The role of diode laser in the management of periodontitis among hemodialysis patients
| ISRCTN | ISRCTN10338466 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10338466 |
| Secondary identifying numbers | 164 |
- Submission date
- 04/08/2024
- Registration date
- 07/08/2024
- Last edited
- 12/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The kidney is considered one of the important organs in maintaining the human body’s normal functions, and any disturbance in its function negatively affects general health. Therefore, to avoid any dangerous complications among chronic kidney disease patients, hemodialysis is used to replace normal kidney function.
Oral tissues may also be affected by the disease, especially in its final stages and by the medication and hemodialysis process.
Periodontal (gum) disease is considered one of the most important manifestations associated with kidney disease. If left untreated, it may cause teeth loss and halitosis (bad breath) and increase the systemic inflammatory burden in the body. It is usually treated by scaling and root planing.
Recently, the application of dental lasers such as diode or Nd:YAG could improve the healing process and support periodontal tissues, which might be due to the laser's thermal antibacterial effects on oral tissues. The aim of this study is to assess the effect of diode laser as an adjacent treatment to scaling and root planing on oral and periodontal health among hemodialysis patients.
Who can participate?
Patients aged 20-50 years with chronic kidney disease undergoing hemodialysis.
What does this study involve?
Participants are randomly allocated to the two treatment methods: traditional scaling and root planing (SRP), and SRP + diode laser application. Oral health and hygiene instructions are provided for all patients.
What are the possible benefits and risks of participating?
Benefits may include periodontal health improvement, preventing tooth loss, and reduced inflammation. Patients will be more aware of their oral health and its importance for their quality of life. Possible risks might include some pain and discomfort after the laser application.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
August 2021 to September 2023
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Samer AlTarsha, samer.altarsha@damascusuniversity.edu.sy
Contact information
Public, Scientific, Principal Investigator
Hamish Highway
Damascus
4671
Syria
| Phone | +963 (0)932759493 |
|---|---|
| samer.altarsha@damascusuniversity.edu.sy |
Study information
| Study design | Single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Prevention, Treatment |
| Participant information sheet | 45891_PIS.pdf |
| Scientific title | Diode laser as an adjacent treatment to scaling and root planing – oral and periodontal health among hemodialysis patients – a randomized single-blinded clinical trial |
| Study objectives | h0: There are no statistical differences between both treatment groups (SRP vs SRP and diode laser) regarding the clinical studies indices. h1: There are statistically significant differences between both treatment groups (SRP vs SRP and diode laser) regarding the clinical studies indices. |
| Ethics approval(s) |
Approved 27/09/2021, Scientific ethics committee at Damascus University. (Baramkeh, Damascus, 4671, Syria; +963 (0)1133923223; ap.srd@damascusuniversity.edu.sy), ref: 3398 |
| Health condition(s) or problem(s) studied | Periodontal disease among hemodialysis patients |
| Intervention | This study is designed to compare traditional non-surgical treatment (scaling and root planing), and scaling and root planing with the use of diode laser 810 nm. This is a split-mouth design study in which both treatment groups were randomly selected for each half of the jaws for every patient. |
| Intervention type | Mixed |
| Primary outcome measure | Relative attachment level (RAL), defined as the distance from the highest point of the teeth (incisal edge in anterior teeth and occlusal edge in posterior teeth) to the bottom of the periodontal pocket. It approximately measures bone loss due to periodontal disease. Measured using a periodontal probe (UNC15) at baseline and after a 3-month follow-up appointment. |
| Secondary outcome measures | 1. Periodontal probing depth (PPD), defined as the distance from the free gingival margin to the bottom of the periodontal pocket. Measured using a periodontal probe (UNC15) at baseline and after a 3-month follow-up appointment. 2. Level of oral hygiene and periodontal health measured using the Simplified Oral Hygiene Index (SOHI) at baseline and after a 3-month follow-up appointment. |
| Overall study start date | 01/08/2021 |
| Completion date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. Chronic kidney disease patients 2. Patients undergoing hemodialysis twice a week 3. Patients with more than eight teeth in each half of their oral cavity 4. Aged 20-50 years |
| Key exclusion criteria | 1. Pregnancy 2. Diabetes patients 3. Patients who underwent an antibiotic therapy course in the last 6 months 4. Patients who underwent periodontal treatment in the last 6 months 5. Chemotherapy patients |
| Date of first enrolment | 10/05/2022 |
| Date of final enrolment | 20/08/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Oral Medicine Department
Mazzeh Highway
Damscus
4671
Syria
Sponsor information
University/education
Baramkeh
Damascus
4671
Syria
| Phone | +963 (0)1133923223 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and analyzed during the current study are available upon request from Samer AlTarsha (sameraltarsha@gmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 07/08/2024 | No | No | ||
| Participant information sheet | 07/08/2024 | No | Yes |
Additional files
Editorial Notes
12/08/2024: The ethics reference number was changed from 2721 to 3398.
05/08/2024: Study's existence confirmed by Damascus University.
