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).
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: SANA MAJALDEEN SALMAN, pursuing aMSc in periodontolog
- Número de teléfono: 00963936320891
- Correo electrónico: sansoun.net@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Wael HosamAldin Almahdi, DDS; MSc; PHD in periodontolog
- Número de teléfono: 00963933408906
- Correo electrónico: wael2.mahdi@damascusuniversity.edu.sy
Ubicaciones de estudio
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Damascus, Siria
- The study will be conducted at the Faculty of Dentistry, Damascus University, Department of Periodontology, under the supervision of Professor Wael Al- Mahdi.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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. |
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Experimental: 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. |
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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in probing pocket depth (PPD).
Periodo de tiempo: Baseline to 3 months after the first treatment session.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Relative attachment level (RAL)
Periodo de tiempo: from baseline to 3 months
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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
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Change in Gingival Recession (GR).
Periodo de tiempo: At baseline then 1 month and 3 months after the first session.
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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.
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Change in Bleeding on Probing (BOP)
Periodo de tiempo: At baseline then 1 month and 3 months after the first session.
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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.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UDDS-2026-Perio-13
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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