Is combined laser treatment effective for patients with periodontal disease?
| ISRCTN | ISRCTN11340841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11340841 |
- Submission date
- 21/11/2021
- Registration date
- 24/11/2021
- Last edited
- 10/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims：
Periodontitis (gum disease) is an infection of the gums that can lead to tooth loss. In recent years, many types of dental lasers have been used for the non-surgical treatment of periodontal diseases. However, it remains unclear whether the combined application of lasers is effective as an adjuvant treatment for chronic periodontitis. The purpose of this study is to compare the use of combined treatment with Er: YAG laser and low-level diode laser, to treatment with the Er: YAG laser only, to treatment with the low-level diode laser only, and to traditional treatment of periodontal diseases in a Chinese population.
Who can participate?
Chronic periodontitis patients aged between 35 and 70 years in Beijing.
What does the study involve?
This study will use a split-mouth design, where patients will receive multiple different treatments to different sections of the mouth to control for the difference between each patient. Each quadrant (right upper jaw, left upper jaw, left lower jaw, right lower jaw) will be randomly allocated to receive one of four treatment groups: combined treatment with Er: YAG laser and low-level diode laser; treatment with the Er: YAG laser only; treatment with the low-level diode laser only; and traditional treatment. Clinical periodontal examinations were evaluated at baseline, 3 months, and 6 months.
What are the possible benefits and risks of participating?
In addition to traditional periodontal therapy, participants will receive free laser treatment in the experimental quadrants. Side effects of the treatments may include a small amount of pain in the gum for one or two days after the treatment.
Where is the study run from?
Department of Stomatology of Beijing Chao-Yang Hospital (China)
When is the study starting and how long is it expected to run for?
From August 2021 to July 2022
Who is funding the study?
Beijing Municipal Science & Technology Commission (China)
Who is the main contact?
Prof. Zhou
xuanzhou2004@hotmail.com
Contact information
Scientific
Department of Stomatology
Beijing Chao-Yang Hospital
Capital Medical University
Chao Yang District
Beijing
100020
China
 ORCID ID |
0000-0003-2522-1283 |
|---|---|
| Phone | +86-10-85231344 |
| xuanzhou2004@hotmail.com |
Study information
| Study design | Interventional single-centre single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Combined application of Er:YAG and low level diode lasers in treatment of periodontitis: A split-mouth, randomized controlled trial |
| Study objectives | Combined application of Er:YAG and Low level diode lasers may provide more effective treatment than conventional scaling and root planing |
| Ethics approval(s) | Approved 03/09/2021, Ethics Committee of the Beijing Chao-Yang Hospital (No.8 GongRenTiYuChangNanLu, Chao Yang District, Beijing, P.R.China 100020; +86-10-85231484; no email address available), ref: 2021-Sci-558 |
| Health condition(s) or problem(s) studied | Moderate or severe periodontitis |
| Intervention | The study will use a split-mouth design, with each patient serving as their own control. Each quadrant (right upper jaw, left upper jaw, left lower jaw, right lower jaw) will be randomly allocated into four test groups (A group, B group, C group) or control group (D group). A group will receive Er:YAG laser plus low level diode laser treatment (LLLT), B group will receive Er:YAG laser only, C group will receive LLLT only, while the control quadrants will receive traditional treatment only. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Probing depth (PD) measured using periodontal probing at baseline, 3 months, and 6 months 2. Clinical attachment level (CAL) measured using periodontal probing at baseline, 3 months, and 6 months |
| Secondary outcome measures | 1. Bleeding index (BI) measured using periodontal probing at baseline, 3 months, and 6 months 2. Plaque index (PLI) assessed by an examiner using a scale of 0 to 3 (where 0= No plaque, 1= Cannot see plaque but plaque can be detected with probe, 2= Moderate plaque can be seen, and 3= Lots of plaque can be seen) at baseline, 3 months, and 6 months |
| Overall study start date | 01/08/2021 |
| Completion date | 11/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 24 |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Aged 35-70 years 2. Minimum of 20 teeth (4 per quadrant) 3. It is clinically diagnosed as extensive stage III-IV periodontal disease: the heaviest site of interproximal attachment loss is ≥5 mm, radiologic bone loss extends to 1/3 of the root and above, PD ≥ 6mm, vertical bone absorption ≥3 mm, cumulative bone resorption >30% 4. Good general health |
| Key exclusion criteria | 1. Received periodontal treatment within the previous 6 months 2. Received systemic antibiotic therapy within the previous 6 months 3. Suffered systemic diseases that could influence therapy outcome (e.g. diabetes mellitus, blood disease) 4. Pregnant |
| Date of first enrolment | 01/12/2021 |
| Date of final enrolment | 05/01/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Department of Stomatology
Capital Medical University
Chao Yang District
Beijing
100020
China
Sponsor information
Hospital/treatment centre
No.8 GongRenTiYuChangNanLu
Department of Stomatology
Capital Medical University
Chao Yang District
Beijing
100020
China
| Website | http://www.bjcyh.com.cn |
|---|
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Science and Technology Commission of Beijing Municipality, Beijing Municipal Science & Technology Commission, Adminitrative Commission of Zhongguancun Science Park, Beijing Municipal Science and Technology Commission, Beijing Municipal Science & Technology Commission, 北京市科学技术委员会, 北京市科学技术委员会, 中关村科技园区管委会
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer- reviewed journal |
| IPD sharing plan | The trial individual data were collected and are maintained by the Department of Stomatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. The corresponding author takes full responsibility for the acquisition, management, analysis, and interpretation of data for this trial. The individual trial data will not be made available to the public but may be available for researchers upon their reasonable request to xuanzhou2004@hotmail.com. Each participant of the trial will give informed consent before enrolment. The data will become available three months after the trial end date. The trial data will be stored in the SPSS documents. SPSS statistical package (Version 18.0; SPSS Inc.) was used for data analyses. The distributions of all outcome values were examined using the Kolmogorov–Smirnov normality test. Since they were all normally distributed, baseline characteristics between four quarters were compared using one way ANOVA test. Pair‐wise comparisons within each treatment groups (3 months vs. baseline and 6 months vs. baseline) were performed by least significant difference (LSD) method. The level of significance was set at p < 0.05 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/08/2024 | 10/01/2025 | Yes | No |
Editorial Notes
10/01/2025: Publication reference added.
13/08/2024: Study record confirmed as up to date.
16/08/2023: The intention to publish date has been changed from 01/07/2023 to 31/12/2024.
14/07/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2022 to 11/07/2022.
2. The recruitment end date was changed from 31/12/2021 to 05/01/2022.
3. The total final enrolment was added.
4. The plain English summary was updated to reflect these changes.
23/11/2021: Trial’s existence confirmed by Ethics Committee of the Beijing Chao-Yang Hospital.
