
| markus.laky@meduniwien.ac.at |
Study information
| Study design | Single-blind randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Er:YAG and Nd:YAG laser application as an adjunct to conventional periodontal treatment might result in healthier periodontal conditions |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 26/01/2015 |
| Completion date | 21/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 22 |
| Total final enrolment | 22 |
| Key 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 |
| Key exclusion criteria | Systemic diseases which could potentially influence outcome of the therapy (e.g. diabetes mellitus, pregnancy, immunosuppression, malignant diseases) |
| Date of first enrolment | 08/01/2018 |
| Date of final enrolment | 08/01/2019 |
Locations
Countries of recruitment
- Austria
Study participating centre
Vienna
1090
Austria
Sponsor information
University/education
University Clinic of Dentistry
Spitalgasse 23
Vienna
1090
Austria
| Phone | +43 1 40070 2101 |
|---|---|
| office-unizahnklinik@meduniwien.ac.at | |
| Website | http://www.meduniwien.ac.at/homepage/1/homepage/ |
"ROR" |
https://ror.org/05n3x4p02 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/04/2021 | Yes | No |
Editorial Notes
06/04/2021: Publication reference added.
26/03/2020: Trial’s existence confirmed by Ethics committee of the Medical University of Vienna.
