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- Ensayo clínico NCT07609888
Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis (aPDT-NSPT)
Efficacy of Antimicrobial Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study
Gum disease (periodontitis) affects millions of people worldwide and can lead to tooth loss if untreated. The standard treatment is a deep cleaning procedure called non-surgical periodontal therapy (NSPT), where a dentist removes bacterial buildup from beneath the gums. Sometimes, harmful bacteria remain after this cleaning and the disease can return.
This study tests whether adding a light-based antibacterial treatment - called photodynamic therapy (PDT) - to the standard deep cleaning improves results. PDT works by placing a harmless green dye (indocyanine green) into the gum pocket, then shining a specific laser light on it. The light activates the dye and kills the remaining bacteria without antibiotics.
Who can join: Adults aged 18 and over diagnosed with moderate gum disease (Stage II periodontitis) with gum pocket depths of 4-5 mm.
How it works: Each participant receives both treatments - standard cleaning on one side of the mouth, and standard cleaning plus PDT on the other side. This allows a fair comparison within the same person.
What is measured: Gum pocket depth, gum attachment level, and gum bleeding - checked at the start of the study and again after 3 months.
The study was conducted at Thumbay University Hospital, UAE
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Detailed Description Periodontitis is a multifactorial inflammatory disease driven by a dysbiotic subgingival microbiome. Despite non-surgical periodontal therapy (NSPT) being the gold standard, complete bacterial elimination is not always achieved, and residual periodontal pathogens such as Porphyromonas gingivalis and Treponema denticola can persist post-treatment. This has led to the exploration of adjunctive therapies to enhance clinical outcomes.
Antimicrobial photodynamic therapy (aPDT) is a non-antibiotic adjunct that uses a photosensitizing dye activated by laser light of a specific wavelength. Upon activation in the presence of oxygen, the dye generates cytotoxic reactive oxygen species and singlet oxygen, which disrupt bacterial cell membranes and DNA. Indocyanine green (ICG), a near-infrared photosensitizer with peak absorption in the 800-830 nm range, demonstrates high uptake among key periodontal pathogens and carries no risk of inducing antimicrobial resistance.
Study Rationale:
Current systematic reviews on aPDT as an adjunct to NSPT report contradictory findings, often attributed to heterogeneous study designs, mixed periodontitis staging, and short follow-up periods. This study addresses these limitations by focusing exclusively on a well-defined patient population with Stage II periodontitis and employing a split-mouth design to minimize inter-subject variability.
Intervention Protocol:
Control sites (NSPT alone):
Supragingival and subgingival debridement was performed using an ultrasonic scaler, followed by subgingival root instrumentation using Gracey curettes (11/12). A customized acrylic stent with a UNC-15 mm periodontal probe was used to standardize probing measurements.
Test sites (NSPT + aPDT):
Following NSPT, indocyanine green dye was reconstituted at a concentration of 5 mg/ml and delivered into the periodontal pocket via a 27-gauge needle, placed to the base of the pocket and withdrawn coronally while injecting. The photosensitizer was then activated using an Elexxion AG 810 nm diode laser, with the fiber tip moved in an apico-coronal direction parallel to the root surface within the pocket.
Randomization:
Sites were randomly allocated to test or control groups using a split-mouth design, ensuring contralateral teeth were assigned to different treatment groups.
Follow-up:
All clinical parameters - probing pocket depth (PD), clinical attachment level (CAL), gingival recession, and bleeding on probing (BOP) - were recorded at baseline and at three months post-treatment by a calibrated examiner using standardized acrylic stents.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ajman, Emiratos Árabes Unidos
- Thumbay University Hospital, Postgraduate Research Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- - Adults aged 18 years and older
- Diagnosis of Stage II periodontitis according to the 2018 classification of the World Workshop of Periodontology (AAP/EFP)
- At least two non-adjacent sites with interproximal probing pocket depth of 4-5 mm
- Interproximal clinical attachment loss of 3-4 mm at affected sites
- Willing and able to provide written informed consent
Exclusion Criteria:
- Periodontal therapy including scaling and root debridement within the last 12 months
- Antibiotic use or regular use of mouthwash in the 3 months prior to enrollment
- Pregnancy
- Any systemic condition that may affect periodontal healing (e.g. uncontrolled diabetes, immunocompromised states)
- Regular use of hormonal contraceptives
- Smoking more than 10 cigarettes per day
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: NSPT Alone (Control)
Control sites received full-mouth non-surgical periodontal therapy (NSPT) consisting of supragingival and subgingival debridement using an ultrasonic scaler and Gracey curettes (Hu-Friedy, Chicago, IL).
