Diode Laser 635 nm and 810 nm Photodynamic Therapy as Adjuncts to Non-Surgical Periodontal Treatment
Clinical Effectiveness of Diode Laser 635 nm and 810 nm Adjunctive Photodynamic Therapy Versus Mechanical Treatment in Non-Surgical Management of Periodontal Pockets (A Comparative Clinical Study).
This study aims to evaluate and compare the clinical effectiveness of antimicrobial photodynamic therapy (aPDT) using toluidine blue O (TBO) activated by two different diode laser wavelengths as an adjunct to non-surgical periodontal treatment in patients with Stage II and Stage III periodontitis. Participants will be randomly allocated to three treatment groups: non-surgical periodontal treatment combined with aPDT using a 635 nm diode laser, non-surgical periodontal treatment combined with aPDT using an 810 nm diode laser, and non-surgical periodontal treatment alone. The treatment outcomes will be evaluated based on changes in the following clinical periodontal parameters: Plaque Index (PI), Bleeding on Probing (BOP), Relative Attachment Level (RAL), Probing Depth (PD), and Gingival Recession (GR).
研究概览
地位
条件
详细说明
Several considerations support the need for this study. First, periodontal pockets are among the most common clinical manifestations of periodontal disease. There is also a need for effective treatment modalities that can complement the first-line approach of mechanical periodontal treatment, particularly in deep periodontal pockets and anatomically complex areas.
Antimicrobial photodynamic therapy (aPDT) is an emerging and promising technology in dentistry; however, findings from studies worldwide regarding its superiority over mechanical treatment remain inconsistent. Furthermore, there is a lack of studies directly comparing aPDT using different laser wavelengths with conventional mechanical treatment. Therefore, the findings of this study may provide evidence to support the selection of a more effective treatment option for patients based on scientific evidence.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：SANA MAJALDEEN SALMAN, pursuing aMSc in periodontolog
- 电话号码：00963936320891
- 邮箱：sansoun.net@gmail.com
研究联系人备份
- 姓名：Wael HosamAldin Almahdi, DDS; MSc; PHD in periodontolog
- 电话号码：00963933408906
- 邮箱：wael2.mahdi@damascusuniversity.edu.sy
学习地点
-
-
-
Damascus、叙利亚
- The study will be conducted at the Faculty of Dentistry, Damascus University, Department of Periodontology, under the supervision of Professor Wael Al- Mahdi.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults aged 18 years or older (up to 65 years)
- Participants diagnosed with Periodontitis Stage II-III according to the 2017 classification
- Presence of at least 3 periodontal sites with a probing pocket depth (PPD) of ≥ 5 mm.
- No periodontal treatment during the previous 6 months
- Good general health
Exclusion Criteria:
- Presence of systemic diseases or medical conditions that may affect periodontal status, wound healing, or the response to periodontal treatment.
- Use of systemic antibiotics or other medications that may significantly affect periodontal treatment outcomes within the last 6 months.
- Previous periodontal treatment within the last 6 months.
- Known allergy or hypersensitivity to toluidine blue O or any material used in the study.
- Pregnancy or breastfeeding.
