Treatment of periodontal disease with additional low-level laser therapy
| ISRCTN | ISRCTN11275257 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11275257 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Medical University of Vienna |
| Funder | Medizinische Universität Wien |
- Submission date
- 25/08/2023
- Registration date
- 16/10/2023
- Last edited
- 28/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Chronic periodontitis is a disease which attacks the tissues surrounding the teeth and affects almost every second adult. As the disease proceeds, the bones and teeth can be damaged, which can lead to tooth loss. Any periodontal pockets that have formed require
deep cleaning which can be combined with other treatment options in able to improve the therapy outcome. The aim of this study is to investigate a low-level laser as a complementary treatment to conventional periodontal treatment.
Who can participate?
Adults aged 25-55 with periodontal disease
What does the study involve?
All participants will receive the same treatment - standard periodontal treatment (deep cleaning) on both sides of the mouth. Each participant will have one side of their mouth randomly allocated to receive laser therapy.
What are the possible benefits and risks of participating?
The possible benefit of participating is that the laser may improve the success of regular gum treatment.
Where is the study run from?
University Clinic of Dentistry, Medical University of Vienna (Austria)
When is the study starting and how long is it expected to run for?
October 2016 to July 2023
Who is funding the study?
Medical University of Vienna (Austria)
Who is the main contact?
1. Prof. Rausch-Fan, xiaohui.rausch-fan@meduniwien.ac.at
2. Dr Selma Dervisbegovic, selma.dervisbegovic@meduniwien.ac.at
Contact information
Scientific
Sensengasse 2A
Vienna
1090
Austria
 ORCID ID |
0000-0003-3325-013X |
|---|---|
| Phone | +43 (0)1400704720 |
| selma.dervisbegovic@meduniwien.ac.at |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional double-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Adjunctive low‐level laser therapy in periodontal treatment – a randomized clinical split-mouth trial |
| Study acronym | LLLT |
| Study objectives | Adjunctive therapy with low‐level laser therapy (LLLT) results in better clinical parameters, compared to debridement only. |
| Ethics approval(s) |
Approved 14/06/2017, Ethics Committee Medical University of Vienna (Ethikommission Medizinische Universität Wien) (Borschkegasse 8b/E06, Vienna, 1090, Austria; +43 (0)1 40400 21470; ethik-kom@meduniwien.ac.at), ref: EK Nr.: 2241/2016 |
| Health condition(s) or problem(s) studied | Moderate to severe periodontitis |
| Intervention | Participants were randomised into a split-mouth design, with the allocation of the side to be treated (left or right) performed by drawing lots before the initial periodontal examination. Clinical and microbiological parameters were obtained in the initial examination. All of the sites received non-surgical therapy. Subsequently, one side of each study participant’s upper and lower jaws was treated with LLLT. The contralateral side remained untreated and served as a control. LLLT was carried out at sites with pockets in non contact mode and protective eyewear was provided to all participants. Clinical and microbiological parameters were repeated 12 weeks after initial treatment. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Denlase Diode Laser |
| Primary outcome measure(s) |
Bleeding on probing, assessed during probing with a calibrated standard probe at baseline and 12 weeks after the last treatment (re-evaluation) |
| Key secondary outcome measure(s) |
1. Oral hygiene, assessed using the Approximal-Plaque-Index (API) and the Papillary Bleeding Index (PBI) at the initial examination (baseline) and 12 weeks after the last treatment (re-evaluation) |
| Completion date | 01/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Moderate to severe periodontitis with a Periodontal Screening Index of 3 or 4; in regards to new classification: localized or generalized periodontitis of periodontal stage II, III or IV with grades B or C 2. Age 25-55 years 3. Presence of at least one site in each quadrant with probing depths above ≥5 mm with bleeding on probing 4. Radiologically-detectable alveolar bone loss in all quadrants 5. Good general health |
| Key exclusion criteria | 1. Pregnancy 2. Intake of antibiotics in the last 6 months 3. Periodontal treatment during the last 6 months 4. Infectious disease, chronic pulmonary disease, immunosuppressive medication or immunodeficiency, cancer, diabetes, other apparent oral infection |
| Date of first enrolment | 01/07/2017 |
| Date of final enrolment | 20/08/2022 |
Locations
Countries of recruitment
- Austria
Study participating centre
Vienna
1090
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/04/2025 | 28/04/2025 | Yes | No |
Editorial Notes
28/04/2025: Publication reference added.
07/09/2023: Study's existence confirmed by the Ethics Committee Medical University of Vienna (Austria).