Oral hygiene instructions were reinforced at each visit.
Pocket depth was standardized using an individualized acrylic resin occlusal stent with a UNC-15 periodontal probe.
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Full-mouth mechanical debridement using ultrasonic scaling and area-specific Gracey curettes to remove supra- and subgingival calculus and plaque biofilm.
Applied to all sites in both arms.
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Experimental: NSPT + Antimicrobial Photodynamic Therapy (Test)
Test sites received full-mouth NSPT followed by adjunctive antimicrobial photodynamic therapy (aPDT).
Indocyanine green (ICG) dye was reconstituted at 5 mg/ml and delivered to the base of the periodontal pocket via a 27-gauge needle using a coronal withdrawal technique.
The photosensitizer was activated using an Elexxion AG 810 nm diode laser, with the fiber tip moved in an apico-coronal direction parallel to the root surface within the pocket.
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Full-mouth mechanical debridement using ultrasonic scaling and area-specific Gracey curettes to remove supra- and subgingival calculus and plaque biofilm.
Applied to all sites in both arms.
Dispositivo: Antimicrobial Photodynamic Therapy (aPDT) with Indocyanine Green and 810 nm Diode Laser
Indocyanine green (ICG) photosensitizing dye (25 mg lyophilized powder reconstituted to 5 mg/ml with sterile water) was delivered into the periodontal pocket via a 27-gauge needle.
The dye was then activated using an Elexxion AG 810 nm diode laser.
The laser fiber tip was positioned at the base of the pocket and moved in an apico-coronal direction parallel to the root surface.
Applied to test sites only, immediately following NSPT.
Otros nombres:
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¿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 (PD)
Periodo de tiempo: Baseline and 3 months
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Probing pocket depth measured in millimeters using a UNC-15 mm periodontal probe standardized with an individualized acrylic resin occlusal stent.
Measurements recorded at the mesio-buccal surface of the assigned tooth in both control and test sites.
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Baseline and 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Bleeding on Probing (BOP)
Periodo de tiempo: Baseline and 3 months
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Bleeding on probing recorded as a percentage of sites exhibiting bleeding following gentle probing of the periodontal pocket.
Presence or absence of bleeding noted within 30 seconds of probing at each designated site.
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Baseline and 3 months
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Change in Gingival Recession
Periodo de tiempo: Baseline and 3 months
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Gingival recession measured in millimeters as the distance from the cemento-enamel junction to the free gingival margin using a UNC-15 mm periodontal probe standardized with an individualized acrylic resin occlusal stent.
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Baseline and 3 months
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Change in Clinical Attachment Level (CAL)
Periodo de tiempo: Baseline and 3 months
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Clinical attachment level measured in millimeters as the distance from the cemento-enamel junction to the base of the periodontal pocket, using a UNC-15 mm periodontal probe standardized with an individualized acrylic resin occlusal stent.
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Baseline and 3 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
- Chambrone L, Wang HL, Romanos GE. Antimicrobial photodynamic therapy for the treatment of periodontitis and peri-implantitis: An American Academy of Periodontology best evidence review. J Periodontol. 2018 Jul;89(7):783-803. doi: 10.1902/jop.2017.170172.
- Salvi GE, Stahli A, Schmidt JC, Ramseier CA, Sculean A, Walter C. Adjunctive laser or antimicrobial photodynamic therapy to non-surgical mechanical instrumentation in patients with untreated periodontitis: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:176-198. doi: 10.1111/jcpe.13236.
- Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Enfermedades periodontales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Condiciones Patológicas, Signos y Síntomas
- Periodontitis
- Periodontitis Crónica
- Terapéutica
- Terapia con drogas
- Equipos y suministros
- Láser
- Dispositivos ópticos
- Equipos y suministros de radiación
- Terapia de modalidad combinada
- Fototerapia
- Láseres, semiconductores
- Fotoquimioterapia
Otros números de identificación del estudio
- Mds2022-01
- 2021MDSPerio01 (Otro identificador: Gulf Medical University MDS Thesis 2023-2024)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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