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Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis

Efficacy of Antimicrobial Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07609888
Acronym
aPDT-NSPT
Enrollment
30
Registered
2026-05-27
Start date
2023-06-01
Completion date
2024-06-15
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis (Disorder), Periodontitis

Keywords

Photodynamic therapy, Antimicrobial photodynamic therapy, Non-surgical periodontal therapy, Periodontal debridement, Indocyanine green, Diode laser, Split-mouth clinical trial, Pocket depth reduction, Clinical attachment level, Bleeding on probing, Subgingival debridement, Periodontal pathogens

Brief summary

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

Detailed description

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.

Interventions

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.

DEVICEAntimicrobial 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.

Sponsors

Gulf Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

he outcomes assessor was masked to treatment allocation during clinical parameter recording. Standardized acrylic stents and a UNC-15 mm periodontal probe were used to ensure consistent and unbiased measurements at baseline and three months.

Intervention model description

Split-mouth design in which each participant contributed two sites - one control site receiving NSPT alone and one test site receiving NSPT with adjunct antimicrobial photodynamic therapy. Each participant served as their own control, with random allocation of sites to treatment arms.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Probing Pocket Depth (PD)Baseline and 3 monthsProbing 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.

Secondary

MeasureTime frameDescription
Change in Bleeding on Probing (BOP)Baseline and 3 monthsBleeding 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.
Change in Gingival RecessionBaseline and 3 monthsGingival 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.
Change in Clinical Attachment Level (CAL)Baseline and 3 monthsClinical 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.

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026