- Heavy smoking >10 units/day
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm 1: 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment
Participants will receive non-surgical periodontal treatment combined with antimicrobial photodynamic therapy (aPDT) using toluidine blue O activated by a 635 nm diode laser. |
Participants assigned to this group will undergo non-surgical periodontal treatment with subgingival mechanical instrumentation using slim ultrasonic scaler tips. Antimicrobial photodynamic therapy will then be performed using toluidine blue O as the photosensitizing agent, activated by a 635 nm diode laser. The same treatment procedure will be repeated after two weeks. |
|
实验性的：Arm 2: 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment
Participants will receive non-surgical periodontal treatment combined with antimicrobial photodynamic therapy (aPDT) using toluidine blue O activated by an 810 nm diode laser. |
Participants assigned to this group will undergo non-surgical periodontal treatment with subgingival mechanical instrumentation using slim ultrasonic scaler tips. Antimicrobial photodynamic therapy will then be performed using toluidine blue O as the photosensitizing agent, activated by an 810 nm diode laser. The same treatment procedure will be repeated after two weeks. |
|
有源比较器：Arm 3: Non-Surgical Periodontal Treatment Alone (Control)
Participants will receive non-surgical periodontal treatment alone, consisting of subgingival mechanical instrumentation using slim ultrasonic scaler tips, without photodynamic therapy. |
Participants assigned to the control group will receive non-surgical periodontal treatment consisting of subgingival mechanical instrumentation using slim ultrasonic scaler tips. No photodynamic therapy or laser application will be performed. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in probing pocket depth (PPD).
大体时间：Baseline to 3 months after the first treatment session.
|
Probing pocket depth will be measured in millimeters from the free gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at standardized sites. |
Baseline to 3 months after the first treatment session.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Relative attachment level (RAL)
大体时间：from baseline to 3 months
|
Relative attachment level (RAL) will be measured in millimeters from a standardized fixed reference point on a vacuum stent to the base of the periodontal pocket, measured using a UNC-15 periodontal probe. |
from baseline to 3 months
|
|
Change in Gingival Recession (GR).
大体时间：At baseline then 1 month and 3 months after the first session.
|
Gingival Recession (GR) will be measured in millimeters from the cementoenamel junction (CEJ) to the most apical point of the gingival margin, using a UNC-15 periodontal probe. |
At baseline then 1 month and 3 months after the first session.
|
|
Change in Bleeding on Probing (BOP)
大体时间：At baseline then 1 month and 3 months after the first session.
|
The presence or absence of bleeding following standardized periodontal probing to the base of the periodontal pocket. BOP will be recorded as a dichotomous outcome (present/absent) at the selected periodontal sites, and the percentage of BOP-positive sites will be calculated at baseline and at each follow-up visit. |
At baseline then 1 month and 3 months after the first session.
|
合作者和调查者
出版物和有用的链接
一般刊物
- Zhang X, Hu Z, Zhu X, Li W, Chen J. Treating periodontitis-a systematic review and meta-analysis comparing ultrasonic and manual subgingival scaling at different probing pocket depths. BMC Oral Health. 2020 Jun 25;20(1):176. doi: 10.1186/s12903-020-01117-3.
- Nie M, Zhang P, Pathak JL, Wang X, Wu Y, Yang J, Shen Y. Photodynamic therapy in periodontitis: A narrative review. Photodermatol Photoimmunol Photomed. 2024 Jan;40(1):e12946. doi: 10.1111/phpp.12946.
- Annaji S, Sarkar I, Rajan P, Pai J, Malagi S, Bharmappa R, Kamath V. Efficacy of Photodynamic Therapy and Lasers as an Adjunct to Scaling and Root Planing in the Treatment of Aggressive Periodontitis - A Clinical and Microbiologic Short Term Study. J Clin Diagn Res. 2016 Feb;10(2):ZC08-12. doi: 10.7860/JCDR/2016/13844.7165. Epub 2016 Feb 1.
- Chungkham S, Sambashivaiah S, Kulal R, Devi AN. Comparison of Photodynamic Therapy (PDT) Using Methylene Blue and Toluidine Blue for the Treatment of Chronic Periodontitis- A Clinical and Microbiological Study. J Pharm Bioallied Sci. 2025 Jun;17(Suppl 2):S1353-S1355. doi: 10.4103/jpbs.jpbs_124_25. Epub 2025 Jun 18.
- Maj A, Kusiak A, Garbacz K, Cichonska D, Swietlik D. Photodynamic therapy in non-surgical treatment of periodontitis. Sci Rep. 2025 Feb 18;15(1):5903. doi: 10.1038/s41598-025-89563-3.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.