The benefits of Nd:YAG laser in the treatment of gum disease in an adult population
| ISRCTN | ISRCTN26692900 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26692900 |
| Secondary identifying numbers | 252/31-07-2014 |
- Submission date
- 07/06/2022
- Registration date
- 09/06/2022
- Last edited
- 11/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Periodontitis is a severe gum infection that can lead to tooth loss and other serious health complications. Periodontitis (per-e-o-don-TIE-tis), also called gum disease, is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth.
The aim of this trial is to evaluate in stage III/IV periodontitis the clinical efficacy of the adjunctive use of Nd:YAG laser, applied with two different protocols, to full-mouth scaling and root planing (FMS), compared to FMS alone.
The application of neodymium-doped: yttrium aluminium garnet (Nd:YAG) laser irradiation as a tool in nonsurgical periodontal (gum) therapy is due to the anti-inflammatory and antimicrobial irradiation properties, which might enhance the effectiveness of traditional periodontal therapy. Full-mouth scaling includes the removal of hard and soft tissue deposits from the root of a periodontally-affected tooth.
Who can participate?
The study involved participants recruited from a pool of patients initially presented to the Periodontal Department, 401 Athens Military Hospital, Athens, Greece, seeking periodontal treatment. Every patient diagnosed with severe chronic generalized periodontitis was enrolled in the study.
What does the study involve?
Participants will be randomly allocated to receive either treatment as usual, or in addition one or two laser therapy sessions.
What are the possible benefits and risks of participating?
All patients received thorough periodontal treatment. There were no risks for the patients involved in the study.
Where is the study run from?
401 Athens MIlitary Hospital (Greece)
When is the study starting and how long is it expected to run for?
July 2014 to October 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Nikolaos Markou
markou@periodontist.gr
nimarkou@dent.uoa.gr
Contact information
Principal Investigator
2 Thivon Street
Athens
11527
Greece
 ORCID ID |
0000-0003-3969-839X |
|---|---|
| Phone | +30 6944340393 |
| nimarkou@dent.uoa.gr |
Study information
| Study design | Double-masked parallel-arm randomized controlled 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 contact details to request a participant information sheet |
| Scientific title | Adjunctive Nd:YAG laser irradiation in the treatment of stage III/IV periodontitis. A 12-month, randomized, controlled trial. |
| Study objectives | Adjunctive Nd:YAG laser irradiation in the treatment of III/IV periodontitis ameliorates the results of non-surgical periodontal therapy as a monotherapy. |
| Ethics approval(s) | Approved 31/07/2014, Ethical Committee of the National and Kapodistrian University of Athens (2 Thivon Street, Athens, Goudi, Greece 11527; +30 2107461203; vanag@dent.uoa.gr), ref: 252/31-07-2014 |
| Health condition(s) or problem(s) studied | Adjunctive Nd:YAG laser in non-surgical periodontal therapy |
| Intervention | The study includes two test and one control group with a parallel design. The 3 patient groups consist of 60 patients, who initially will receive non-surgical periodontal treatment in two consecutive sessions, under local anesthesia. After completion of non-surgical therapy, the 60 patients will consecutively be randomized into 3 treatment groups (Laser 1, Laser 2, control). For both test groups, an Nd:YAG Laser (1064 nm) will be utilized. For Laser 1 group, laser therapy will be performed once, 1 week after scaling and root-planing. For Laser 2 group, laser therapy will be performed 1 week after scaling and root-planing and be repeated 1 week later, with identical laser settings. Randomization was performed using a blocked randomization list stratified by sex and smoking status with a block size of 6. The list was created using the Sealed Envelope online tool. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Assessed before treatment initiation and at 6 weeks, 3-, 6- and 12 months post-treatment: PD, CAL, gingival recession (GR), full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), simplified gingival index (GI). All clinical measurements were taken using a manual probe. PD, CAL and GR were performed at six sites per tooth, while FMPS, GI and FMBS were recorded at four sites per tooth. Third molars were excluded from the measurements. |
| Secondary outcome measures | Immediately after treatment, sixty (60) questionnaire forms were provided to each subject. Patients were asked to fill out the questionnaire at the end of the first week of the completion of treatment. A visual analogue scale was used to assess patients’ perception of pain, sensitivity discomfort, swelling, bleeding and acceptance of the protocol during and after treatment. They were also asked to answer if they should suggest the treatment to a friend. This scale ranged from 0 to 10. Subjects marked a point on a 10-cm-long uncalibrated line with the negative extreme response (0) on the left end and the positive extreme response (10) at the right end. Additionally, the numbers of analgesic tablets taken were assessed. |
| Overall study start date | 31/07/2014 |
| Completion date | 14/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 20 patients per treatment group |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. 35 - 65 years-old 2. Presence of at least 16 teeth 3. Periodontitis with PD ≥5 mm with bleeding on probing (BOP) in at least 30% of the teeth |
| Key exclusion criteria | 1. Poorly controlled diabetes 2. Autoimmune diseases 3. Genetic disorders 4. Bone metabolic diseases 5. Bisphosphonate drugs 6. Drug-induced gingival overgrowth 7. Tumours or other oral pathology 8. Pregnant or lactating women 9. Antibiotic use for any purpose within 3 months before entering the study |
| Date of first enrolment | 24/11/2015 |
| Date of final enrolment | 14/10/2020 |
Locations
Countries of recruitment
- Greece
Study participating centre
Athens
11525
Greece
Sponsor information
University/education
2 Thivon Street
Athens
11527
Greece
| Phone | +30 2107461203 |
|---|---|
| vanag@dent.uoa.gr | |
| Website | http://en.uoa.gr/ |
"ROR" |
https://ror.org/04gnjpq42 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 05/01/2023 | 05/01/2023 | No | No | |
| Results article | 16/02/2023 | 17/02/2023 | Yes | No | |
| Results article | 10/10/2023 | 11/10/2023 | Yes | No |
Additional files
Editorial Notes
11/10/2023: Publication reference added.
21/07/2023: The following changes have been made:
1. The study design has been changed from "Double-blind randomized controlled trial" to "Double-masked parallel-arm randomized controlled trial".
2. The recruitment start date has been changed from 13/04/2016 to 24/11/2015.
3. The overall study end date has been changed from 30/10/2020 to 14/10/2020.
17/02/2023: Publication reference added.
05/01/2023: A basic results summary has been uploaded.
04/01/2023: The intention to publish date has been changed from 12/06/2022 to 30/09/2023.
03/01/2023: The IPD sharing statement has been changed from "The datasets generated during and/or analysed during the current study are stored in a non-publicly available repository" to "The datasets generated during and/or analysed during the current study will be published as a supplement to the results publication".
15/08/2022: The IPD sharing statement has been changed from "The datasets generated during and/or analysed during the current study are/will be available upon request from markou@periodontist.gr" to "The datasets generated during and/or analysed during the current study are stored in a non-publicly available repository".
09/06/2022: Trial's existence confirmed by National and Kapodistrian University of Athens.
